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

Completed · Phase 3

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT00095134

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

630

Starts

2004-10-01

Expected to finish

2005-11-01

Last updated by the study team

2011-12-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• 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
• Innovative Clinical Trials, LLC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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