Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy
NCT ID: NCT00095134
Last Updated: 2011-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
630 participants
INTERVENTIONAL
2004-10-31
2005-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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risperidone
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Janssen, LP
INDUSTRY
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
Locations
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Innovative Clinical Trials, LLC
Birmingham, Alabama, United States
Greystone Medical Research
Birmingham, Alabama, United States
Scottsdale Family Health
Scottsdale, Arizona, United States
Sun Valley Medical
Sun City, Arizona, United States
Southwest Biomedical Research Foundation
Tucson, Arizona, United States
Southwestern Research Institute
Burbank, California, United States
Chrishard Clinical Research
Inglewood, California, United States
Optimum Health Services
La Mesa, California, United States
Pacific Insititute for Medical Research
Los Angeles, California, United States
Optimum Health Services
Oceanside, California, United States
Behavioral Health 2000, LLC
Riverside, California, United States
nTouch Research
San Diego, California, United States
Psychiatric Medicine Center
New London, Connecticut, United States
Glasgow Family Practice
Newark, Delaware, United States
Leonard Bass, MD, PA
Fort Lauderdale, Florida, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Roger Miller, MD
Jacksonville, Florida, United States
BioQuan Research Group, Inc.
North Miami, Florida, United States
Family Practice - St. Cloud
Saint Cloud, Florida, United States
Allan B. Aven, MD
Arlington Heights, Illinois, United States
nTouch Research - Chicago
Naperville, Illinois, United States
nTouch Research - Peoria
Peoria, Illinois, United States
Balanced Health Research Center
Peoria, Illinois, United States
American Health Network
Avon, Indiana, United States
Research Solutions - Evansville
Evansville, Indiana, United States
Amy Kaissar, MD
Indianapolis, Indiana, United States
Clinco
Terre Haute, Indiana, United States
Hartford Research Group
Florence, Kentucky, United States
New Orleans Medical Institute
Metairie, Louisiana, United States
Brentwood Research Institute
Shreveport, Louisiana, United States
Professional Clinical Research at Great Lakes Family Care
Cadillac, Michigan, United States
Sam Hawatmeh, MD, PC
St Louis, Missouri, United States
Alliance Medical Center, PC
Alliance, Nebraska, United States
Clinical Trial Associates
Glendora, New Jersey, United States
Partners in Primary Care
Turnersville, New Jersey, United States
ABQ Med., P.C.
Albuquerque, New Mexico, United States
Eastside Comprehensive Medical Services, LLC
New York, New York, United States
Raleigh Medical Group
Raleigh, North Carolina, United States
Salem Research Group
Winston-Salem, North Carolina, United States
Community Health Care, Inc.
Canal Fulton, Ohio, United States
Community Research Management Associates, Inc.
Cincinnati, Ohio, United States
Hightop Medical Research Center
Cincinnati, Ohio, United States
CFP Research, Inc.
Cincinnati, Ohio, United States
Martin Schear, MD
Dayton, Ohio, United States
Family Practice Center of Wadsworth
Wadsworth, Ohio, United States
Sooner Clinical Research
Edmond, Oklahoma, United States
Med-line Research
Moore, Oklahoma, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States
Advanced Clinical Trials
Eugene, Oregon, United States
Clinical Research Consultants/Providence Medical
Medford, Oregon, United States
Medford Medical Clinic, LLP
Medford, Oregon, United States
Gateway Medical
Downingtown, Pennsylvania, United States
Feasterville Family Health Care
Feasterville, Pennsylvania, United States
Detweiler Family Medicine
Lansdale, Pennsylvania, United States
Green & Seidner Family Practice
Lansdale, Pennsylvania, United States
Woodburne Family Practice
Levittown, Pennsylvania, United States
Pearl Clinical Research
Norristown, Pennsylvania, United States
Joseph Rybicki, MD
Philadelphia, Pennsylvania, United States
Clinical Trials Research Services, LLC
Pittsburgh, Pennsylvania, United States
Consolidated Clinical Trials, Inc.
Pittsburgh, Pennsylvania, United States
Charles Buttz, MD
Pottstown, Pennsylvania, United States
Research Across America
Reading, Pennsylvania, United States
The Family Practice
Greer, South Carolina, United States
Harmony Clinical Research
Johnson City, Tennessee, United States
DiscoveResearch, Inc.
Beaumont, Texas, United States
South Texas Applied Research
Corpus Christi, Texas, United States
International Clinical Research Associates, LLC
Richmond, Virginia, United States
International Clinical Research Associates
Virgina Beach, Virginia, United States
Richard Neiman, MD
Kirkland, Washington, United States
Daniel Blizzard, MD
Spokane, Washington, United States
Countries
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References
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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.
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.
Other Identifiers
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CR004726
Identifier Type: -
Identifier Source: org_study_id