Major Depressive Disorder Clinical Trial
Official title:
A Double-Blind Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy
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.
Status | Completed |
Enrollment | 630 |
Est. completion date | November 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | ABQ Med., P.C. | Albuquerque | New Mexico |
United States | Alliance Medical Center, PC | Alliance | Nebraska |
United States | Allan B. Aven, MD | Arlington Heights | Illinois |
United States | American Health Network | Avon | Indiana |
United States | DiscoveResearch, Inc. | Beaumont | Texas |
United States | Greystone Medical Research | Birmingham | Alabama |
United States | Innovative Clinical Trials, LLC | Birmingham | Alabama |
United States | Southwestern Research Institute | Burbank | California |
United States | Professional Clinical Research at Great Lakes Family Care | Cadillac | Michigan |
United States | Community Health Care, Inc. | Canal Fulton | Ohio |
United States | CFP Research, Inc. | Cincinnati | Ohio |
United States | Community Research Management Associates, Inc. | Cincinnati | Ohio |
United States | Hightop Medical Research Center | Cincinnati | Ohio |
United States | South Texas Applied Research | Corpus Christi | Texas |
United States | Martin Schear, MD | Dayton | Ohio |
United States | Gateway Medical | Downingtown | Pennsylvania |
United States | Sooner Clinical Research | Edmond | Oklahoma |
United States | Advanced Clinical Trials | Eugene | Oregon |
United States | Research Solutions - Evansville | Evansville | Indiana |
United States | Feasterville Family Health Care | Feasterville | Pennsylvania |
United States | Hartford Research Group | Florence | Kentucky |
United States | Leonard Bass, MD, PA | Ft. Lauderdale | Florida |
United States | Sarkis Clinical Trials | Gainesville | Florida |
United States | Clinical Trial Associates | Glendora | New Jersey |
United States | The Family Practice | Greer | South Carolina |
United States | Amy Kaissar, MD | Indianapolis | Indiana |
United States | Chrishard Clinical Research | Inglewood | California |
United States | Roger Miller, MD | Jacksonville | Florida |
United States | Harmony Clinical Research | Johnson City | Tennessee |
United States | Richard Neiman, MD | Kirkland | Washington |
United States | Optimum Health Services | La Mesa | California |
United States | Detweiler Family Medicine | Lansdale | Pennsylvania |
United States | Green & Seidner Family Practice | Lansdale | Pennsylvania |
United States | Woodburne Family Practice | Levittown | Pennsylvania |
United States | Pacific Insititute for Medical Research | Los Angeles | California |
United States | Clinical Research Consultants/Providence Medical | Medford | Oregon |
United States | Medford Medical Clinic, LLP | Medford | Oregon |
United States | New Orleans Medical Institute | Metairie | Louisiana |
United States | Med-line Research | Moore | Oklahoma |
United States | nTouch Research - Chicago | Naperville | Illinois |
United States | Psychiatric Medicine Center | New London | Connecticut |
United States | Eastside Comprehensive Medical Services, LLC | New York | New York |
United States | Glasgow Family Practice | Newark | Delaware |
United States | Pearl Clinical Research | Norristown | Pennsylvania |
United States | BioQuan Research Group, Inc. | North Miami | Florida |
United States | Optimum Health Services | Oceanside | California |
United States | Cutting Edge Research Group | Oklahoma City | Oklahoma |
United States | Balanced Health Research Center | Peoria | Illinois |
United States | nTouch Research - Peoria | Peoria | Illinois |
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 | Raleigh Medical Group | Raleigh | North Carolina |
United States | Research Across America | Reading | Pennsylvania |
United States | International Clinical Research Associates, LLC | Richmond | Virginia |
United States | Behavioral Health 2000, LLC | Riverside | California |
United States | nTouch Research | San Diego | California |
United States | Scottsdale Family Health | Scottsdale | Arizona |
United States | Brentwood Research Institute | Shreveport | Louisiana |
United States | Daniel Blizzard, MD | Spokane | Washington |
United States | Family Practice - St. Cloud | St. Cloud | Florida |
United States | Sam Hawatmeh, MD, PC | St. Louis | Missouri |
United States | Sun Valley Medical | Sun City | Arizona |
United States | Clinco | Terre Haute | Indiana |
United States | Southwest Biomedical Research Foundation | Tucson | Arizona |
United States | Partners in Primary Care | Turnersville | New Jersey |
United States | International Clinical Research Associates | Virgina Beach | Virginia |
United States | Family Practice Center of Wadsworth | Wadsworth | Ohio |
United States | Salem Research Group | Winston Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Janssen, LP |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Safety will be assessed through reported adverse events and vital signs (weight, blood pressure, pulse, and temperature). |
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