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

Major Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00174577
• Other study ID #: RIS-Dep-402
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: September 9, 2005
• Start date: February 2003
• Est. completion date: February 2005

Study information

• Verified date: September 2005
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depressive Disorder, Major
• Major Depression

Intervention

Drug:
• Risperidone

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Mood Disorders Program - Rhode Island Hospital	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
Rhode Island Hospital	Emory University, Janssen Pharmaceutica N.V., Belgium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression symptoms,change score on MADRS scale at 4 weeks
Primary	Group differences on HRS-D scores
Primary	Group differences on remission and improvement
Secondary	Between group differences on quality-of-life measures
Secondary	Group differences of anxiety and psychosocial factors