Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00095134
Recruitment Status : Completed
First Posted : November 1, 2004
Last Update Posted : December 6, 2011
Janssen, LP
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: risperidone Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 630 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy
Study Start Date : October 2004
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Risperidone
U.S. FDA Resources

Primary Outcome Measures :
  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 Outcome Measures :
  1. Safety will be assessed through reported adverse events and vital signs (weight, blood pressure, pulse, and temperature).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00095134

  Hide Study Locations
United States, Alabama
Innovative Clinical Trials, LLC
Birmingham, Alabama, United States, 35205
Greystone Medical Research
Birmingham, Alabama, United States, 35242
United States, Arizona
Scottsdale Family Health
Scottsdale, Arizona, United States, 85251
Sun Valley Medical
Sun City, Arizona, United States, 85351
Southwest Biomedical Research Foundation
Tucson, Arizona, United States, 85711
United States, California
Southwestern Research Institute
Burbank, California, United States, 91506
Chrishard Clinical Research
Inglewood, California, United States, 90301
Optimum Health Services
La Mesa, California, United States, 91942
Pacific Insititute for Medical Research
Los Angeles, California, United States, 90024
Optimum Health Services
Oceanside, California, United States, 92056
Behavioral Health 2000, LLC
Riverside, California, United States, 92506
nTouch Research
San Diego, California, United States, 92103
United States, Connecticut
Psychiatric Medicine Center
New London, Connecticut, United States, 06320
United States, Delaware
Glasgow Family Practice
Newark, Delaware, United States, 19702
United States, Florida
Leonard Bass, MD, PA
Ft. Lauderdale, Florida, United States, 33311
Sarkis Clinical Trials
Gainesville, Florida, United States, 32607
Roger Miller, MD
Jacksonville, Florida, United States, 32257
BioQuan Research Group, Inc.
North Miami, Florida, United States, 33161
Family Practice - St. Cloud
St. Cloud, Florida, United States, 34769
United States, Illinois
Allan B. Aven, MD
Arlington Heights, Illinois, United States, 60005
nTouch Research - Chicago
Naperville, Illinois, United States, 60542
nTouch Research - Peoria
Peoria, Illinois, United States, 61602
Balanced Health Research Center
Peoria, Illinois, United States, 61614
United States, Indiana
American Health Network
Avon, Indiana, United States, 46123
Research Solutions - Evansville
Evansville, Indiana, United States, 47714
Amy Kaissar, MD
Indianapolis, Indiana, United States, 46260
Terre Haute, Indiana, United States, 47802
United States, Kentucky
Hartford Research Group
Florence, Kentucky, United States, 41042
United States, Louisiana
New Orleans Medical Institute
Metairie, Louisiana, United States, 70001
Brentwood Research Institute
Shreveport, Louisiana, United States, 71101
United States, Michigan
Professional Clinical Research at Great Lakes Family Care
Cadillac, Michigan, United States, 49601
United States, Missouri
Sam Hawatmeh, MD, PC
St. Louis, Missouri, United States, 63125
United States, Nebraska
Alliance Medical Center, PC
Alliance, Nebraska, United States, 69301
United States, New Jersey
Clinical Trial Associates
Glendora, New Jersey, United States, 08029
Partners in Primary Care
Turnersville, New Jersey, United States, 08012
United States, New Mexico
ABQ Med., P.C.
Albuquerque, New Mexico, United States, 81709
United States, New York
Eastside Comprehensive Medical Services, LLC
New York, New York, United States, 10021
United States, North Carolina
Raleigh Medical Group
Raleigh, North Carolina, United States, 27609
Salem Research Group
Winston Salem, North Carolina, United States, 27103
United States, Ohio
Community Health Care, Inc.
Canal Fulton, Ohio, United States, 44614
Community Research Management Associates, Inc.
Cincinnati, Ohio, United States, 45219
Hightop Medical Research Center
Cincinnati, Ohio, United States, 45224
CFP Research, Inc.
Cincinnati, Ohio, United States, 45242
Martin Schear, MD
Dayton, Ohio, United States, 45406
Family Practice Center of Wadsworth
Wadsworth, Ohio, United States, 44281
United States, Oklahoma
Sooner Clinical Research
Edmond, Oklahoma, United States, 73013
Med-line Research
Moore, Oklahoma, United States, 73160
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
Advanced Clinical Trials
Eugene, Oregon, United States, 97401
Clinical Research Consultants/Providence Medical
Medford, Oregon, United States, 97504
Medford Medical Clinic, LLP
Medford, Oregon, United States, 97504
United States, Pennsylvania
Gateway Medical
Downingtown, Pennsylvania, United States, 19335
Feasterville Family Health Care
Feasterville, Pennsylvania, United States, 19053
Detweiler Family Medicine
Lansdale, Pennsylvania, United States, 19446
Green & Seidner Family Practice
Lansdale, Pennsylvania, United States, 19466
Woodburne Family Practice
Levittown, Pennsylvania, United States, 19057
Pearl Clinical Research
Norristown, Pennsylvania, United States, 19401
Joseph Rybicki, MD
Philadelphia, Pennsylvania, United States, 19152
Clinical Trials Research Services, LLC
Pittsburgh, Pennsylvania, United States, 15206
Consolidated Clinical Trials, Inc.
Pittsburgh, Pennsylvania, United States, 15221
Charles Buttz, MD
Pottstown, Pennsylvania, United States, 19465
Research Across America
Reading, Pennsylvania, United States, 19606
United States, South Carolina
The Family Practice
Greer, South Carolina, United States, 29651
United States, Tennessee
Harmony Clinical Research
Johnson City, Tennessee, United States, 37601
United States, Texas
DiscoveResearch, Inc.
Beaumont, Texas, United States, 77701
South Texas Applied Research
Corpus Christi, Texas, United States, 78411
United States, Virginia
International Clinical Research Associates, LLC
Richmond, Virginia, United States, 23294
International Clinical Research Associates
Virgina Beach, Virginia, United States, 23452
United States, Washington
Richard Neiman, MD
Kirkland, Washington, United States, 98034
Daniel Blizzard, MD
Spokane, Washington, United States, 99216
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Janssen, LP

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00095134     History of Changes
Other Study ID Numbers: CR004726
First Posted: November 1, 2004    Key Record Dates
Last Update Posted: December 6, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents