Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT00245635
Status:
COMPLETED
Last Update Posted:
2018-04-27
First Post:
2005-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Fluoxetine in Pediatric Body Dysmorphic Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057215', 'term': 'Body Dysmorphic Disorders'}], 'ancestors': [{'id': 'D013001', 'term': 'Somatoform Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005473', 'term': 'Fluoxetine'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eholland@montefiore.org', 'phone': '7189204287', 'title': 'Eric Hollander, MD', 'organization': 'Montefiore Medical Center, Albert Einstein College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Event data was collected throughout the course of the study.', 'description': "Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.", 'eventGroups': [{'id': 'EG000', 'title': 'Fluoxetine', 'description': "Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.\n\nFluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score.", 'otherNumAtRisk': 25, 'otherNumAffected': 2, 'seriousNumAtRisk': 25, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': "Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.\n\nPlacebo: Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score.", 'otherNumAtRisk': 18, 'otherNumAffected': 3, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Trouble Sleeping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nightmares', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomach Pains', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sweating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Agitated/Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Silliness/Feeling too happy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lit Paper on Fire', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Emotional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Menstrual Cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Forgetfulness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Light hurts eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeling tense', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ears ringing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurred/double Vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Visit to ER: Family Conflict', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Visit to ER: Aches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itchiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leg Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hair Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Delay in Urination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Numbness', 'notes': 'Hands and feet.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tingling', 'notes': 'Hands and Feet', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart Pounding/Racing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Trouble Keeping Balance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Room Spinning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight Gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Suicidal Behavior', 'notes': 'Suicidal behavior was seen in one subject and had a possible relationship to study drug, and subject was seen in a partial hospitalization setting. This was reported to the IRB, FDA and DSMB.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Total Score on the BDD-Y-BOCS Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluoxetine', 'description': "Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.\n\nFluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.\n\nPlacebo: Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score."}], 'classes': [{'categories': [{'measurements': [{'value': '-12.27', 'spread': '11.78', 'groupId': 'OG000'}, {'value': '-9.53', 'spread': '12.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline compared to the study endpoint (week 12) [two time points]', 'description': "To assess the change in total score on the Body Dysmorphic Disorder-Yale-Brown Obsessive Compulsive Scale (BDD-Y-BOCS) from baseline (visit 0) to endpoint (week 12). This is a 12-item scale that assesses obsessions and compulsions related to the patient's BDD. Each item's score ranges from 0 to 4, with a total possible score of 48 on the full assessment. Scores of 0 indicate no impairment, while scores of 4 indicate maximum impairment. Thus higher scores are considered to be a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fluoxetine', 'description': "Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.\n\nFluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score."}, {'id': 'FG001', 'title': 'Placebo', 'description': "Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.\n\nPlacebo: Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fluoxetine', 'description': "Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.\n\nFluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score."}, {'id': 'BG001', 'title': 'Placebo', 'description': "Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.\n\nPlacebo: Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15.04', 'groupId': 'BG000', 'lowerLimit': '9', 'upperLimit': '18'}, {'value': '14.88', 'groupId': 'BG001', 'lowerLimit': '10', 'upperLimit': '18'}, {'value': '14.96', 'groupId': 'BG002', 'lowerLimit': '9', 'upperLimit': '18'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BDD-Y-BOCS', 'classes': [{'categories': [{'measurements': [{'value': '30.84', 'spread': '4.2', 'groupId': 'BG000'}, {'value': '35.16', 'spread': '5.10', 'groupId': 'BG001'}, {'value': '32.65', 'spread': '5.02', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Total scores at Baseline on the Body Dysmorphic Disorder-Yale-Brown Obsessive Compulsive Scale (BDD-Y-BOCS)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-30', 'studyFirstSubmitDate': '2005-10-26', 'resultsFirstSubmitDate': '2015-04-21', 'studyFirstSubmitQcDate': '2005-10-26', 'lastUpdatePostDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-06-09', 'studyFirstPostDateStruct': {'date': '2005-10-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Total Score on the BDD-Y-BOCS Scale', 'timeFrame': 'Baseline compared to the study endpoint (week 12) [two time points]', 'description': "To assess the change in total score on the Body Dysmorphic Disorder-Yale-Brown Obsessive Compulsive Scale (BDD-Y-BOCS) from baseline (visit 0) to endpoint (week 12). This is a 12-item scale that assesses obsessions and compulsions related to the patient's BDD. Each item's score ranges from 0 to 4, with a total possible score of 48 on the full assessment. Scores of 0 indicate no impairment, while scores of 4 indicate maximum impairment. Thus higher scores are considered to be a worse outcome."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Body Dysmorphic Disorder', 'BDD', 'BDD treatment', 'delusionality variant', 'OCD'], 'conditions': ['Body Dysmorphic Disorder']}, 'descriptionModule': {'briefSummary': 'This trial will study the effectiveness of the medication fluoxetine for children and adolescents ages 16 and younger with BDD who qualify.', 'detailedDescription': 'BDD usually begins in childhood or adolescence, but its treatment in pediatric populations has not been investigated. Recent data suggests that adults with BDD may respond to serotonin reuptake inhibitors (SRIs) such as fluoxetine (Prozac). Preliminary findings from case reports suggest that SRIs may also be effective in the treatment of BDD in children and adolescents. This study is the first large-scale, double-blind, placebo-controlled medication trial of fluoxetine for children and adolescents with BDD. Participants should be aged 16 or younger. Participation in this trial will last approximately 14 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female children and adolescents aged 16 and younger\n* BDD or its delusional variant present currently and for at least 6 months prior to the study\n* Ability to communicate meaningfully with the investigators and competent to provide written assent\n\nExclusion Criteria:\n\n* Presence of Schizophrenia or Bipolar Disorder\n* Recent suicide attempt or suicidal ideations that warrant hospitalizations\n* Previous allergic reaction to fluoxetine\n* History of a seizure disorder'}, 'identificationModule': {'nctId': 'NCT00245635', 'acronym': 'FDA BDD', 'briefTitle': 'Fluoxetine in Pediatric Body Dysmorphic Disorder', 'nctIdAliases': ['NCT00029471'], 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'Fluoxetine in Pediatric Body Dysmorphic Disorder', 'orgStudyIdInfo': {'id': '09-10-302'}, 'secondaryIdInfos': [{'id': '7R01FD002613-04', 'link': 'https://reporter.nih.gov/quickSearch/7R01FD002613-04', 'type': 'FDA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fluoxetine', 'description': 'Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.', 'interventionNames': ['Drug: Fluoxetine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Fluoxetine', 'type': 'DRUG', 'otherNames': ['Prozac'], 'description': "Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score.", 'armGroupLabels': ['Fluoxetine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': "Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score.", 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center, Albert Einstein College of Medicine', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Eric Hollander, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center/Albert Einstein College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Food and Drug Administration (FDA)', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Psychiatry & Behavioral Sciences', 'investigatorFullName': 'Eric Hollander', 'investigatorAffiliation': 'Montefiore Medical Center'}}}}