Clinical trial NCT00174577: Risperidone Augmentation Therapy in Patients Who Have Failed or Only Partially Responded to a Trial of Antidepressant
Official title: Risperidone Augmentation Therapy in Patients Who Have Failed or Only Partially Responded to an Adequate Trial of Antidepressant
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Major Depression
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: Janssen Pharmaceutica N.V., Belgium
name: Emory University
First posted: 2005-09-15
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Depression symptoms,change score on MADRS scale at 4 weeks
measure: Group differences on HRS-D scores
measure: Group differences on remission and improvement
Secondary outcomes:
measure: Between group differences on quality-of-life measures
measure: Group differences of anxiety and psychosocial factors
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Providence
country: United States
facility: Mood Disorders Program - Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital/Brown University
name: Gabor I Keitner, M.D.
role: PRINCIPAL_INVESTIGATOR
References: