Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy
This study has been completed.
Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborator:
Janssen, LP
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00095134
First received: November 1, 2004
Last updated: December 5, 2011
Last verified: December 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder |
Drug: risperidone |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Double-Blind Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy |
Resource links provided by NLM:
MedlinePlus related topics:
Depression
Drug Information available for:
Risperidone
U.S. FDA Resources
Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- Safety will be assessed through reported adverse events and vital signs (weight, blood pressure, pulse, and temperature).
| Enrollment: | 630 |
| Study Start Date: | October 2004 |
| Study Completion Date: | November 2005 |
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).
Patients 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.
If 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.
During 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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Understand and sign the informed consent form
- Age 18-65
- Healthy on the basis of Physical Exam
- 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
- Current diagnosis of Major Depressive Disorder
- Judgement of the clinician that the subject has shown a sub-optimal response to the antidepressant
Exclusion Criteria:
- Presence of other serious medical illness(es)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00095134
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| United States, Alabama | |
| Innovative Clinical Trials, LLC | |
| Birmingham, Alabama, United States, 35205 | |
| Greystone Medical Research | |
| Birmingham, Alabama, United States, 35242 | |
| United States, Arizona | |
| Scottsdale Family Health | |
| Scottsdale, Arizona, United States, 85251 | |
| Sun Valley Medical | |
| Sun City, Arizona, United States, 85351 | |
| Southwest Biomedical Research Foundation | |
| Tucson, Arizona, United States, 85711 | |
| United States, California | |
| Southwestern Research Institute | |
| Burbank, California, United States, 91506 | |
| Chrishard Clinical Research | |
| Inglewood, California, United States, 90301 | |
| Optimum Health Services | |
| La Mesa, California, United States, 91942 | |
| Pacific Insititute for Medical Research | |
| Los Angeles, California, United States, 90024 | |
| Optimum Health Services | |
| Oceanside, California, United States, 92056 | |
| Behavioral Health 2000, LLC | |
| Riverside, California, United States, 92506 | |
| nTouch Research | |
| San Diego, California, United States, 92103 | |
| United States, Connecticut | |
| Psychiatric Medicine Center | |
| New London, Connecticut, United States, 06320 | |
| United States, Delaware | |
| Glasgow Family Practice | |
| Newark, Delaware, United States, 19702 | |
| United States, Florida | |
| Leonard Bass, MD, PA | |
| Ft. Lauderdale, Florida, United States, 33311 | |
| Sarkis Clinical Trials | |
| Gainesville, Florida, United States, 32607 | |
| Roger Miller, MD | |
| Jacksonville, Florida, United States, 32257 | |
| BioQuan Research Group, Inc. | |
| North Miami, Florida, United States, 33161 | |
| Family Practice - St. Cloud | |
| St. Cloud, Florida, United States, 34769 | |
| United States, Illinois | |
| Allan B. Aven, MD | |
| Arlington Heights, Illinois, United States, 60005 | |
| nTouch Research - Chicago | |
| Naperville, Illinois, United States, 60542 | |
| Balanced Health Research Center | |
| Peoria, Illinois, United States, 61614 | |
| nTouch Research - Peoria | |
| Peoria, Illinois, United States, 61602 | |
| United States, Indiana | |
| American Health Network | |
| Avon, Indiana, United States, 46123 | |
| Research Solutions - Evansville | |
| Evansville, Indiana, United States, 47714 | |
| Amy Kaissar, MD | |
| Indianapolis, Indiana, United States, 46260 | |
| Clinco | |
| Terre Haute, Indiana, United States, 47802 | |
| United States, Kentucky | |
| Hartford Research Group | |
| Florence, Kentucky, United States, 41042 | |
| United States, Louisiana | |
| New Orleans Medical Institute | |
| Metairie, Louisiana, United States, 70001 | |
| Brentwood Research Institute | |
| Shreveport, Louisiana, United States, 71101 | |
| United States, Michigan | |
| Professional Clinical Research at Great Lakes Family Care | |
| Cadillac, Michigan, United States, 49601 | |
| United States, Missouri | |
| Sam Hawatmeh, MD, PC | |
| St. Louis, Missouri, United States, 63125 | |
| United States, Nebraska | |
| Alliance Medical Center, PC | |
| Alliance, Nebraska, United States, 69301 | |
| United States, New Jersey | |
| Clinical Trial Associates | |
| Glendora, New Jersey, United States, 08029 | |
| Partners in Primary Care | |
| Turnersville, New Jersey, United States, 08012 | |
| United States, New Mexico | |
| ABQ Med., P.C. | |
| Albuquerque, New Mexico, United States, 81709 | |
| United States, New York | |
| Eastside Comprehensive Medical Services, LLC | |
| New York, New York, United States, 10021 | |
| United States, North Carolina | |
| Raleigh Medical Group | |
| Raleigh, North Carolina, United States, 27609 | |
| Salem Research Group | |
| Winston Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Community Health Care, Inc. | |
| Canal Fulton, Ohio, United States, 44614 | |
| Hightop Medical Research Center | |
| Cincinnati, Ohio, United States, 45224 | |
| Community Research Management Associates, Inc. | |
| Cincinnati, Ohio, United States, 45219 | |
| CFP Research, Inc. | |
| Cincinnati, Ohio, United States, 45242 | |
| Martin Schear, MD | |
| Dayton, Ohio, United States, 45406 | |
| Family Practice Center of Wadsworth | |
| Wadsworth, Ohio, United States, 44281 | |
| United States, Oklahoma | |
| Sooner Clinical Research | |
| Edmond, Oklahoma, United States, 73013 | |
| Med-line Research | |
| Moore, Oklahoma, United States, 73160 | |
| Cutting Edge Research Group | |
| Oklahoma City, Oklahoma, United States, 73120 | |
| United States, Oregon | |
| Advanced Clinical Trials | |
| Eugene, Oregon, United States, 97401 | |
| Medford Medical Clinic, LLP | |
| Medford, Oregon, United States, 97504 | |
| Clinical Research Consultants/Providence Medical | |
| Medford, Oregon, United States, 97504 | |
| United States, Pennsylvania | |
| Gateway Medical | |
| Downingtown, Pennsylvania, United States, 19335 | |
| Feasterville Family Health Care | |
| Feasterville, Pennsylvania, United States, 19053 | |
| Detweiler Family Medicine | |
| Lansdale, Pennsylvania, United States, 19446 | |
| Green & Seidner Family Practice | |
| Lansdale, Pennsylvania, United States, 19466 | |
| Woodburne Family Practice | |
| Levittown, Pennsylvania, United States, 19057 | |
| Pearl Clinical Research | |
| Norristown, Pennsylvania, United States, 19401 | |
| Joseph Rybicki, MD | |
| Philadelphia, Pennsylvania, United States, 19152 | |
| Clinical Trials Research Services, LLC | |
| Pittsburgh, Pennsylvania, United States, 15206 | |
| Consolidated Clinical Trials, Inc. | |
| Pittsburgh, Pennsylvania, United States, 15221 | |
| Charles Buttz, MD | |
| Pottstown, Pennsylvania, United States, 19465 | |
| Research Across America | |
| Reading, Pennsylvania, United States, 19606 | |
| United States, South Carolina | |
| The Family Practice | |
| Greer, South Carolina, United States, 29651 | |
| United States, Tennessee | |
| Harmony Clinical Research | |
| Johnson City, Tennessee, United States, 37601 | |
| United States, Texas | |
| DiscoveResearch, Inc. | |
| Beaumont, Texas, United States, 77701 | |
| South Texas Applied Research | |
| Corpus Christi, Texas, United States, 78411 | |
| United States, Virginia | |
| International Clinical Research Associates, LLC | |
| Richmond, Virginia, United States, 23294 | |
| International Clinical Research Associates | |
| Virgina Beach, Virginia, United States, 23452 | |
| United States, Washington | |
| Richard Neiman, MD | |
| Kirkland, Washington, United States, 98034 | |
| Daniel Blizzard, MD | |
| Spokane, Washington, United States, 99216 | |
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Janssen, LP
More Information
No publications provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00095134 History of Changes |
| Other Study ID Numbers: | CR004726 |
| Study First Received: | November 1, 2004 |
| Last Updated: | December 5, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Risperidone Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on May 22, 2013