Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT01635218
Status:
COMPLETED
Last Update Posted:
2014-10-09
First Post:
2012-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Homeopathic Treatment for Depression in Peri- and Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008419', 'term': 'Materia Medica'}, {'id': 'D006705', 'term': 'Homeopathy'}, {'id': 'D005473', 'term': 'Fluoxetine'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ecmc2008@hotmail.es', 'phone': '+52 55 5747 7605', 'title': 'Dr. Emma del Carmen Macías-Cortés', 'organization': 'Hospital Juárez de México'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During study duration and 2 weeks after the final dose (8 weeks).', 'description': "Daily patient's questionnaire and medical examination at each follow-up.", 'eventGroups': [{'id': 'EG000', 'title': 'Individualized Homeopathic Treatment', 'description': 'Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.\n\nIndividualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms.', 'otherNumAtRisk': 44, 'otherNumAffected': 19, 'seriousNumAtRisk': 44, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fluoxetine', 'description': 'Selective serotonin reuptake inhibitor.\n\nFluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded could be repeated at week 4.', 'otherNumAtRisk': 46, 'otherNumAffected': 24, 'seriousNumAtRisk': 46, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Fluoxetine placebo plus individualized homeopathic placebo\n\nPlacebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4.', 'otherNumAtRisk': 43, 'otherNumAffected': 16, 'seriousNumAtRisk': 43, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in 17-item Hamilton Rating Scale for Depression at 6 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Individualized Homeopathic Treatment', 'description': 'Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.\n\nIndividualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms.'}, {'id': 'OG001', 'title': 'Fluoxetine', 'description': 'Selective serotonin reuptake inhibitor.\n\nFluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Fluoxetine placebo plus individualized homeopathic placebo\n\nPlacebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'spread': '3', 'groupId': 'OG000'}, {'value': '11.7', 'spread': '3.7', 'groupId': 'OG001'}, {'value': '15', 'spread': '3.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.0', 'ciLowerLimit': '3.1', 'ciUpperLimit': '7.0', 'pValueComment': 'The ANOVA result (p\\<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.05', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.2', 'ciLowerLimit': '1.31', 'ciUpperLimit': '5.25', 'pValueComment': 'The ANOVA result (p\\<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.81', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 weeks', 'description': '17-item Hamilton Rating Scale for Depression (HRSD) is a well-known standardized scale used worldwide to assess severity of depression. Score ranges from 0 (no depression) up to 52 (maximum depression severity). A total score in HRSD was assessed at baseline and after six weeks of treatment. For this study the change was calculated as the later time point (total score in 17- HRSD at 6 weeks) minus the earlier time point (total score at baseline). A score \\< or = 7 is considered normal, 7 - 13 (mild depression), 14 - 24 (moderate to severe depression), \\> 24 (severe depression).', 'unitOfMeasure': 'Units in Hamilton Scale', 'dispersionType': 'Standard Deviation', 'populationDescription': 'All patients under randomization were included in the primary efficacy population (intention-to-treat population), regardless whether or not they adhered to the treatment protocol or provided complete data sets.The mean and SD presented in outcome measure data table are the final scores in Hamilton Scale after 6 weeks of treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Beck Depression Inventory at 6 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Individualized Homeopathic Treatment', 'description': 'Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.\n\nIndividualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms.'}, {'id': 'OG001', 'title': 'Fluoxetine', 'description': 'Selective serotonin reuptake inhibitor.\n\nFluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Fluoxetine placebo plus individualized homeopathic placebo\n\nPlacebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '14.2', 'spread': '7.8', 'groupId': 'OG001'}, {'value': '15.5', 'spread': '8.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.14', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.4', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '7.61', 'pValueComment': 'The statistical significant ANOVA result (p\\<0.05) suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.71', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.99', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.28', 'ciLowerLimit': '-2.93', 'ciUpperLimit': '5.5', 'pValueComment': 'The ANOVA result (p\\<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.73', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Beck Depression Inventory (BDI) is a 21-question multiple-choice self-report inventory that assess severity of depression. A total score range was assessed at baseline and after six weeks of treatment. A score 0 (without depression) up to 63 (most severe depression). For this study the change was calculated as the later time point (total score in BDI at 6 weeks) minus the earlier time point (total score in BDI at baseline). A score 0 - 8 is considered normal, 9 - 18 (mild to moderate depression), 19 - 28 (moderate to severe depression), \\> 29 (severe depression).', 'unitOfMeasure': 'Units in Beck Depression Inventory', 'dispersionType': 'Standard Deviation', 'populationDescription': 'All patients under randomization were included in the primary efficacy population (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets. The mean and SD presented here in the Outcome measure data table are the final scores after 6 weeks treatment.'}, {'type': 'SECONDARY', 'title': 'Responder Rates at 6 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Individualized Homeopathic Treatment', 'description': 'Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.\n\nIndividualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms.'}, {'id': 'OG001', 'title': 'Fluoxetine', 'description': 'Selective serotonin reuptake inhibitor.\n\nFluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Fluoxetine placebo plus individualized homeopathic placebo\n\nPlacebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '0.03', 'ciUpperLimit': '0.34', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.05', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '0.06', 'ciUpperLimit': '0.56', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': '17-item Hamilton Rating Scale for Depression is a well-known standardized scale used worldwide to assess severity of depression. Score ranges from 0 (no depression) up to 52 (maximum depression severity). A total score in 17-item Hamilton Scale for Depression was assessed for this study. It ranges from 0 (no depression) up to 52 (most severe depression). A score \\< or = 7 is considered normal, 7 - 13 (mild depression), 14 - 24 (moderate to severe depression), \\> 24 (severe depression). Responder rate definition: a decrease of 50% or more from baseline score using 17-item Hamilton Rating Scale for Depression after six weeks treatment.', 'unitOfMeasure': 'participants with a decrease >50% in HS', 'populationDescription': 'All patients under randomization were included in the primary efficacy population (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Greene´s Scale at 6 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Individualized Homeopathic Treatment', 'description': 'Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.\n\nIndividualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms.'}, {'id': 'OG001', 'title': 'Fluoxetine', 'description': 'Selective serotonin reuptake inhibitor.\n\nFluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Fluoxetine placebo plus individualized homeopathic placebo\n\nPlacebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.1', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '23.1', 'spread': '12.3', 'groupId': 'OG001'}, {'value': '26.8', 'spread': '11.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.6', 'ciLowerLimit': '2.72', 'ciUpperLimit': '14.52', 'pValueComment': 'The ANOVA result (p\\<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.42', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.424', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.6', 'ciLowerLimit': '-2.33', 'ciUpperLimit': '9.6', 'pValueComment': 'The ANOVA result (p\\<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.37', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Greene Climacteric Scale (GS) is intended to be a standard measure of core climacteric symptoms. For this study a total range was assessed at baseline and after six weeks of treatment. A total score 0 (without climacteric symptoms) up to 63 (most severe climacteric symptoms). The change was calculated as the later time point (total score in GS at 6 weeks) minus the earlier time point (total score at baseline).The scale measures four separate sub-scales (anxiety, depression, somatic symptoms and sexual function). The score of the four sub-scales was summed. A total score of 0 -10 is considered without symptoms, 11 - 29 (mild symptoms), 30 - 49 (moderate symptoms) and \\> 50 (severe symptoms).', 'unitOfMeasure': 'Units in Green Scale', 'dispersionType': 'Standard Deviation', 'populationDescription': 'All patients under randomization were included in the primary efficacy population (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets.The mean and SD presented here in the Outcome measure data table are the final scores after 6 weeks treatment.'}, {'type': 'SECONDARY', 'title': 'Remission Rates at 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Individualized Homeopathic Treatment', 'description': 'Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.\n\nIndividualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms.'}, {'id': 'OG001', 'title': 'Fluoxetine', 'description': 'Selective serotonin reuptake inhibitor.\n\nFluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Fluoxetine placebo plus individualized homeopathic placebo\n\nPlacebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.10', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '0.26', 'ciLowerLimit': '0.05', 'ciUpperLimit': '1.32', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.11', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '0.05', 'ciUpperLimit': '1.39', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': '17-item Hamilton Rating Scale for Depression is a well-known standardized scale used worldwide to assess severity of depression. Score ranges from 0 (no depression) up to 52 (maximum depression severity). A total score in 17-item Hamilton Scale for Depression was assessed for this study. It ranges from 0 (no depression) up to 52 (most severe depression). A score \\< or = 7 is considered normal, 7 - 13 (mild depression), 14 - 24 (moderate to severe depression), \\> 24 (severe depression). Remission rate definition: 17-item Hamilton Rating Scale for Depression score \\< 7 points after 6 weeks of treatment.', 'unitOfMeasure': 'participants with a score of < 7 in HS', 'populationDescription': 'All patients under randomization were included in the primary efficacy population (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Individualized Homeopathic Treatment', 'description': 'Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.\n\nIndividualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms.'}, {'id': 'FG001', 'title': 'Fluoxetine', 'description': 'Selective serotonin reuptake inhibitor.\n\nFluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Fluoxetine placebo plus individualized homeopathic placebo\n\nPlacebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'The study was conducted in a public, academic and research hospital in Mexico City. Participants were recruited since March 2012 until December 2013. The recruitment methods included advertisements through internet, community groups,liaisons with health professionals, posters and brochures distributed among hospital population.', 'preAssignmentDetails': 'Five hundred thirty-four women seeking medical care for menopausal complaints were interviewed and screened. Four hundred and one women did not meet inclusion criteria and were excluded: no depression (44), mild depression (150), severe depression and/or attempt of suicide (43), did not meet other inclusion criteria (164).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '133', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Individualized Homeopathic Treatment', 'description': 'Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.\n\nIndividualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms.'}, {'id': 'BG001', 'title': 'Fluoxetine', 'description': 'Selective serotonin reuptake inhibitor.\n\nFluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Fluoxetine placebo plus individualized homeopathic placebo\n\nPlacebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49', 'spread': '6.4', 'groupId': 'BG000'}, {'value': '49.2', 'spread': '5.3', 'groupId': 'BG001'}, {'value': '48.8', 'spread': '5.8', 'groupId': 'BG002'}, {'value': '49', 'spread': '5.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '133', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '133', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Mexico', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '133', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline score in 17-item Hamilton Rating Scale for Depression', 'classes': [{'categories': [{'measurements': [{'value': '21.2', 'spread': '2.7', 'groupId': 'BG000'}, {'value': '20.6', 'spread': '2.9', 'groupId': 'BG001'}, {'value': '20.7', 'spread': '3.1', 'groupId': 'BG002'}, {'value': '20.8', 'spread': '2.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'A total score in 17-item Hamilton Scale for Depression was assessed for this study. It ranges from 0 (no depression) up to 52 (most severe depression). A score \\< or = 7 is considered normal, 7 - 13 (mild depression), 14 - 24 (moderate to severe depression), \\> 24 (severe depression). The score of the 17 items was summed.\n\nThe score presented here is the baseline score of Hamilton Scale, the final score after the 6 weeks treatment is presented in Outcomes measure data table.', 'unitOfMeasure': 'Units in Hamilton Scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline score in Beck Depression Inventory', 'classes': [{'categories': [{'measurements': [{'value': '26.3', 'spread': '7.2', 'groupId': 'BG000'}, {'value': '25.0', 'spread': '7.8', 'groupId': 'BG001'}, {'value': '27.0', 'spread': '9.0', 'groupId': 'BG002'}, {'value': '26.1', 'spread': '8.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Beck Depression Inventory is a 21-question multiple-choice self-report inventory. For this study a total score range was assessed: 0 (without depression) up to 63 (most severe depression): 0 - 8 is considered normal, 9 - 18 (mild to moderate depression), 19 - 28 (moderate to severe depression), \\> 29 (severe depression). The score of the 21 questions was summed.\n\nThe score presented here is the baseline score of BDI, the final score after the 6 weeks treatment is presented in the Outcome measure data table.', 'unitOfMeasure': 'Units in Beck Depression Inventory', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline score in Greene Climacteric Scale', 'classes': [{'categories': [{'measurements': [{'value': '35.3', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '33.5', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '37.9', 'spread': '11.5', 'groupId': 'BG002'}, {'value': '35.5', 'spread': '10.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Greene Climacteric Scale is intended to be a standard measure of core climacteric symptoms. For this study a total range was assessed: 0 (without climacteric symptoms) up to 63 (most severe climacteric symptoms). The scale measures four separate sub-scales (anxiety, depression, somatic symptoms and sexual function). The score of the four sub-scales was summed. A total score of 0 -10 is considered without symptoms, 11 - 29 (mild symptoms), 30 - 49 (moderate symptoms) and \\> 50 (severe symptoms).\n\nThe score presented here is the baseline score of Greene Climacteric Scale before treatment.', 'unitOfMeasure': 'Units in Greene Climacteric Scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All patientes under randomization were included in the primary efficacy population (intention-to-treat population).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-30', 'studyFirstSubmitDate': '2012-06-30', 'resultsFirstSubmitDate': '2014-09-08', 'studyFirstSubmitQcDate': '2012-07-03', 'lastUpdatePostDateStruct': {'date': '2014-10-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-09-21', 'studyFirstPostDateStruct': {'date': '2012-07-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in 17-item Hamilton Rating Scale for Depression at 6 Weeks.', 'timeFrame': 'Baseline and 6 weeks', 'description': '17-item Hamilton Rating Scale for Depression (HRSD) is a well-known standardized scale used worldwide to assess severity of depression. Score ranges from 0 (no depression) up to 52 (maximum depression severity). A total score in HRSD was assessed at baseline and after six weeks of treatment. For this study the change was calculated as the later time point (total score in 17- HRSD at 6 weeks) minus the earlier time point (total score at baseline). A score \\< or = 7 is considered normal, 7 - 13 (mild depression), 14 - 24 (moderate to severe depression), \\> 24 (severe depression).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Beck Depression Inventory at 6 Weeks.', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Beck Depression Inventory (BDI) is a 21-question multiple-choice self-report inventory that assess severity of depression. A total score range was assessed at baseline and after six weeks of treatment. A score 0 (without depression) up to 63 (most severe depression). For this study the change was calculated as the later time point (total score in BDI at 6 weeks) minus the earlier time point (total score in BDI at baseline). A score 0 - 8 is considered normal, 9 - 18 (mild to moderate depression), 19 - 28 (moderate to severe depression), \\> 29 (severe depression).'}, {'measure': 'Responder Rates at 6 Weeks.', 'timeFrame': '6 weeks', 'description': '17-item Hamilton Rating Scale for Depression is a well-known standardized scale used worldwide to assess severity of depression. Score ranges from 0 (no depression) up to 52 (maximum depression severity). A total score in 17-item Hamilton Scale for Depression was assessed for this study. It ranges from 0 (no depression) up to 52 (most severe depression). A score \\< or = 7 is considered normal, 7 - 13 (mild depression), 14 - 24 (moderate to severe depression), \\> 24 (severe depression). Responder rate definition: a decrease of 50% or more from baseline score using 17-item Hamilton Rating Scale for Depression after six weeks treatment.'}, {'measure': 'Change From Baseline in Greene´s Scale at 6 Weeks.', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Greene Climacteric Scale (GS) is intended to be a standard measure of core climacteric symptoms. For this study a total range was assessed at baseline and after six weeks of treatment. A total score 0 (without climacteric symptoms) up to 63 (most severe climacteric symptoms). The change was calculated as the later time point (total score in GS at 6 weeks) minus the earlier time point (total score at baseline).The scale measures four separate sub-scales (anxiety, depression, somatic symptoms and sexual function). The score of the four sub-scales was summed. A total score of 0 -10 is considered without symptoms, 11 - 29 (mild symptoms), 30 - 49 (moderate symptoms) and \\> 50 (severe symptoms).'}, {'measure': 'Remission Rates at 6 Weeks', 'timeFrame': '6 weeks', 'description': '17-item Hamilton Rating Scale for Depression is a well-known standardized scale used worldwide to assess severity of depression. Score ranges from 0 (no depression) up to 52 (maximum depression severity). A total score in 17-item Hamilton Scale for Depression was assessed for this study. It ranges from 0 (no depression) up to 52 (most severe depression). A score \\< or = 7 is considered normal, 7 - 13 (mild depression), 14 - 24 (moderate to severe depression), \\> 24 (severe depression). Remission rate definition: 17-item Hamilton Rating Scale for Depression score \\< 7 points after 6 weeks of treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Depression', 'Perimenopause', 'Postmenopause', 'Homeopathy'], 'conditions': ['Moderate Depression', 'Menopausal and Postmenopausal Disorders']}, 'referencesModule': {'references': [{'pmid': '19687192', 'type': 'BACKGROUND', 'citation': 'Adler UC, Paiva NM, Cesar AT, Adler MS, Molina A, Padula AE, Calil HM. Homeopathic Individualized Q-Potencies versus Fluoxetine for Moderate to Severe Depression: Double-Blind, Randomized Non-Inferiority Trial. Evid Based Complement Alternat Med. 2011;2011:520182. doi: 10.1093/ecam/nep114. Epub 2011 Jun 8.'}, {'pmid': '1929776', 'type': 'BACKGROUND', 'citation': 'Frank E, Prien RF, Jarrett RB, Keller MB, Kupfer DJ, Lavori PW, Rush AJ, Weissman MM. Conceptualization and rationale for consensus definitions of terms in major depressive disorder. Remission, recovery, relapse, and recurrence. Arch Gen Psychiatry. 1991 Sep;48(9):851-5. doi: 10.1001/archpsyc.1991.01810330075011.'}, {'pmid': '17550960', 'type': 'BACKGROUND', 'citation': 'Hale GE, Zhao X, Hughes CL, Burger HG, Robertson DM, Fraser IS. Endocrine features of menstrual cycles in middle and late reproductive age and the menopausal transition classified according to the Staging of Reproductive Aging Workshop (STRAW) staging system. J Clin Endocrinol Metab. 2007 Aug;92(8):3060-7. doi: 10.1210/jc.2007-0066. Epub 2007 Jun 5.'}, {'pmid': '18303940', 'type': 'BACKGROUND', 'citation': 'Kirsch I, Deacon BJ, Huedo-Medina TB, Scoboria A, Moore TJ, Johnson BT. Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. PLoS Med. 2008 Feb;5(2):e45. doi: 10.1371/journal.pmed.0050045.'}, {'pmid': '12813115', 'type': 'BACKGROUND', 'citation': 'Kessler RC, Berglund P, Demler O, Jin R, Koretz D, Merikangas KR, Rush AJ, Walters EE, Wang PS; National Comorbidity Survey Replication. The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R). JAMA. 2003 Jun 18;289(23):3095-105. doi: 10.1001/jama.289.23.3095.'}, {'pmid': '8966556', 'type': 'BACKGROUND', 'citation': 'Murray CJ, Lopez AD. Evidence-based health policy--lessons from the Global Burden of Disease Study. Science. 1996 Nov 1;274(5288):740-3. doi: 10.1126/science.274.5288.740. No abstract available.'}, {'pmid': '8270583', 'type': 'BACKGROUND', 'citation': 'Greenberg PE, Stiglin LE, Finkelstein SN, Berndt ER. The economic burden of depression in 1990. J Clin Psychiatry. 1993 Nov;54(11):405-18.'}, {'pmid': '21208417', 'type': 'BACKGROUND', 'citation': 'Williams LM, Rush AJ, Koslow SH, Wisniewski SR, Cooper NJ, Nemeroff CB, Schatzberg AF, Gordon E. International Study to Predict Optimized Treatment for Depression (iSPOT-D), a randomized clinical trial: rationale and protocol. Trials. 2011 Jan 5;12:4. doi: 10.1186/1745-6215-12-4.'}, {'pmid': '7575105', 'type': 'BACKGROUND', 'citation': 'Simon GE, VonKorff M, Barlow W. Health care costs of primary care patients with recognized depression. Arch Gen Psychiatry. 1995 Oct;52(10):850-6. doi: 10.1001/archpsyc.1995.03950220060012.'}, {'pmid': '16585467', 'type': 'BACKGROUND', 'citation': 'Cohen LS, Soares CN, Vitonis AF, Otto MW, Harlow BL. Risk for new onset of depression during the menopausal transition: the Harvard study of moods and cycles. Arch Gen Psychiatry. 2006 Apr;63(4):385-90. doi: 10.1001/archpsyc.63.4.385.'}, {'pmid': '16585466', 'type': 'BACKGROUND', 'citation': 'Freeman EW, Sammel MD, Lin H, Nelson DB. Associations of hormones and menopausal status with depressed mood in women with no history of depression. Arch Gen Psychiatry. 2006 Apr;63(4):375-82. doi: 10.1001/archpsyc.63.4.375.'}, {'pmid': '14706945', 'type': 'BACKGROUND', 'citation': 'Freeman EW, Sammel MD, Liu L, Gracia CR, Nelson DB, Hollander L. Hormones and menopausal status as predictors of depression in women in transition to menopause. Arch Gen Psychiatry. 2004 Jan;61(1):62-70. doi: 10.1001/archpsyc.61.1.62.'}, {'pmid': '17306645', 'type': 'BACKGROUND', 'citation': 'Rapkin AJ. Vasomotor symptoms in menopause: physiologic condition and central nervous system approaches to treatment. Am J Obstet Gynecol. 2007 Feb;196(2):97-106. doi: 10.1016/j.ajog.2006.05.056.'}, {'pmid': '8827185', 'type': 'BACKGROUND', 'citation': 'Fava M, Davidson KG. Definition and epidemiology of treatment-resistant depression. Psychiatr Clin North Am. 1996 Jun;19(2):179-200. doi: 10.1016/s0193-953x(05)70283-5.'}, {'pmid': '21733480', 'type': 'BACKGROUND', 'citation': 'Davidson JR, Crawford C, Ives JA, Jonas WB. Homeopathic treatments in psychiatry: a systematic review of randomized placebo-controlled studies. J Clin Psychiatry. 2011 Jun;72(6):795-805. doi: 10.4088/JCP.10r06580.'}, {'pmid': '21320338', 'type': 'BACKGROUND', 'citation': 'Adler UC, Kruger S, Teut M, Ludtke R, Bartsch I, Schutzler L, Melcher F, Willich SN, Linde K, Witt CM. Homeopathy for depression--DEP-HOM: study protocol for a randomized, partially double-blind, placebo controlled, four armed study. Trials. 2011 Feb 14;12:43. doi: 10.1186/1745-6215-12-43.'}, {'pmid': '20573327', 'type': 'BACKGROUND', 'citation': 'Freeman MP, Mischoulon D, Tedeschini E, Goodness T, Cohen LS, Fava M, Papakostas GI. Complementary and alternative medicine for major depressive disorder: a meta-analysis of patient characteristics, placebo-response rates, and treatment outcomes relative to standard antidepressants. J Clin Psychiatry. 2010 Jun;71(6):682-8. doi: 10.4088/JCP.10r05976blu.'}, {'pmid': '9884175', 'type': 'BACKGROUND', 'citation': 'Linde K, Melchart D. Randomized controlled trials of individualized homeopathy: a state-of-the-art review. J Altern Complement Med. 1998 Winter;4(4):371-88. doi: 10.1089/acm.1998.4.371.'}, {'pmid': '17101037', 'type': 'BACKGROUND', 'citation': "Thompson TD, Weiss M. Homeopathy--what are the active ingredients? An exploratory study using the UK Medical Research Council's framework for the evaluation of complex interventions. BMC Complement Altern Med. 2006 Nov 13;6:37. doi: 10.1186/1472-6882-6-37."}, {'pmid': '17200612', 'type': 'BACKGROUND', 'citation': 'Dean ME, Coulter MK, Fisher P, Jobst K, Walach H; Delphi Panel of the CONSORT Group. Reporting data on homeopathic treatments (RedHot): a supplement to CONSORT*. Forsch Komplementmed. 2006 Dec;13(6):368-71. doi: 10.1159/000097073. Epub 2006 Dec 21.'}, {'pmid': '21686296', 'type': 'BACKGROUND', 'citation': 'Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomized trials. Open Med. 2010;4(1):e60-8. Epub 2010 Mar 24. No abstract available.'}, {'pmid': '18834714', 'type': 'BACKGROUND', 'citation': 'Ludtke R, Rutten ALB. The conclusions on the effectiveness of homeopathy highly depend on the set of analyzed trials. J Clin Epidemiol. 2008 Dec;61(12):1197-1204. doi: 10.1016/j.jclinepi.2008.06.015. Epub 2008 Oct 1.'}, {'pmid': '18194760', 'type': 'BACKGROUND', 'citation': 'Bordet MF, Colas A, Marijnen P, Masson J, Trichard M. Treating hot flushes in menopausal women with homeopathic treatment--results of an observational study. Homeopathy. 2008 Jan;97(1):10-5. doi: 10.1016/j.homp.2007.11.005.'}, {'pmid': '16125589', 'type': 'BACKGROUND', 'citation': 'Shang A, Huwiler-Muntener K, Nartey L, Juni P, Dorig S, Sterne JA, Pewsner D, Egger M. Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy. Lancet. 2005 Aug 27-Sep 2;366(9487):726-32. doi: 10.1016/S0140-6736(05)67177-2.'}, {'pmid': '11059441', 'type': 'BACKGROUND', 'citation': 'Mulrow CD, Williams JW Jr, Chiquette E, Aguilar C, Hitchcock-Noel P, Lee S, Cornell J, Stamm K. Efficacy of newer medications for treating depression in primary care patients. Am J Med. 2000 Jan;108(1):54-64. doi: 10.1016/s0002-9343(99)00316-2.'}, {'pmid': '15353006', 'type': 'BACKGROUND', 'citation': 'Dawson MY, Michalak EE, Waraich P, Anderson JE, Lam RW. Is remission of depressive symptoms in primary care a realistic goal? A meta-analysis. BMC Fam Pract. 2004 Sep 7;5:19. doi: 10.1186/1471-2296-5-19.'}, {'pmid': '29871025', 'type': 'DERIVED', 'citation': 'Macias-Cortes EDC, Llanes-Gonzalez L, Aguilar-Faisal L, Asbun-Bojalil J. Response to Individualized Homeopathic Treatment for Depression in Climacteric Women with History of Domestic Violence, Marital Dissatisfaction or Sexual Abuse: Results from the HOMDEP-MENOP Study. Homeopathy. 2018 Aug;107(3):202-208. doi: 10.1055/s-0038-1654709. Epub 2018 Jun 5.'}, {'pmid': '28325221', 'type': 'DERIVED', 'citation': 'Macias-Cortes ED, Llanes-Gonzalez L, Aguilar-Faisal L, Asbun-Bojalil J. Is metabolic dysregulation associated with antidepressant response in depressed women in climacteric treated with individualized homeopathic medicines or fluoxetine? The HOMDEP-MENOP Study. Homeopathy. 2017 Feb;106(1):3-10. doi: 10.1016/j.homp.2016.11.002. Epub 2017 Jan 10.'}, {'pmid': '25768800', 'type': 'DERIVED', 'citation': 'Macias-Cortes Edel C, Llanes-Gonzalez L, Aguilar-Faisal L, Asbun-Bojalil J. Individualized homeopathic treatment and fluoxetine for moderate to severe depression in peri- and postmenopausal women (HOMDEP-MENOP study): a randomized, double-dummy, double-blind, placebo-controlled trial. PLoS One. 2015 Mar 13;10(3):e0118440. doi: 10.1371/journal.pone.0118440. eCollection 2015.', 'retractions': [{'pmid': '32324840', 'source': 'PLoS One. 2020 Apr 23;15(4):e0232415'}]}, {'pmid': '23782520', 'type': 'DERIVED', 'citation': 'Macias-Cortes Edel C, Aguilar-Faisal L, Asbun-Bojalil J. Efficacy of individualized homeopathic treatment and fluoxetine for moderate to severe depression in peri- and postmenopausal women (HOMDEP-MENOP): study protocol for a randomized, double-dummy, double-blind, placebo-controlled trial. Trials. 2013 Apr 23;14:105. doi: 10.1186/1745-6215-14-105.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to determine whether individualized homeopathic treatment and fluoxetine are more efficient than placebo for moderate to severe depression in peri- and postmenopausal women.', 'detailedDescription': 'Perimenopausal period is characterized by an increased risk of depressive symptoms. Major depression is one of the most disabling medical conditions worldwide. At present, it is becoming more difficult to prove that antidepressants actually work better than placebo in clinical trials.Use of homeopathy to treat depression is widespread, but there is a lack of clinical trails about its efficacy in depression in peri- and postmenopausal women. Previous trials suggest that individualized homeopathic treatments improve depression in general population. The purpose of this study was to determine whether individualized homeopathic treatment and fluoxetine are more efficient than placebo for moderate depression in peri- and postmenopausal women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major depression according to DSM-IV\n* Moderate to severe depression according to 17-item Hamilton Rating Scale for Depression (14-24 score)\n* No current use of homeopathic treatment for depression or antidepressants or anxiolytic drugs 3 months prior to study entry\n* Not be currently taking psychotherapy for at least 3 months before study entry\n* Early transition to menopause defined by a change in cycle length of 7 days or longer in either direction from the participant´s own baseline for at least 2 cycles\n* Late transition to menopause defined as 3 to 11 months of amenorrhea\n* Postmenopausal stage defined by 12 months or more of amenorrhea\n* Capability and willingness to give informed consent and to comply with the study procedures\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Other psychiatric disorders different from moderate to severe depression (severe depression, schizophrenia, psychotic disorders, bipolar affective disorders, suicide attempt)\n* Alcohol or other substance abuse\n* Known allergy to fluoxetine\n* Cancer or hepatic diseases'}, 'identificationModule': {'nctId': 'NCT01635218', 'acronym': 'HOMDEP-MENOP', 'briefTitle': 'Homeopathic Treatment for Depression in Peri- and Postmenopausal Women', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hospital Juarez de Mexico'}, 'officialTitle': 'Efficacy of Individualized Homeopathic Treatment for Moderate to Severe Depression in Peri- and Postmenopausal Women: a Randomized Placebo-controlled, Double-blind, Double-dummy, Study Protocol', 'orgStudyIdInfo': {'id': 'HJM2030/12-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Individualized homeopathic treatment', 'description': 'Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.', 'interventionNames': ['Drug: Individualized homeopathic treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Fluoxetine', 'description': 'Selective serotonin reuptake inhibitor.', 'interventionNames': ['Drug: Fluoxetine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Fluoxetine placebo plus individualized homeopathic placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Individualized homeopathic treatment', 'type': 'DRUG', 'otherNames': ['Homeopathic remedies', 'Homeopathic medicines'], 'description': 'A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms.', 'armGroupLabels': ['Individualized homeopathic treatment']}, {'name': 'Fluoxetine', 'type': 'DRUG', 'otherNames': ['Prozac'], 'description': '20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4.', 'armGroupLabels': ['Fluoxetine']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Fluoxetine placebo', 'Individualized homeopathic placebo'], 'description': 'Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07760', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Hospital Juárez de México', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Emma del Carmen Macías-Cortés, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Juárez de México'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Juarez de Mexico', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Emma del Carmen Macías-Cortés, MD, PhD', 'investigatorAffiliation': 'Hospital Juarez de Mexico'}}}}