Seizure Disorder |
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Clinical Trial: Study Comparing Adjunctive Risperidone versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy
This study is currently recruiting patients.
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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 | Treatment or Intervention | Phase |
|---|---|---|
| Major Depressive Disorder | Drug: risperidone | Phase III |
MedlinePlus related topics: Mental Health
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Double-Blind Study Comparing Adjunctive Risperidone versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy
Expected Total Enrollment: 630
Study start: October 2004; Expected completion: July 2005
Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
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)
Location and Contact Information
Alabama
Innovative Clinical Trials, LLC, Birmingham, Alabama, 35205, United States; Recruiting
Mitchel Touger, MD, Principal Investigator
Greystone Medical Research, Birmingham, Alabama, 35242, United States; Recruiting
David Wilhelm, MD, Principal Investigator
Arizona
Scottsdale Family Health, Scottsdale, Arizona, 85251, United States; Recruiting
Joseph Lillo, DO, Principal Investigator
Sun Valley Medical, Sun City, Arizona, 85351, United States; Recruiting
Satpreet Gill, MD, Principal Investigator
Southwest Biomedical Research Foundation, Tucson, Arizona, 85711, United States; Recruiting
Steven Bupp, MD, Principal Investigator
California
Pacific Insititute for Medical Research, Los Angeles, California, 90024, United States; Recruiting
Tanya Vapnik, MD, Principal Investigator
Behavioral Health 2000, LLC, Riverside, California, 92506, United States; Recruiting
Joachim Raese, MD, Principal Investigator
Southwestern Research Institute, Burbank, California, 91506, United States; Recruiting
Brock Summers, MD, Principal Investigator
Optimum Health Services, Oceanside, California, 92056, United States; Recruiting
Valentin Isacescu, MD, Principal Investigator
Optimum Health Services, La Mesa, California, 91942, United States; Recruiting
Gregory Paniccia, MD, Principal Investigator
nTouch Research, San Diego, California, 92103, United States; Recruiting
William Shapiro, MD, Principal Investigator
Chrishard Clinical Research, Inglewood, California, 90301, United States; Recruiting
Cranford Scott, MD, Principal Investigator
Connecticut
Psychiatric Medicine Center, New London, Connecticut, 06320, United States; Recruiting
Henry Crabbe, MD, Principal Investigator
Delaware
Glasgow Family Practice, Newark, Delaware, 19702, United States; Recruiting
Julio Navarro, MD, Principal Investigator
Florida
Sarkis Clinical Trials, Gainesville, Florida, 32607, United States; Recruiting
Michael Johnson, MD, Principal Investigator
BioQuan Research Group, Inc., North Miami, Florida, 33161, United States; Recruiting
Serge Vilvar, MD, Principal Investigator
Leonard Bass, MD, PA, Ft. Lauderdale, Florida, 33311, United States; Recruiting
Leonard Bass, MD, Principal Investigator
Roger Miller, MD, Jacksonville, Florida, 32257, United States; Recruiting
Roger Miller, MD, Principal Investigator
Family Practice - St. Cloud, St. Cloud, Florida, 34769, United States; Recruiting
Charles Powers, MD, Principal Investigator
Illinois
Allan B. Aven, MD, Arlington Heights, Illinois, 60005, United States; Recruiting
Allan Aven, MD, Principal Investigator
nTouch Research - Peoria, Peoria, Illinois, 61602, United States; Recruiting
Daniel Brune, MD, Principal Investigator
Balanced Health Research Center, Peoria, Illinois, 61614, United States; Recruiting
Rebecca Knight, MD, Principal Investigator
nTouch Research - Chicago, Naperville, Illinois, 60542, United States; Recruiting
James Cunnar, MD, Principal Investigator
Indiana
Amy Kaissar, MD, Indianapolis, Indiana, 46260, United States; Recruiting
Amy Kaissar, MD, Principal Investigator
Research Solutions - Evansville, Evansville, Indiana, 47714, United States; Recruiting
Mohammed Allaw, MD, Principal Investigator
Clinco, Terre Haute, Indiana, 47802, United States; Recruiting
Paras Harshawat, MD, Principal Investigator
American Health Network, Avon, Indiana, 46123, United States; Recruiting
Ronald Stegemoller, MD, Principal Investigator
Kentucky
Hartford Research Group, Florence, Kentucky, 41042, United States; Recruiting
James Hartford, MD, Principal Investigator
Louisiana
Brentwood Research Institute, Shreveport, Louisiana, 71101, United States; Recruiting
Guy Brannon, MD, Principal Investigator
New Orleans Medical Institute, Metairie, Louisiana, 70001, United States; Recruiting
Robert Detrinis, MD, Principal Investigator
Michigan
Professional Clinical Research at Great Lakes Family Care, Cadillac, Michigan, 49601, United States; Recruiting
William George, MD, Principal Investigator
Missouri
Sam Hawatmeh, MD, PC, St. Louis, Missouri, 63125, United States; Recruiting
Humam Farah, MD, Principal Investigator
Nebraska
Alliance Medical Center, PC, Alliance, Nebraska, 69301, United States; Recruiting
Bruce Forney, MD, Principal Investigator
New Jersey
Partners in Primary Care, Turnersville, New Jersey, 08012, United States; Recruiting
Robert Direnzo, MD, Principal Investigator
Clinical Trial Associates, Glendora, New Jersey, 08029, United States; Recruiting
Benjamin Blank, MD, Principal Investigator
New Mexico
ABQ Med., P.C., Albuquerque, New Mexico, 81709, United States; Recruiting
Kristine Bordenave, MD, Principal Investigator
New York
Eastside Comprehensive Medical Services, LLC, New York, New York, 10021, United States; Recruiting
Ram Shrivastava, MD, Principal Investigator
North Carolina
Raleigh Medical Group, Raleigh, North Carolina, 27609, United States; Recruiting
Brian Goldman, MD, Principal Investigator
Salem Research Group, Winston Salem, North Carolina, 27103, United States; Recruiting
Robert Rosen, MD, Principal Investigator
Ohio
Hightop Medical Research Center, Cincinnati, Ohio, 45224, United States; Recruiting
James Fidelholtz, MD, Principal Investigator
Family Practice Center of Wadsworth, Wadsworth, Ohio, 44281, United States; Recruiting
Matthew Finneran, MD, Principal Investigator
Community Health Care, Inc., Canal Fulton, Ohio, 44614, United States; Recruiting
Rodney Ison, MD, Principal Investigator
Community Research Management Associates, Inc., Cincinnati, Ohio, 45219, United States; Recruiting
Alfredo Rivera, MD, Principal Investigator
Martin Schear, MD, Dayton, Ohio, 45406, United States; Recruiting
Martin Schear, MD, Principal Investigator
CFP Research, Inc., Cincinnati, Ohio, 45242, United States; Recruiting
William Cox, MD, Principal Investigator
Oklahoma
Sooner Clinical Research, Edmond, Oklahoma, 73013, United States; Recruiting
Donald Denmark, MD, Principal Investigator
Cutting Edge Research Group, Oklahoma City, Oklahoma, 73120, United States; Recruiting
Willis Holloway, MD, Principal Investigator
Med-line Research, Moore, Oklahoma, 73160, United States; Recruiting
Keith Layne, DO, Principal Investigator
Oregon
Advanced Clinical Trials, Eugene, Oregon, 97401, United States; Recruiting
Marie Buscemi, MD, Principal Investigator
Medford Medical Clinic, LLP, Medford, Oregon, 97504, United States; Recruiting
Edward Cullen, MD, Principal Investigator
Clinical Research Consultants/Providence Medical, Medford, Oregon, 97504, United States; Recruiting
Michael Robinson, MD, Principal Investigator
Pennsylvania
Green & Seidner Family Practice, Lansdale, Pennsylvania, 19466, United States; Recruiting
Michael Seidner, MD, Principal Investigator
Gateway Medical, Downingtown, Pennsylvania, 19335, United States; Recruiting
Geoffrey Burgess, MD, Principal Investigator
Charles Buttz, MD, Pottstown, Pennsylvania, 19465, United States; Recruiting
Charles Buttz, MD, Principal Investigator
Consolidated Clinical Trials, Inc., Pittsburgh, Pennsylvania, 15221, United States; Recruiting
Daniel Crable, MD, Principal Investigator
Pearl Clinical Research, Norristown, Pennsylvania, 19401, United States; Recruiting
Robert Pearlstein, MD, Principal Investigator
Research Across America, Reading, Pennsylvania, 19606, United States; Recruiting
Michael Warren, MD, Principal Investigator
Woodburne Family Practice, Levittown, Pennsylvania, 19057, United States; Recruiting
Christine Zador-Silverman, DO, Principal Investigator
Clinical Trials Research Services, LLC, Pittsburgh, Pennsylvania, 15206, United States; Recruiting
Ben Zimmer, MD, Principal Investigator
Detweiler Family Medicine, Lansdale, Pennsylvania, 19446, United States; Recruiting
Robert Detweiler, MD, Principal Investigator
Joseph Rybicki, MD, Philadelphia, Pennsylvania, 19152, United States; Recruiting
Joseph Rybicki, MD, Principal Investigator
Feasterville Family Health Care, Feasterville, Pennsylvania, 19053, United States; Recruiting
John Penniston, MD, Principal Investigator
South Carolina
The Family Practice, Greer, South Carolina, 29651, United States; Recruiting
Ronald DeGarmo, MD, Principal Investigator
Tennessee
Harmony Clinical Research, Johnson City, Tennessee, 37601, United States; Recruiting
Curtis Kauffmann, MD, Principal Investigator
Texas
DiscoveResearch, Inc., Beaumont, Texas, 77701, United States; Recruiting
Stephen Braden, MD, Principal Investigator
DiscoveResearch, Inc., Beaumont, Texas, 77701, United States; Recruiting
Maria Blahey, MD, Principal Investigator
South Texas Applied Research, Corpus Christi, Texas, 78411, United States; Recruiting
Gerard Boynton, MD, Principal Investigator
Virginia
International Clinical Research Associates, LLC, Richmond, Virginia, 23294, United States; Recruiting
John Gilliam, MD, Principal Investigator
International Clinical Research Associates, VIrgina Beach, Virginia, 23452, United States; Recruiting
William Yetter, MD, Principal Investigator
Washington
Daniel Blizzard, MD, Spokane, Washington, 99216, United States; Recruiting
Daniel Blizzard, MD, Principal Investigator
Richard Neiman, MD, Kirkland, Washington, 98034, United States; Recruiting
Richard Neiman, MD, Principal Investigator
More Information
Record last reviewed: November 2004
Last Updated: November 17, 2004
Record first received: November 1, 2004
ClinicalTrials.gov Identifier: NCT00095134
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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