Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-27 @ 1:41 AM
Study NCT ID:
NCT00389493
Status:
COMPLETED
Last Update Posted:
2014-04-25
First Post:
2006-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Risperidone or Cognitive-Behavioral Therapy for Improving Medication Treatment for Obsessive-compulsive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018967', 'term': 'Risperidone'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kimeldo@nyspi.columbia.edu', 'phone': '646-774-7000', 'title': 'Dr. Helen Blair Simpson', 'organization': 'New York State Psychiatric Institute'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treatment With Risperidone', 'description': 'Participants received treatment with risperidone Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated Mean Y-BOCS score measured at week 8', 'otherNumAtRisk': 40, 'otherNumAffected': 30, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment With Exposure/Response Prevention', 'description': 'Participants received exposure and response prevention therapy\n\nExposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.\n\nMean Y-BOCS score measured at week 8', 'otherNumAtRisk': 40, 'otherNumAffected': 22, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Treatment With Pill Placebo', 'description': 'Participants received treatment with the placebo\n\nPlacebo : Placebo capsules will be identical in appearance to those of risperidone.\n\nMean Y-BOCS score measured at week 8', 'otherNumAtRisk': 20, 'otherNumAffected': 13, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Sweating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Lightheadedness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Blurry Vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Eye disorders'}, {'term': 'Decreased Libido', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Anorgasmia/Erectile Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Impaired Coordination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 4}], 'organSystem': 'Nervous system disorders'}, {'term': 'Nervousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 4}], 'organSystem': 'Nervous system disorders'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 3}], 'organSystem': 'Nervous system disorders'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 3}], 'organSystem': 'Nervous system disorders'}, {'term': 'Weight Gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Weight Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Urinary Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Changes in breasts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Increased thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 4}], 'organSystem': 'Nervous system disorders'}, {'term': 'Extrapyramidal symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Risperidone', 'description': 'Participants received treatment with risperidone Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated Mean Y-BOCS score measured at week 8'}, {'id': 'OG001', 'title': 'Treatment With Exposure/Response Prevention', 'description': 'Participants received exposure and response prevention therapy\n\nExposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.\n\nMean Y-BOCS score measured at week 8'}, {'id': 'OG002', 'title': 'Treatment With Pill Placebo', 'description': 'Participants received treatment with the placebo\n\nPlacebo : Placebo capsules will be identical in appearance to those of risperidone.\n\nMean Y-BOCS score measured at week 8'}], 'classes': [{'title': 'Y-BOCS score at Week 0', 'categories': [{'measurements': [{'value': '26.1', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '27.2', 'spread': '3.9', 'groupId': 'OG001'}, {'value': '25.9', 'spread': '4.6', 'groupId': 'OG002'}]}]}, {'title': 'Y-BOCS score at Week 8', 'categories': [{'measurements': [{'value': '22.6', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '13.0', 'spread': '6.1', 'groupId': 'OG001'}, {'value': '23.1', 'spread': '6.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 and Week 8', 'description': 'Y-BOCS ranges from 0-40, with 0 meaning no symptoms and higher numbers meaning greater symptom severity', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Social Adjustment Scale-SR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Risperidone', 'description': 'Participants received treatment with risperidone Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated Mean Y-BOCS score measured at week 8'}, {'id': 'OG001', 'title': 'Treatment With Exposure/Response Prevention', 'description': 'Participants received exposure and response prevention therapy\n\nExposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.\n\nMean Y-BOCS score measured at week 8'}, {'id': 'OG002', 'title': 'Treatment With Pill Placebo', 'description': 'Participants received treatment with the placebo\n\nPlacebo : Placebo capsules will be identical in appearance to those of risperidone.\n\nMean Y-BOCS score measured at week 8'}], 'classes': [{'title': 'SAS-SR at Week 0', 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'SAS-SR at Week 8', 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '0.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 and Week 8', 'description': 'SAS-SR yields a mean score between 1 and 5; the higher the score, the more severe the social adjustment problems', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Risperidone', 'description': 'Participants received treatment with risperidone Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated Mean Y-BOCS score measured at week 8'}, {'id': 'OG001', 'title': 'Treatment With Exposure/Response Prevention', 'description': 'Participants received exposure and response prevention therapy\n\nExposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.\n\nMean Y-BOCS score measured at week 8'}, {'id': 'OG002', 'title': 'Treatment With Pill Placebo', 'description': 'Participants received treatment with the placebo\n\nPlacebo : Placebo capsules will be identical in appearance to those of risperidone.\n\nMean Y-BOCS score measured at week 8'}], 'classes': [{'title': 'QLESQ-SF Week 0', 'categories': [{'measurements': [{'value': '52.3', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '57.8', 'spread': '16.2', 'groupId': 'OG001'}, {'value': '56.1', 'spread': '16.2', 'groupId': 'OG002'}]}]}, {'title': 'QLESQ-SF Week 8', 'categories': [{'measurements': [{'value': '55.1', 'spread': '13.9', 'groupId': 'OG000'}, {'value': '70.2', 'spread': '14.2', 'groupId': 'OG001'}, {'value': '62.6', 'spread': '16.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 and Week 8', 'description': 'QLESQ ranges from 14-70, with higher scores meaning more enjoyment and satisfaction with quality of life', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hamilton Depression Rating Scale (Ham-D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Risperidone', 'description': 'Participants will receive treatment with risperidone\n\nRisperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated'}, {'id': 'OG001', 'title': 'Treatment With Exposure/Response Prevention', 'description': 'Participants will receive exposure and response prevention therapy\n\nExposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.'}, {'id': 'OG002', 'title': 'Treatment With Pill Placebo', 'description': 'Participants will receive treatment with the placebo\n\nPlacebo : Placebo capsules will be identical in appearance to those of risperidone.'}], 'classes': [{'title': 'Ham-D at Week 0', 'categories': [{'measurements': [{'value': '9.8', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '6.1', 'groupId': 'OG001'}, {'value': '7.7', 'spread': '5.9', 'groupId': 'OG002'}]}]}, {'title': 'Ham-D at Week 8', 'categories': [{'measurements': [{'value': '8.0', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '6.1', 'groupId': 'OG001'}, {'value': '7.7', 'spread': '5.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 and Week 8', 'description': 'Ham-D ranges from 0=no symptoms to 52 with higher numbers indicating more severe depression', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Brown Assessment of Beliefs (BABS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Risperidone', 'description': 'Participants will receive treatment with risperidone\n\nRisperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated'}, {'id': 'OG001', 'title': 'Treatment With Exposure/Response Prevention', 'description': 'Participants will receive exposure and response prevention therapy\n\nExposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.'}, {'id': 'OG002', 'title': 'Treatment With Pill Placebo', 'description': 'Participants will receive treatment with the placebo\n\nPlacebo : Placebo capsules will be identical in appearance to those of risperidone.'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '5.7', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '4.6', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '3.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '4.5', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '2.9', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '3.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 and Week 8', 'description': 'Scale ranges from 0 to 24 where 0 is "beliefs are false" and 24 is "convinced beliefs = reality"', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment With Risperidone', 'description': 'Participants will receive treatment with risperidone\n\nRisperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated'}, {'id': 'FG001', 'title': 'Treatment With Exposure/Response Prevention', 'description': 'Participants will receive exposure and response prevention therapy\n\nExposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.'}, {'id': 'FG002', 'title': 'Treatment With Pill Placebo', 'description': 'Participants will receive treatment with the placebo\n\nPlacebo : Placebo capsules will be identical in appearance to those of risperidone.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'A randomized clinical trial (conducted January 2007-August 2012) at 2 academic outpatient research clinics that specialize in OCD and anxiety disorders. Patients (aged 18-70 years) were eligible if they had OCD of at least moderate severity despite a therapeutic SRI dose for at least 12 weeks prior to entry.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment With Risperidone', 'description': 'Participants will receive treatment with risperidone\n\nRisperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated'}, {'id': 'BG001', 'title': 'Treatment With Exposure/Response Prevention', 'description': 'Participants will receive exposure and response prevention therapy\n\nExposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.'}, {'id': 'BG002', 'title': 'Treatment With Pill Placebo', 'description': 'Participants will receive treatment with the placebo\n\nPlacebo : Placebo capsules will be identical in appearance to those of risperidone.'}, {'id': 'BG003', '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.8', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '34.3', 'spread': '12.7', 'groupId': 'BG001'}, {'value': '33.4', 'spread': '10.4', 'groupId': 'BG002'}, {'value': '33.9', 'spread': '11.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-20', 'studyFirstSubmitDate': '2006-10-16', 'resultsFirstSubmitDate': '2013-10-29', 'studyFirstSubmitQcDate': '2006-10-17', 'lastUpdatePostDateStruct': {'date': '2014-04-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-20', 'studyFirstPostDateStruct': {'date': '2006-10-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)', 'timeFrame': 'Week 0 and Week 8', 'description': 'Y-BOCS ranges from 0-40, with 0 meaning no symptoms and higher numbers meaning greater symptom severity'}], 'secondaryOutcomes': [{'measure': 'Social Adjustment Scale-SR', 'timeFrame': 'Week 0 and Week 8', 'description': 'SAS-SR yields a mean score between 1 and 5; the higher the score, the more severe the social adjustment problems'}, {'measure': 'Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form', 'timeFrame': 'Week 0 and Week 8', 'description': 'QLESQ ranges from 14-70, with higher scores meaning more enjoyment and satisfaction with quality of life'}, {'measure': 'Hamilton Depression Rating Scale (Ham-D)', 'timeFrame': 'Week 0 and Week 8', 'description': 'Ham-D ranges from 0=no symptoms to 52 with higher numbers indicating more severe depression'}, {'measure': 'Brown Assessment of Beliefs (BABS)', 'timeFrame': 'Week 0 and Week 8', 'description': 'Scale ranges from 0 to 24 where 0 is "beliefs are false" and 24 is "convinced beliefs = reality"'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['OCD', 'Augmentation', 'Antipsychotics', 'Cognitive-Behavioral Therapy'], 'conditions': ['Obsessive-Compulsive Disorder']}, 'referencesModule': {'references': [{'pmid': '24026523', 'type': 'RESULT', 'citation': 'Simpson HB, Foa EB, Liebowitz MR, Huppert JD, Cahill S, Maher MJ, McLean CP, Bender J Jr, Marcus SM, Williams MT, Weaver J, Vermes D, Van Meter PE, Rodriguez CI, Powers M, Pinto A, Imms P, Hahn CG, Campeas R. Cognitive-behavioral therapy vs risperidone for augmenting serotonin reuptake inhibitors in obsessive-compulsive disorder: a randomized clinical trial. JAMA Psychiatry. 2013 Nov;70(11):1190-9. doi: 10.1001/jamapsychiatry.2013.1932.'}, {'pmid': '26613263', 'type': 'DERIVED', 'citation': 'McLean CP, Zandberg LJ, Van Meter PE, Carpenter JK, Simpson HB, Foa EB. Exposure and response prevention helps adults with obsessive-compulsive disorder who do not respond to pharmacological augmentation strategies. J Clin Psychiatry. 2015 Dec;76(12):1653-7. doi: 10.4088/JCP.14m09513.'}, {'pmid': '25375780', 'type': 'DERIVED', 'citation': 'Foa EB, Simpson HB, Rosenfield D, Liebowitz MR, Cahill SP, Huppert JD, Bender J Jr, McLean CP, Maher MJ, Campeas R, Hahn CG, Imms P, Pinto A, Powers MB, Rodriguez CI, Van Meter PE, Vermes D, Williams MT. Six-month outcomes from a randomized trial augmenting serotonin reuptake inhibitors with exposure and response prevention or risperidone in adults with obsessive-compulsive disorder. J Clin Psychiatry. 2015 Apr;76(4):440-6. doi: 10.4088/JCP.14m09044.'}, {'pmid': '23945445', 'type': 'DERIVED', 'citation': 'Farris SG, McLean CP, Van Meter PE, Simpson HB, Foa EB. Treatment response, symptom remission, and wellness in obsessive-compulsive disorder. J Clin Psychiatry. 2013 Jul;74(7):685-90. doi: 10.4088/JCP.12m07789.'}], 'seeAlsoLinks': [{'url': 'http://www.columbia-ocd.org/', 'label': 'Click here for the Columbia University Obsessive-Compulsive Disorder Research Clinic website'}, {'url': 'http://www.med.upenn.edu/ctsa/', 'label': 'Click here for the University of Pennsylvania Center for the Treatment and Study of Anxiety website'}, {'url': 'http://www.clinicaltrials.gov/show/NCT00045903', 'label': "Click here to view the ClinicalTrials.gov record of this trial's parent study"}]}, 'descriptionModule': {'briefSummary': 'This study will compare the short- and long-term effectiveness of two common therapies in improving serotonin reuptake inhibitor treatment in people with obsessive-compulsive disorder.', 'detailedDescription': "Obsessive-compulsive disorder (OCD) is a common psychiatric illness. People with OCD experience unwelcome thoughts, known as obsessions, and feel compelled to perform repetitive behaviors, or compulsions. Impairment due to OCD symptoms ranges from mild to severe, and sometimes can be disabling. The only medications proven effective for OCD are serotonin reuptake inhibitors (SRIs), but even with SRI treatment, most patients continue to experience significant OCD symptoms, impaired functioning, and diminished quality of life. Cognitive-behavioral therapy (CBT), a talking therapy that focuses on altering a person's thoughts and behaviors, and the medication risperidone have both been commonly used for augmenting SRI treatment for OCD. This study will compare the short- and long-term effectiveness of exposure and ritual prevention (EX/RP), a type of CBT, and risperidone in augmenting SRI treatment in people with OCD.\n\nParticipants in this double-blind study will be randomly assigned to receive EX/RP, risperidone, or placebo in conjunction with their regular SRI medication. All participants will remain on their regular SRI at a stable dose. During the first 2 months of the study, participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response. Participants assigned to risperidone or placebo will meet with a psychiatrist once every 1 to 2 weeks. At the end of 8 weeks, all participants' OCD symptom severity will be assessed. During this time, participants who have responded to treatment will continue receiving the same treatment for an additional 24 weeks. Participants assigned to EX/RP will meet with a therapist no more than 15 times total, and participants receiving risperidone or placebo will meet with a psychiatrist once every 4 weeks. Outcomes will be reassessed at study completion.\n\nOrtho McNeil Janssen Scientific Affairs, LLC are providing medication and placebos for this study.\n\nFor information on a related study, please follow this link:\n\nhttp://clinicaltrials.gov/show/NCT00045903"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary diagnosis of OCD\n* Currently on a stable and adequate dose of an SRI\n* Sufficient severity of symptoms to warrant additional augmentation treatment\n\nExclusion Criteria:\n\n* Medical or psychiatric conditions that would make participation in the study unsafe\n* Currently receiving psychotherapy elsewhere at the time of study entry\n* Previously (within 12 weeks prior to study entry) attended 8 or more sessions of EX/RP within a 2-month period or received at least 4 weeks of antipsychotic augmentation while on an adequate SRI dose\n* Currently being treated with an SRI for the first time and has not yet responded, but has not tried another SRI'}, 'identificationModule': {'nctId': 'NCT00389493', 'briefTitle': 'Risperidone or Cognitive-Behavioral Therapy for Improving Medication Treatment for Obsessive-compulsive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'New York State Psychiatric Institute'}, 'officialTitle': 'Maximizing Treatment Outcome in OCD', 'orgStudyIdInfo': {'id': '#5188/#6258R'}, 'secondaryIdInfos': [{'id': 'R01MH045436-02', 'link': 'https://reporter.nih.gov/quickSearch/R01MH045436-02', 'type': 'NIH'}, {'id': 'DSIR 83-ATAS'}, {'id': 'R01MH045436', 'link': 'https://reporter.nih.gov/quickSearch/R01MH045436', 'type': 'NIH'}, {'id': 'R01MH045404', 'link': 'https://reporter.nih.gov/quickSearch/R01MH045404', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Participants will receive treatment with risperidone', 'interventionNames': ['Drug: Risperidone']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Participants will receive exposure and ritual prevention therapy (EX/RP)', 'interventionNames': ['Behavioral: Exposure/ritual prevention therapy (EX/RP)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'Participants will receive treatment with the placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Risperidone', 'type': 'DRUG', 'otherNames': ['Risperdal'], 'description': 'Dosage of 0.5 mg to 4.0 mg per day as tolerated', 'armGroupLabels': ['1']}, {'name': 'Exposure/ritual prevention therapy (EX/RP)', 'type': 'BEHAVIORAL', 'otherNames': ['EX/RP'], 'description': 'EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['PBO'], 'description': 'Placebo capsules will be identical in appearance to those of risperidone.', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York State Psychiatric Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Center for the Treatment and Study of Anxiety', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Blair Simpson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York State Psychiatric Institute'}, {'name': 'Edna Foa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York State Psychiatric Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}