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Risperidone Augmentation Therapy in Patients Who Have Failed or Only Partially Responded to a Trial of Antidepressant

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by Rhode Island Hospital.
Recruitment status was:  Active, not recruiting
Janssen Pharmaceutica N.V., Belgium
Emory University
Information provided by:
Rhode Island Hospital Identifier:
First received: September 9, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
The purpose of this study is to assess the safety and efficacy of risperidone augmentation in patients who have failed to respond or only partially responded to an adequate trial of an antidepressant.

Condition Intervention Phase
Major Depression
Drug: Risperidone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Risperidone Augmentation Therapy in Patients Who Have Failed or Only Partially Responded to an Adequate Trial of Antidepressant

Resource links provided by NLM:

Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • Depression symptoms,change score on MADRS scale at 4 weeks
  • Group differences on HRS-D scores
  • Group differences on remission and improvement

Secondary Outcome Measures:
  • Between group differences on quality-of-life measures
  • Group differences of anxiety and psychosocial factors

Estimated Enrollment: 84
Study Start Date: February 2003
Estimated Study Completion Date: February 2005
Detailed Description:

Specific Aims: The goal of this study was to assess the safety and efficacy of risperidone augmentation in patients with major depression who failed to respond, or only partially responded, to an adequate trial of an antidepressant medication. Patients who met this criteria received adjunctive risperidone (1- 3 mg.) for an additional four-week treatment trial.

Subject Population: A total sample of 84 patients completed the study at two sites (Rhode Island Hospital/Brown University, n=42, Emory University, n=42).

Methods/Design: Patients who met criteria for unipolar depression and failed to respond, or partially responded, to an adequate trial of antidepressant medication were randomized to risperidone or a placebo for an additional 4 week treatment trial while continuing on the same dose of their antidepressant medication. Randomization was at a 2:1 ratio of risperidone to placebo.

Data Analysis: Patient outcome (recovery status) of the two treatment conditions were compared using a MADRS rating < 10 to denote remission while improvement was defined as a 50% decrease from baseline to end of study. Odds ratio were examined to see if risperidone augmentation significantly affected the chance of recovery from depression at the end of 4 weeks of treatment.


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

Inclusion Criteria:

  • patients with major depression or partially remitted depression
  • currently receiving an adequate trial of an antidepressant

Exclusion Criteria:

  • diagnosis of bipolar I or bipolar II disorder
  • psychotic features
  • substance dependence or abuse in the past three months
  Contacts and Locations
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Please refer to this study by its identifier: NCT00174577

United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30329
United States, Rhode Island
Mood Disorders Program - Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
Janssen Pharmaceutica N.V., Belgium
Emory University
Principal Investigator: Gabor I Keitner, M.D. Rhode Island Hospital/Brown University
  More Information Identifier: NCT00174577     History of Changes
Other Study ID Numbers: RIS-Dep-402
Study First Received: September 9, 2005
Last Updated: September 9, 2005

Additional relevant MeSH terms:
Depressive Disorder, Major
Depressive Disorder
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Dopamine Antagonists
Dopamine Agents processed this record on May 23, 2017