Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-25 @ 7:39 PM
Study NCT ID:
NCT01368432
Status:
COMPLETED
Last Update Posted:
2016-10-24
First Post:
2011-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Lexapro for the Treatment of Traumatic Brain Injury (TBI) Depression & Other Psychiatric Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001519', 'term': 'Behavior'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000089983', 'term': 'Escitalopram'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vrao@jhmi.edu', 'phone': '410-550-2288', 'title': 'Vani Rao', 'organization': 'Johns Hopkins University & school of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Through study completion', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Escitalopram', 'description': 'Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week.', 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group Baseline', 'description': 'The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.'}, {'id': 'OG001', 'title': 'Treatment Group Baseline', 'description': 'Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.5', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '33.6', 'spread': '6.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'MADRS score at baseline', 'description': 'This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess the difference in Montgomery-Asberg Depression Rating Scale (MADRS) at baseline and 12 weeks. The scores range from 0-60.\n\n0 to 6 - normal; 7 to 19 - mild depression; 20 to 34 - moderate depression; \\>34 - severe depression.\n\nIn this study the score was used as a continuous variable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Montgomery-Asberg Depression Rating Scale (MADRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group MADRS 12 Weeks', 'description': 'This group consists of participants who received the placebo intervention and their level of depression as assessed by the MADRS scoring system.'}, {'id': 'OG001', 'title': 'Treatment Group MADRS 12 Weeks', 'description': 'This group consists of participants who received escitalopram and their level of depression as assessed by the MADRS scoring system.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.2', 'spread': '9.5', 'groupId': 'OG000'}, {'value': '7', 'spread': '5.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'MADRS score at 12 weeks', 'description': 'This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess the difference in Montgomery-Asberg Depression Rating Scale (MADRS) at baseline and 12 weeks. The scores range from 0-60.\n\n0 to 6 - normal; 7 to 19 - mild depression; 20 to 34 - moderate depression; \\>34 - severe depression.\n\nIn this study the score was used as a continuous variable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression (CGI) - Severity at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group Baseline', 'description': 'This group consists of participants who received the placebo intervention and represents their baseline global health.'}, {'id': 'OG001', 'title': 'Treatment Group Baseline', 'description': 'This group consists of participants who received escitalopram and represents their baseline global health'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "This outcome measure is assessing the participant's overall psychiatric health based upon the CGI score as assessed by the investigator. Scores range from 1-7\n\n1. = Normal-not at all ill\n2. = Borderline mentally ill\n3. = Mildly ill\n4. = Moderately ill\n5. = Markedly ill\n6. = Severely ill\n7. = Among the most extremely ill patients.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression (CGI)- Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group 12 Weeks', 'description': 'This group consists of participants who received the placebo intervention and represents their global health score at 12 weeks'}, {'id': 'OG001', 'title': 'Treatment Group 12 Weeks', 'description': 'This group consists of participants who received escitalopram and represents their global health at 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 12 weeks', 'description': "This outcome measure is assessing the participant's overall psychiatric health based upon the CGI score as assessed by the investigator.\n\nThe scores range from 1-7\n\n1. = Very much improved\n2. = Much improved\n3. = Minimally improved\n4. = No change\n5. = Minimally worse\n6. = Much worse\n7. = Very much worse", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Anxiety Scale (CAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group Baseline', 'description': 'This group consists of participants who received the placebo intervention and represents their anxiety score.'}, {'id': 'OG001', 'title': 'Treatment Group Baseline', 'description': 'This group consists of participants who received escitalopram intervention and represents their anxiety score.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '14.8', 'spread': '6.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "This outcome measure is assessing the participant's anxiety as assessed by the CAS.\n\nThe scores range from 0( normal; no anxiety) to 21 ( severe anxiety). It is used as a continuous variable.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Anxiety Scale (CAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group 12 Weeks', 'description': 'This group consists of participants who received the placebo intervention and represents their anxiety score.'}, {'id': 'OG001', 'title': 'Treatment Group 12 Weeks', 'description': 'This group consists of participants who received escitalopram intervention and represents their anxiety score.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': "This outcome measure is assessing the participant's anxiety as assessed by the CAS.\n\nThe scores range from 0( normal; no anxiety) to 21 ( severe anxiety). It is used as a continuous variable.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Satisfaction With Life (SWL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group Baseline', 'description': 'This group consists of participants who received the placebo intervention.'}, {'id': 'OG001', 'title': 'Treatment Group Baseline', 'description': 'This group consists of participants who received escitalopram intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.8', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '15.6', 'spread': '9.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'This outcome measure asses the participants overall satisfaction with life as measured by the SWL scale.\n\nThe scores range from 5 ( absolutely no satisfaction ) to 35 ( very satisfied with life).\n\nIt is used as continuous variable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Satisfaction With Life (SWL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group 12 Weeks', 'description': 'This group consists of participants who received the placebo intervention.'}, {'id': 'OG001', 'title': 'Treatment Group 12 Weeks', 'description': 'This group consists of participants who received escitalopram intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.2', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '22.6', 'spread': '5.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'This outcome measure asses the participants overall satisfaction with life as measured by the SWL scale.\n\nThe scores range from 5 ( absolutely no satisfaction ) to 35 ( very satisfied with life).\n\nIt is used as continuous variable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life (QWL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group Baseline', 'description': 'This group consists of participants who received the placebo intervention.'}, {'id': 'OG001', 'title': 'Treatment Group Baseline', 'description': 'This group consists of participants who received escitalopram intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.8', 'spread': '22.3', 'groupId': 'OG000'}, {'value': '64.1', 'spread': '24.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline', 'description': 'This outcome measure is assessing the participants impression of their quality of life as measured by the QWL scale.\n\nScores range from 16 ( terrible quality of life ) to 112 (Very delighted). Used as a continuous variable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life (QWL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group 12 Weeks', 'description': 'This group consists of participants who received the placebo intervention.'}, {'id': 'OG001', 'title': 'Treatment Group 12 Weeks', 'description': 'This group consists of participants who received escitalopram intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.2', 'spread': '30.3', 'groupId': 'OG000'}, {'value': '78.7', 'spread': '17.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 12 weeks', 'description': 'This outcome measure is assessing the participants impression of their quality of life as measured by the QWL scale.\n\nScores range from 16 ( terrible quality of life ) to 112 (Very delighted). Used as a continuous variable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Disability Rating Scale (DRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group Baseline', 'description': 'This group consists of participants who received the placebo intervention.'}, {'id': 'OG001', 'title': 'Treatment Group Baseline', 'description': 'This group consists of participants who received escitalopram intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline', 'description': 'This scale is a measure of impairment, disability and handicap. It is intended to measure accurately general functional changes over the course of recovery and has found to be both valid and reliable.\n\nScores range from 0 (normal) and 29 (extreme vegetative state).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Disability Rating Scale (DRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group 12 Weeks', 'description': 'This group consists of participants who received the placebo intervention.'}, {'id': 'OG001', 'title': 'Treatment Group 12 Weeks', 'description': 'This group consists of participants who received escitalopram intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '1', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 12 weeks', 'description': 'This scale is a measure of impairment, disability and handicap. It is intended to measure accurately general functional changes over the course of recovery and has found to be both valid and reliable.\n\nScores range from 0 (normal) and 29 (extreme vegetative state).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mini Mental Status Exam (MMSE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group Baseline', 'description': 'This group consists of participants who received the placebo intervention.'}, {'id': 'OG001', 'title': 'Treatment Group Baseline', 'description': 'This group consists of participants who received escitalopram intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.3', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '27.1', 'spread': '1.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline', 'description': 'This outcome measure assess the participants Cognitive status. Scores range from 0 ( significantly impaired) -30 ( normal).\n\nA score of 23 or lower is indicative of cognitive impairment. In this study the score was used as a continuous variable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mini Mental Status Exam (MMSE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group 12 Weeks', 'description': 'This group consists of participants who received the placebo intervention.'}, {'id': 'OG001', 'title': 'Treatment Group 12 Weeks', 'description': 'This group consists of participants who received escitalopram intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.7', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '29.0', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 12 weeks', 'description': 'This outcome measure assess the participants Cognitive status. Scores range from 0 ( significantly impaired) -30 ( normal).\n\nA score of 23 or lower is indicative of cognitive impairment. In this study the score was used as a continuous variable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.'}, {'id': 'FG001', 'title': 'Escitalopram', 'description': 'Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects were recruited from the Brain injury clinic at Johns Hopkins Bayview Medical Center, other Johns Hopkins outpatient clinics, and via advertisements in local papers.', 'preAssignmentDetails': 'One admitted to active alcohol abuse before initiating medications , and therefore no longer met inclusion criteria. Another consented but failed to return for any follow-up visits.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.'}, {'id': 'BG001', 'title': 'Escitalopram', 'description': 'Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, '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': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-31', 'studyFirstSubmitDate': '2011-06-03', 'resultsFirstSubmitDate': '2016-07-13', 'studyFirstSubmitQcDate': '2011-06-07', 'lastUpdatePostDateStruct': {'date': '2016-10-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-08-31', 'studyFirstPostDateStruct': {'date': '2011-06-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline', 'timeFrame': 'MADRS score at baseline', 'description': 'This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess the difference in Montgomery-Asberg Depression Rating Scale (MADRS) at baseline and 12 weeks. The scores range from 0-60.\n\n0 to 6 - normal; 7 to 19 - mild depression; 20 to 34 - moderate depression; \\>34 - severe depression.\n\nIn this study the score was used as a continuous variable.'}, {'measure': 'Montgomery-Asberg Depression Rating Scale (MADRS)', 'timeFrame': 'MADRS score at 12 weeks', 'description': 'This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess the difference in Montgomery-Asberg Depression Rating Scale (MADRS) at baseline and 12 weeks. The scores range from 0-60.\n\n0 to 6 - normal; 7 to 19 - mild depression; 20 to 34 - moderate depression; \\>34 - severe depression.\n\nIn this study the score was used as a continuous variable.'}], 'secondaryOutcomes': [{'measure': 'Clinical Global Impression (CGI) - Severity at Baseline', 'timeFrame': 'Baseline', 'description': "This outcome measure is assessing the participant's overall psychiatric health based upon the CGI score as assessed by the investigator. Scores range from 1-7\n\n1. = Normal-not at all ill\n2. = Borderline mentally ill\n3. = Mildly ill\n4. = Moderately ill\n5. = Markedly ill\n6. = Severely ill\n7. = Among the most extremely ill patients."}, {'measure': 'Clinical Global Impression (CGI)- Improvement', 'timeFrame': 'at 12 weeks', 'description': "This outcome measure is assessing the participant's overall psychiatric health based upon the CGI score as assessed by the investigator.\n\nThe scores range from 1-7\n\n1. = Very much improved\n2. = Much improved\n3. = Minimally improved\n4. = No change\n5. = Minimally worse\n6. = Much worse\n7. = Very much worse"}, {'measure': 'Clinical Anxiety Scale (CAS)', 'timeFrame': 'Baseline', 'description': "This outcome measure is assessing the participant's anxiety as assessed by the CAS.\n\nThe scores range from 0( normal; no anxiety) to 21 ( severe anxiety). It is used as a continuous variable."}, {'measure': 'Clinical Anxiety Scale (CAS)', 'timeFrame': '12 weeks', 'description': "This outcome measure is assessing the participant's anxiety as assessed by the CAS.\n\nThe scores range from 0( normal; no anxiety) to 21 ( severe anxiety). It is used as a continuous variable."}, {'measure': 'Satisfaction With Life (SWL)', 'timeFrame': 'baseline', 'description': 'This outcome measure asses the participants overall satisfaction with life as measured by the SWL scale.\n\nThe scores range from 5 ( absolutely no satisfaction ) to 35 ( very satisfied with life).\n\nIt is used as continuous variable.'}, {'measure': 'Satisfaction With Life (SWL)', 'timeFrame': '12 weeks', 'description': 'This outcome measure asses the participants overall satisfaction with life as measured by the SWL scale.\n\nThe scores range from 5 ( absolutely no satisfaction ) to 35 ( very satisfied with life).\n\nIt is used as continuous variable.'}, {'measure': 'Quality of Life (QWL)', 'timeFrame': 'At baseline', 'description': 'This outcome measure is assessing the participants impression of their quality of life as measured by the QWL scale.\n\nScores range from 16 ( terrible quality of life ) to 112 (Very delighted). Used as a continuous variable.'}, {'measure': 'Quality of Life (QWL)', 'timeFrame': 'At 12 weeks', 'description': 'This outcome measure is assessing the participants impression of their quality of life as measured by the QWL scale.\n\nScores range from 16 ( terrible quality of life ) to 112 (Very delighted). Used as a continuous variable.'}, {'measure': 'Disability Rating Scale (DRS)', 'timeFrame': 'At baseline', 'description': 'This scale is a measure of impairment, disability and handicap. It is intended to measure accurately general functional changes over the course of recovery and has found to be both valid and reliable.\n\nScores range from 0 (normal) and 29 (extreme vegetative state).'}, {'measure': 'Disability Rating Scale (DRS)', 'timeFrame': 'At 12 weeks', 'description': 'This scale is a measure of impairment, disability and handicap. It is intended to measure accurately general functional changes over the course of recovery and has found to be both valid and reliable.\n\nScores range from 0 (normal) and 29 (extreme vegetative state).'}, {'measure': 'Mini Mental Status Exam (MMSE)', 'timeFrame': 'At baseline', 'description': 'This outcome measure assess the participants Cognitive status. Scores range from 0 ( significantly impaired) -30 ( normal).\n\nA score of 23 or lower is indicative of cognitive impairment. In this study the score was used as a continuous variable.'}, {'measure': 'Mini Mental Status Exam (MMSE)', 'timeFrame': 'At 12 weeks', 'description': 'This outcome measure assess the participants Cognitive status. Scores range from 0 ( significantly impaired) -30 ( normal).\n\nA score of 23 or lower is indicative of cognitive impairment. In this study the score was used as a continuous variable.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['TBI', 'Depression', 'Mood', 'Behavior'], 'conditions': ['TBI', 'Major Depression', 'Other Psychiatric Disorders']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.biamd.org', 'label': 'Brain Injury Association of Maryland'}]}, 'descriptionModule': {'briefSummary': 'This research is being done to see if a drug called escitalopram (Lexapro) is helpful to people who are suffering from depression after traumatic brain injury (TBI).', 'detailedDescription': "Despite it's high prevalence, little is known about the pharmacological treatment of depression following Traumatic Brain Injury (TBI). This is because of a lack of randomized controlled studies in the treatment of post-TBI depression. This study is designed to examine the safety and effectiveness of escitalopram in the treatment of post-TBI depression. It will also investigate metabolic changes and neural pathways associated with post-TBI depression and metabolic alterations after treatment through neuroimaging."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Closed head injury\n* Fulfill Diagnostic and Statistical Manual Diploma in Social Medicine (DSM) IV criteria "Major Depressive Disorder"\n* 18 years of age or older\n* Able to provide informed consent\n* Stable medical history\n\nExclusion Criteria:\n\n* History of Stroke, Encephalitis, Seizures, or any other pre-TBI neurological diseases\n* History of mental retardation\n* Alcohol or Substance dependence in the last 1 year\n* Inability to undergo MRI scan\n* Pregnancy\n* Current use of any psychotropic medications including any antidepressants, antipsychotics, anxiolytics, or sedative hypnotics\n* Poor response to escitalopram in the past\n* Acutely suicidal or requiring inpatient psychiatric hospitalization, as determined by the study psychiatrist\n* Good medication response to another antidepressant in the past'}, 'identificationModule': {'nctId': 'NCT01368432', 'briefTitle': 'Lexapro for the Treatment of Traumatic Brain Injury (TBI) Depression & Other Psychiatric Conditions', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Escitalopram (Lexapro) for the Treatment of TBI Depression and Other Comorbid Psychiatric Conditions', 'orgStudyIdInfo': {'id': 'NA_00020154'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Daily for 12 weeks', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Escitalopram', 'description': 'Escitalopram 10 mg or 20 mg daily for 12 weeks', 'interventionNames': ['Drug: Escitalopram']}], 'interventions': [{'name': 'Escitalopram', 'type': 'DRUG', 'otherNames': ['Lexapro'], 'description': 'Escitalopram 10 mg or 20 mg daily for 12 weeks by mouth', 'armGroupLabels': ['Escitalopram']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['sugar pill'], 'description': 'Sugar pill placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Vani Rao, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Forest Laboratories', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Vani Rao, MD', 'investigatorAffiliation': 'Johns Hopkins University'}}}}