Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT00523705
Status:
TERMINATED
Last Update Posted:
2014-06-06
First Post:
2007-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011293', 'term': 'Premenstrual Syndrome'}], 'ancestors': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000089983', 'term': 'Escitalopram'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'freemane@mail.med.upenn.edu', 'phone': '215 662-3329', 'title': 'Ellen Freeman, Principal Investigator', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 treatment months', 'eventGroups': [{'id': 'EG000', 'title': 'Escitalopram', 'description': 'Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.', 'otherNumAtRisk': 7, 'otherNumAffected': 5, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sugar Pill', 'description': 'Placebo tablets matched to drug.', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'breast tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subject Daily Symptom Rating Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Escitalopram', 'description': 'Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.'}, {'id': 'OG001', 'title': 'Sugar Pill', 'description': 'Placebo tablets matched to drug.'}], 'classes': [{'title': 'mean score at baseline', 'categories': [{'measurements': [{'value': '155.6', 'spread': '55.3', 'groupId': 'OG000'}, {'value': '169', 'spread': '59.1', 'groupId': 'OG001'}]}]}, {'title': 'mean score at endpoint (5 months)', 'categories': [{'measurements': [{'value': '91.6', 'spread': '54.2', 'groupId': 'OG000'}, {'value': '121.3', 'spread': '131.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.467', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.57', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.86', 'estimateComment': 'estimate of main effect of treatment in a linear mixed effects model.', 'groupDescription': 'Pilot data were examined at treatment endpoint for change from baseline. Statistical power was very low due to the small sample size.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 5 months.', 'description': 'A daily diary with 17 symptoms of PMS rated on a 5-point scale to indicate none to very severe symptoms. Minimum score 0; maximum score 408.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sheehan Disability Scale (SDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Escitalopram', 'description': 'Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.'}, {'id': 'OG001', 'title': 'Sugar Pill', 'description': 'Placebo tablets matched to drug.'}], 'timeFrame': 'Throughout study', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not analyzed due to only 11 subjects.'}, {'type': 'SECONDARY', 'title': 'Patient Global Evaluation of Improvement (PGE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Escitalopram', 'description': 'Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.'}, {'id': 'OG001', 'title': 'Sugar Pill', 'description': 'Placebo tablets matched to drug.'}], 'timeFrame': 'Throughout treatment', 'reportingStatus': 'POSTED', 'populationDescription': 'Not analyzed due to small number of subjects'}, {'type': 'SECONDARY', 'title': 'Subject Satisfaction Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Escitalopram', 'description': 'Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.'}, {'id': 'OG001', 'title': 'Sugar Pill', 'description': 'Placebo tablets matched to drug.'}], 'timeFrame': 'Study endpoint', 'reportingStatus': 'POSTED', 'populationDescription': 'Not analyzed due to small number of subjects.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Escitalopram', 'description': 'Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.'}, {'id': 'FG001', 'title': 'Sugar Pill', 'description': 'Placebo tablets matched to drug.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'comment': '1 withdrew due to no time', 'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'No time for study.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The recruitment period was from 01/25/08 to 07/07/09. The study was conducted in an academic research unit. 54 females signed consent for the study at visit 1. 43 were ineligible during the screen period and 11 were randomized to double-blind treatment.', 'preAssignmentDetails': 'During the screen period of 2 menstrual cycles, subjects rated daily symptom diaries to indicate the presence and severity of premenstrual symptoms. A total premenstrual score \\>80 in each cycle was required for randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Escitalopram', 'description': 'Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.'}, {'id': 'BG001', 'title': 'Sugar Pill', 'description': 'Placebo tablets matched to drug.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '17.6', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '17.3', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '17.4', 'spread': '1.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'Enrollment too slow.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-29', 'studyFirstSubmitDate': '2007-08-30', 'resultsFirstSubmitDate': '2012-06-13', 'studyFirstSubmitQcDate': '2007-08-30', 'lastUpdatePostDateStruct': {'date': '2014-06-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-29', 'studyFirstPostDateStruct': {'date': '2007-08-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subject Daily Symptom Rating Score.', 'timeFrame': 'baseline and 5 months.', 'description': 'A daily diary with 17 symptoms of PMS rated on a 5-point scale to indicate none to very severe symptoms. Minimum score 0; maximum score 408.'}], 'secondaryOutcomes': [{'measure': 'Sheehan Disability Scale (SDS)', 'timeFrame': 'Throughout study'}, {'measure': 'Patient Global Evaluation of Improvement (PGE)', 'timeFrame': 'Throughout treatment'}, {'measure': 'Subject Satisfaction Questionnaire', 'timeFrame': 'Study endpoint'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['premenstrual syndrome', 'PMS', 'PMDD', 'treatment', 'SSRI'], 'conditions': ['PMS']}, 'referencesModule': {'references': [{'pmid': '17174829', 'type': 'BACKGROUND', 'citation': 'Vichnin M, Freeman EW, Lin H, Hillman J, Bui S. Premenstrual syndrome (PMS) in adolescents: severity and impairment. J Pediatr Adolesc Gynecol. 2006 Dec;19(6):397-402. doi: 10.1016/j.jpag.2006.06.015.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot study is to determine the efficacy and safety of escitalopram administered premenstrually (day 14 through day 2 of the menstrual cycle) for severe PMS in young women ages 15-19 years.', 'detailedDescription': 'The medication in this study is a serotonin reuptake inhibitor (SSRI), a class that is considered the first-line treatment for severe PMS at this time. Although data indicate that young women who have PMS in their teen years report the same symptoms and symptom severity as adult women, clinical trials have not included this age group, and there is no information on the efficacy and safety of treatment with a serotonergic antidepressant for PMS in teens.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Females 15-19 years of age\n* Regular menstrual cycles of 22-35 days\n* In general good health\n* Medically approved birth control method if sexually active\n* Evidence of ovulation\n* Meeting all symptom criteria for PMS\n* Signed informed consent\n* Subjects under age 18 must also have signed parental consent\n\nExclusion Criteria:\n\n* Current use of any treatment for PMS.\n* Psychotropic or other medications that may compromise the study drug.\n* Pregnancy, intending pregnancy or breast feeding.\n* Not using a medically approved birth control method if sexually active.\n* Significant medical or gynecological abnormalities.\n* Irregular menses, any gynecologic disorder.\n* Any severe or unstable medical illness.\n* Any current major psychiatric diagnosis or any history of a major psychiatric diagnosis.\n* Any current or history of alcohol abuse, drug abuse, suicide attempt, bi-polar disorder, psychosis or severe personality disorder.\n* Use of triptans (Imitrex, Zomig, Frova, Maxalt, Axert, Amerge, Relpax).\n* Use of medicines that include dextromethorphan such as Tylenol or Vicks cough medicines.\n* Use of the pain medication meperidine.\n* Use of any herbal product such as St John's Wort that may increase serotonin.\n* Use of monoamine oxidase inhibitors (MAOIs), pimozide or citalopram hydrobromide.\n* Drugs metabolized by CYP2D6 or a combination of CYP3A4 and CYP2D6 inhibitors.\n* Hypersensitivity to escitalopram or citalopram."}, 'identificationModule': {'nctId': 'NCT00523705', 'briefTitle': 'Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study', 'orgStudyIdInfo': {'id': '805778'}, 'secondaryIdInfos': [{'id': 'LXP-MD-123 (Forest Pharm)', 'type': 'OTHER', 'domain': 'Forest Research Institute'}, {'id': 'LXP-MD-123', 'type': 'OTHER', 'domain': 'Forest Research Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'escitalopram', 'description': 'Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.', 'interventionNames': ['Drug: escitalopram']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Placebo tablets matched to drug.', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'escitalopram', 'type': 'DRUG', 'otherNames': ['Lexapro'], 'description': '10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.', 'armGroupLabels': ['escitalopram']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'Placebo tablets matched to drug', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Dept OB/GYN, Mudd Professorship Suite', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Ellen Freeman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'Forest Laboratories', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}