Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-26 @ 3:47 PM
Study NCT ID:
NCT00758966
Status:
TERMINATED
Last Update Posted:
2012-11-29
First Post:
2008-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Naltrexone SR and Fluoxetine Combination Therapy in Subjects With Obsessive-Compulsive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D005473', 'term': 'Fluoxetine'}, {'id': 'D009271', 'term': 'Naltrexone'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009270', 'term': 'Naloxone'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'Sponsor Decision- Financial Considerations', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'dispFirstSubmitDate': '2012-11-27', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-27', 'studyFirstSubmitDate': '2008-09-22', 'dispFirstSubmitQcDate': '2012-11-27', 'studyFirstSubmitQcDate': '2008-09-23', 'dispFirstPostDateStruct': {'date': '2012-11-29', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the mean change from baseline to Week 10 in total Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score between the combination treatment group versus fluoxetine alone and naltrexone SR alone', 'timeFrame': 'Baseline to Week 10'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['OCD,', 'naltrexone,', 'fluoxetine,', 'obsessive-compulsive disorder'], 'conditions': ['Obsessive-Compulsive Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the combination of naltrexone SR and fluoxetine is more effective in treating the symptoms of obsessive-compulsive disorder (OCD)than either fluoxetine alone or naltrexone SR alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female subjects, 18 to 60 years of age (inclusive)\n* Outpatients with a current diagnosis of OCD that have received previous therapy\n* Negative serum pregnancy test as screening in women of child-bearing potential\n* If a woman of child-bearing potential, must agreed to use an acceptable and effective form of contraception\n* No clinically significant abnormality on electrocardiogram (ECG)\n* No clinically significant laboratory abnormality at screening\n* Negative urine drug screen\n* Must be considered reliable and possess a level of understanding that enables the subject to provide written informed consent and to comply with protocol procedures and schedule\n\nExclusion Criteria:\n\n* Diagnosis of substance dependence\n* Diagnosis of substance abuse (except for nicotine and caffeine)\n* Serious or unstable medical illnesses\n* Lifetime history of bipolar disorder, schizophrenia or other psychosis, bulimia, anorexia nervosa, Pervasive Developmental Disorder (PDD), Asperger's Syndrome or the presence of antisocial or borderline personality disorder\n* Diagnosis of tic disorder or Tourette's Syndrome\n* Subjects diagnosed with impulse control disorder\n* Known sensitivity or allergic reaction to either naltrexone or fluoxetine\n* Any condition which in the opinion of the investigator or Sponsor makes the subject unsuitable for inclusion in the study\n* Immediate family of investigators, study personnel or Sponsor representatives"}, 'identificationModule': {'nctId': 'NCT00758966', 'briefTitle': 'Naltrexone SR and Fluoxetine Combination Therapy in Subjects With Obsessive-Compulsive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Orexigen Therapeutics, Inc'}, 'officialTitle': 'A Proof-of-Concept, Multicenter, Randomized, Double-Blind, Parallel Study of Naltrexone Sustained-Release (SR) and/or Fluoxetine Therapy in the Treatment of Subjects With Obsessive-Compulsive Disorder (OCD)', 'orgStudyIdInfo': {'id': 'NF-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NF (Naltrexone+Fluoxetine)', 'description': 'Naltrexone SR 32 mg and fluoxetine 60 mg', 'interventionNames': ['Drug: Naltrexone 32 mg and fluoxetine 60 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluoxetine', 'description': 'Fluoxetine 60 mg', 'interventionNames': ['Drug: Fluoxetine 60 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Naltrexone', 'description': 'Naltrexone SR 32 mg', 'interventionNames': ['Drug: Naltrexone SR 32 mg']}], 'interventions': [{'name': 'Fluoxetine 60 mg', 'type': 'DRUG', 'description': 'Two week titration followed by daily dosing of fluoxetine 60 mg for 8 weeks. Response is assessed at after 8 weeks. Responders will continue on fluoxetine 60 mg for an additional 6 weeks. Non-responders will have naltrexone SR 32 mg added to their therapy.', 'armGroupLabels': ['Fluoxetine']}, {'name': 'Naltrexone 32 mg and fluoxetine 60 mg', 'type': 'DRUG', 'description': 'Two week titration followed by daily dosing of naltrexone SR 32 mg and fluoxetine 60 mg for 8 weeks. Response is assessed at after 8 weeks. Responders will continue on a daily dose of naltrexone SR 32 mg and fluoxetine 60 mg for an additional 6 weeks. Non-responders will have their daily dose adjusted to naltrexone SR 48 mg and fluoxetine 80 mg.', 'armGroupLabels': ['NF (Naltrexone+Fluoxetine)']}, {'name': 'Naltrexone SR 32 mg', 'type': 'DRUG', 'description': 'Two week titration followed by daily dosing of naltrexone SR 32 mg for 8 weeks. Response is assessed at after 8 weeks. Responders will continue on naltrexone SR 32 mg for an additional 6 weeks. Non-responders will have fluoxetine 60 mg added to their therapy.', 'armGroupLabels': ['Naltrexone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91950', 'city': 'National City', 'state': 'California', 'country': 'United States', 'facility': 'Synergy Clinical Research', 'geoPoint': {'lat': 32.67811, 'lon': -117.0992}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'California Clinical Trials', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32606', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida, Department of Psychiatry', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Center for Medical Research', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University School of Medicine', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '08540', 'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Global Medical Institute, LLC', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}, {'zip': '11223', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Brooklyn Medical Institute', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '45227', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Community Research', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Summit Research Network, Inc.', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '29201', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolina Clinical Research Services', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '53223', 'city': 'Brown Deer', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Northbrooke Research Center', 'geoPoint': {'lat': 43.16334, 'lon': -87.96453}}], 'overallOfficials': [{'name': 'Jeffrey T Apter, MD, PA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Global Medical Institutes, LLC'}, {'name': 'Ward Smith, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Summit Research Network, Inc.'}, {'name': 'Vishaal Mehra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'California Clinical Trials'}, {'name': 'Naresh P Emmanuel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carolina Clinical Research Services'}, {'name': 'Mohammad Bari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Synergy Clinical Research'}, {'name': 'Robert Riesenberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Atlanta Center for Medical Research'}, {'name': 'Teresa Pigott, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida, Dept Of Psychiatry'}, {'name': 'Andrew W Goddard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University School of Medicine'}, {'name': 'Al Rivera, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Community Research'}, {'name': 'Jeffrey S Simon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northbrooke Research Center'}, {'name': 'Zinoviy Benzar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brooklyn Medical Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orexigen Therapeutics, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}