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 because the information has not been verified recently.
Verified September 2005 by Rhode Island Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Janssen Pharmaceutica N.V., Belgium
Emory University
Information provided by:
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT00174577
First received: September 9, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174577

Locations
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
Investigators
Principal Investigator: Gabor I Keitner, M.D. Rhode Island Hospital/Brown University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00174577     History of Changes
Other Study ID Numbers: RIS-Dep-402
Study First Received: September 9, 2005
Last Updated: September 9, 2005
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder, Major
Behavioral Symptoms
Depressive Disorder
Mental Disorders
Mood Disorders
Antidepressive Agents
Risperidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014