Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-02-25 @ 5:52 PM
Study NCT ID:
NCT00095134
Status:
COMPLETED
Last Update Posted:
2011-12-06
First Post:
2004-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 630}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-05', 'studyFirstSubmitDate': '2004-11-01', 'studyFirstSubmitQcDate': '2004-10-29', 'lastUpdatePostDateStruct': {'date': '2011-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in therapeutic effect of risperidone and placebo as measured by change in depression rating scale (HAM-D) at end of week 4 of the double-blind phase.'}], 'secondaryOutcomes': [{'measure': 'Safety will be assessed through reported adverse events and vital signs (weight, blood pressure, pulse, and temperature).'}]}, 'conditionsModule': {'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '23849714', 'type': 'DERIVED', 'citation': 'Pandina G, Turkoz I, Bossie C. Impact of self-reported juvenile abuse on treatment outcome in patients with major depressive disorder. J Affect Disord. 2013 Oct;151(1):384-91. doi: 10.1016/j.jad.2013.01.053. Epub 2013 Jul 10.'}, {'pmid': '17975181', 'type': 'DERIVED', 'citation': 'Mahmoud RA, Pandina GJ, Turkoz I, Kosik-Gonzalez C, Canuso CM, Kujawa MJ, Gharabawi-Garibaldi GM. Risperidone for treatment-refractory major depressive disorder: a randomized trial. Ann Intern Med. 2007 Nov 6;147(9):593-602. doi: 10.7326/0003-4819-147-9-200711060-00003.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to evaluate the efficacy and safety of risperidone versus placebo in subjects with Major Depressive Disorder with sub-optimal response to antidepressant therapy.', 'detailedDescription': 'Many patients who suffer from Major Depressive Disorder (MDD) do not benefit or show only partial benefit from current psychotropic therapy. This clinical trial seeks to study the efficacy and safety of adjunctive treatment with risperidone in patients with MDD who failed to adequately respond to standard antidepressant treatment prior to this trial and who prospectively do not respond to adequate treatment with standard antidepressant therapy (SAD).\n\nPatients entering the open label phase of the study will have already taken a commercially available SAD for a minimum of 4 weeks, and provided the dose was optimal, will continue on this dose of SAD throughout the four-week open-label and six-week double-blind phases of the trial.\n\nIf the dose in the four weeks prior to entering the study was not optimal (as per standard clinical practice), the dose will be increased to be within the optimal range and continued at that dose through the entire open-label SAD and double-blind phases.\n\nDuring the double-blind phase, subjects receive an adjunctive dose of risperidone or placebo, once daily, added to their stable dose of SAD. The starting dose of risperidone or placebo is 0.25 mg for the first three days of the double-blind phase, and is increased to 0.5 mg for days 4 through 14. On the 15th day of this phase, the dose is increased to the target dose of 1.0 mg/day. If response to this dose is not optimal by day 29, it is increased to 2.0 mg/day and is maintained for the duration of the 6-week double-blind phase. This dose may be reduced once to 1.0 mg/day, but then must be maintained at that dose for the remainder of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Understand and sign the informed consent form\n* Age 18-65\n* Healthy on the basis of Physical Exam\n* Treatment with a single antidepressant 4 weeks prior to study start and willingness to maintain on stable dose of the same antidepressant throughout the study\n* Current diagnosis of Major Depressive Disorder\n* Judgement of the clinician that the subject has shown a sub-optimal response to the antidepressant\n\nExclusion Criteria:\n\n* Presence of other serious medical illness(es)'}, 'identificationModule': {'nctId': 'NCT00095134', 'briefTitle': 'Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.'}, 'officialTitle': 'A Double-Blind Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy', 'orgStudyIdInfo': {'id': 'CR004726'}}, 'armsInterventionsModule': {'interventions': [{'name': 'risperidone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Innovative Clinical Trials, LLC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35242', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Greystone Medical Research', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Scottsdale Family Health', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85351', 'city': 'Sun City', 'state': 'Arizona', 'country': 'United States', 'facility': 'Sun Valley Medical', 'geoPoint': {'lat': 33.59754, 'lon': -112.27182}}, {'zip': '85711', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Southwest Biomedical Research Foundation', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91506', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Southwestern Research Institute', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '90301', 'city': 'Inglewood', 'state': 'California', 'country': 'United States', 'facility': 'Chrishard Clinical Research', 'geoPoint': {'lat': 33.96168, 'lon': -118.35313}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Optimum Health Services', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Insititute for Medical Research', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Optimum Health Services', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '92506', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Behavioral Health 2000, LLC', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'nTouch Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '06320', 'city': 'New London', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Psychiatric Medicine Center', 'geoPoint': {'lat': 41.35565, 'lon': -72.09952}}, {'zip': '19702', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Glasgow Family Practice', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '33311', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Leonard Bass, MD, PA', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32607', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Sarkis Clinical Trials', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32257', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Roger Miller, MD', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33161', 'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'BioQuan Research Group, Inc.', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '34769', 'city': 'Saint Cloud', 'state': 'Florida', 'country': 'United States', 'facility': 'Family Practice - St. Cloud', 'geoPoint': {'lat': 28.2489, 'lon': -81.28118}}, {'zip': '60005', 'city': 'Arlington Heights', 'state': 'Illinois', 'country': 'United States', 'facility': 'Allan B. 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