Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy
A Double-Blind Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy
1 other identifier
interventional
630
1 country
70
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 major-depressive-disorder
Started Oct 2004
Shorter than P25 for phase_3 major-depressive-disorder
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 1, 2004
CompletedFirst Posted
Study publicly available on registry
November 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedDecember 6, 2011
December 1, 2011
November 1, 2004
December 5, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Safety will be assessed through reported adverse events and vital signs (weight, blood pressure, pulse, and temperature).
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Presence of other serious medical illness(es)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (70)
Innovative Clinical Trials, LLC
Birmingham, Alabama, 35205, United States
Greystone Medical Research
Birmingham, Alabama, 35242, United States
Scottsdale Family Health
Scottsdale, Arizona, 85251, United States
Sun Valley Medical
Sun City, Arizona, 85351, United States
Southwest Biomedical Research Foundation
Tucson, Arizona, 85711, United States
Southwestern Research Institute
Burbank, California, 91506, United States
Chrishard Clinical Research
Inglewood, California, 90301, United States
Optimum Health Services
La Mesa, California, 91942, United States
Pacific Insititute for Medical Research
Los Angeles, California, 90024, United States
Optimum Health Services
Oceanside, California, 92056, United States
Behavioral Health 2000, LLC
Riverside, California, 92506, United States
nTouch Research
San Diego, California, 92103, United States
Psychiatric Medicine Center
New London, Connecticut, 06320, United States
Glasgow Family Practice
Newark, Delaware, 19702, United States
Leonard Bass, MD, PA
Fort Lauderdale, Florida, 33311, United States
Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
Roger Miller, MD
Jacksonville, Florida, 32257, United States
BioQuan Research Group, Inc.
North Miami, Florida, 33161, United States
Family Practice - St. Cloud
Saint Cloud, Florida, 34769, United States
Allan B. Aven, MD
Arlington Heights, Illinois, 60005, United States
nTouch Research - Chicago
Naperville, Illinois, 60542, United States
nTouch Research - Peoria
Peoria, Illinois, 61602, United States
Balanced Health Research Center
Peoria, Illinois, 61614, United States
American Health Network
Avon, Indiana, 46123, United States
Research Solutions - Evansville
Evansville, Indiana, 47714, United States
Amy Kaissar, MD
Indianapolis, Indiana, 46260, United States
Clinco
Terre Haute, Indiana, 47802, United States
Hartford Research Group
Florence, Kentucky, 41042, United States
New Orleans Medical Institute
Metairie, Louisiana, 70001, United States
Brentwood Research Institute
Shreveport, Louisiana, 71101, United States
Professional Clinical Research at Great Lakes Family Care
Cadillac, Michigan, 49601, United States
Sam Hawatmeh, MD, PC
St Louis, Missouri, 63125, United States
Alliance Medical Center, PC
Alliance, Nebraska, 69301, United States
Clinical Trial Associates
Glendora, New Jersey, 08029, United States
Partners in Primary Care
Turnersville, New Jersey, 08012, United States
ABQ Med., P.C.
Albuquerque, New Mexico, 81709, United States
Eastside Comprehensive Medical Services, LLC
New York, New York, 10021, United States
Raleigh Medical Group
Raleigh, North Carolina, 27609, United States
Salem Research Group
Winston-Salem, North Carolina, 27103, United States
Community Health Care, Inc.
Canal Fulton, Ohio, 44614, United States
Community Research Management Associates, Inc.
Cincinnati, Ohio, 45219, United States
Hightop Medical Research Center
Cincinnati, Ohio, 45224, United States
CFP Research, Inc.
Cincinnati, Ohio, 45242, United States
Martin Schear, MD
Dayton, Ohio, 45406, United States
Family Practice Center of Wadsworth
Wadsworth, Ohio, 44281, United States
Sooner Clinical Research
Edmond, Oklahoma, 73013, United States
Med-line Research
Moore, Oklahoma, 73160, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73120, United States
Advanced Clinical Trials
Eugene, Oregon, 97401, United States
Clinical Research Consultants/Providence Medical
Medford, Oregon, 97504, United States
Medford Medical Clinic, LLP
Medford, Oregon, 97504, United States
Gateway Medical
Downingtown, Pennsylvania, 19335, United States
Feasterville Family Health Care
Feasterville, Pennsylvania, 19053, United States
Detweiler Family Medicine
Lansdale, Pennsylvania, 19446, United States
Green & Seidner Family Practice
Lansdale, Pennsylvania, 19466, United States
Woodburne Family Practice
Levittown, Pennsylvania, 19057, United States
Pearl Clinical Research
Norristown, Pennsylvania, 19401, United States
Joseph Rybicki, MD
Philadelphia, Pennsylvania, 19152, United States
Clinical Trials Research Services, LLC
Pittsburgh, Pennsylvania, 15206, United States
Consolidated Clinical Trials, Inc.
Pittsburgh, Pennsylvania, 15221, United States
Charles Buttz, MD
Pottstown, Pennsylvania, 19465, United States
Research Across America
Reading, Pennsylvania, 19606, United States
The Family Practice
Greer, South Carolina, 29651, United States
Harmony Clinical Research
Johnson City, Tennessee, 37601, United States
DiscoveResearch, Inc.
Beaumont, Texas, 77701, United States
South Texas Applied Research
Corpus Christi, Texas, 78411, United States
International Clinical Research Associates, LLC
Richmond, Virginia, 23294, United States
International Clinical Research Associates
Virgina Beach, Virginia, 23452, United States
Richard Neiman, MD
Kirkland, Washington, 98034, United States
Daniel Blizzard, MD
Spokane, Washington, 99216, United States
Related Publications (2)
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: 23849714DERIVEDMahmoud 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.
PMID: 17975181DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 1, 2004
First Posted
November 1, 2004
Study Start
October 1, 2004
Study Completion
November 1, 2005
Last Updated
December 6, 2011
Record last verified: 2011-12