Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy
- Conditions
- Major Depressive Disorder
- Registration Number
- NCT00095134
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 630
- 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
- Presence of other serious medical illness(es)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method Safety will be assessed through reported adverse events and vital signs (weight, blood pressure, pulse, and temperature).
Trial Locations
- Locations (69)
Southwestern Research Institute
🇺🇸Burbank, California, United States
Southwest Biomedical Research Foundation
🇺🇸Tucson, Arizona, United States
nTouch Research - Peoria
🇺🇸Peoria, Illinois, United States
American Health Network
🇺🇸Avon, Indiana, United States
Glasgow Family Practice
🇺🇸Newark, Delaware, United States
BioQuan Research Group, Inc.
🇺🇸North Miami, Florida, United States
Scottsdale Family Health
🇺🇸Scottsdale, Arizona, United States
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
Family Practice - St. Cloud
🇺🇸St. Cloud, Florida, United States
Behavioral Health 2000, LLC
🇺🇸Riverside, California, United States
Clinical Research Consultants/Providence Medical
🇺🇸Medford, Oregon, United States
Greystone Medical Research
🇺🇸Birmingham, Alabama, United States
Clinical Trials Research Services, LLC
🇺🇸Pittsburgh, Pennsylvania, United States
Eastside Comprehensive Medical Services, LLC
🇺🇸New York, New York, United States
Sun Valley Medical
🇺🇸Sun City, Arizona, United States
Roger Miller, MD
🇺🇸Jacksonville, Florida, United States
New Orleans Medical Institute
🇺🇸Metairie, Louisiana, United States
Allan B. Aven, MD
🇺🇸Arlington Heights, Illinois, United States
Innovative Clinical Trials, LLC
🇺🇸Birmingham, Alabama, United States
Leonard Bass, MD, PA
🇺🇸Ft. Lauderdale, Florida, United States
Psychiatric Medicine Center
🇺🇸New London, Connecticut, United States
nTouch Research - Chicago
🇺🇸Naperville, Illinois, United States
Pacific Insititute for Medical Research
🇺🇸Los Angeles, California, United States
Chrishard Clinical Research
🇺🇸Inglewood, California, United States
DiscoveResearch, Inc.
🇺🇸Beaumont, Texas, United States
Community Health Care, Inc.
🇺🇸Canal Fulton, Ohio, United States
Martin Schear, MD
🇺🇸Dayton, Ohio, United States
Gateway Medical
🇺🇸Downingtown, Pennsylvania, United States
Detweiler Family Medicine
🇺🇸Lansdale, Pennsylvania, United States
Research Across America
🇺🇸Reading, Pennsylvania, United States
Brentwood Research Institute
🇺🇸Shreveport, Louisiana, United States
Sam Hawatmeh, MD, PC
🇺🇸St. Louis, Missouri, United States
Medford Medical Clinic, LLP
🇺🇸Medford, Oregon, United States
Joseph Rybicki, MD
🇺🇸Philadelphia, Pennsylvania, United States
Research Solutions - Evansville
🇺🇸Evansville, Indiana, United States
Alliance Medical Center, PC
🇺🇸Alliance, Nebraska, United States
Charles Buttz, MD
🇺🇸Pottstown, Pennsylvania, United States
Clinical Trial Associates
🇺🇸Glendora, New Jersey, United States
Med-line Research
🇺🇸Moore, Oklahoma, United States
Woodburne Family Practice
🇺🇸Levittown, Pennsylvania, United States
Richard Neiman, MD
🇺🇸Kirkland, Washington, United States
Daniel Blizzard, MD
🇺🇸Spokane, Washington, United States
Raleigh Medical Group
🇺🇸Raleigh, North Carolina, United States
South Texas Applied Research
🇺🇸Corpus Christi, Texas, United States
Consolidated Clinical Trials, Inc.
🇺🇸Pittsburgh, Pennsylvania, United States
Family Practice Center of Wadsworth
🇺🇸Wadsworth, Ohio, United States
Cutting Edge Research Group
🇺🇸Oklahoma City, Oklahoma, United States
Pearl Clinical Research
🇺🇸Norristown, Pennsylvania, United States
Hightop Medical Research Center
🇺🇸Cincinnati, Ohio, United States
nTouch Research
🇺🇸San Diego, California, United States
Amy Kaissar, MD
🇺🇸Indianapolis, Indiana, United States
CFP Research, Inc.
🇺🇸Cincinnati, Ohio, United States
Community Research Management Associates, Inc.
🇺🇸Cincinnati, Ohio, United States
Salem Research Group
🇺🇸Winston Salem, North Carolina, United States
Optimum Health Services
🇺🇸Oceanside, California, United States
Professional Clinical Research at Great Lakes Family Care
🇺🇸Cadillac, Michigan, United States
Partners in Primary Care
🇺🇸Turnersville, New Jersey, United States
Sooner Clinical Research
🇺🇸Edmond, Oklahoma, United States
ABQ Med., P.C.
🇺🇸Albuquerque, New Mexico, United States
Hartford Research Group
🇺🇸Florence, Kentucky, United States
Clinco
🇺🇸Terre Haute, Indiana, United States
Harmony Clinical Research
🇺🇸Johnson City, Tennessee, United States
Green & Seidner Family Practice
🇺🇸Lansdale, Pennsylvania, United States
Advanced Clinical Trials
🇺🇸Eugene, Oregon, United States
International Clinical Research Associates
🇺🇸Virgina Beach, Virginia, United States
Feasterville Family Health Care
🇺🇸Feasterville, Pennsylvania, United States
Balanced Health Research Center
🇺🇸Peoria, Illinois, United States
The Family Practice
🇺🇸Greer, South Carolina, United States
International Clinical Research Associates, LLC
🇺🇸Richmond, Virginia, United States