Risperidone and Suicidality in Major Depressive Disorder - Full Text View

Sponsor:	University of Alabama at Birmingham
Collaborator:	Janssen Pharmaceuticals
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00167154

Purpose

The purpose of this trial is to investigate the efficacy of risperidone as an adjunct to an antidepressant treatment in the acute management of suicidality during an episode of major depressive disorder.

Condition	Intervention	Phase
Depression	Drug: risperidone	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy of Risperidone in the Management of Suicidality in Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression

Drug Information available for: Risperidone

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:

To investigate the efficacy of risperidone as an adjunct to an antidepressant treatment in the acute management of suicidality during an episode of major depressive disorder

Secondary Outcome Measures:

To assess the efficacy of risperidone as an adjunct to an antidepressant for the improvement of other symptoms of severe depression
To assess the onset of effect, the length of treatment required, and the utilization of a hospital in the treatment of depression with suicidality using risperidone adjunctive to an antidepressant
To assess the efficacy of risperidone as an adjunct to an antidepressant in the improvement of neurocognitive function in depression
To assess the safety and tolerance of risperidone in the treatment of depression with suicidality

Estimated Enrollment:	30
Study Start Date:	June 2004
Study Completion Date:	August 2008
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Detailed Description:

Using a double blind, placebo-controlled design, subjects diagnosed with a current episode of major depressive disorder (defined by DSM-IV criteria and supported by the Mini International Neuropsychiatric Interview), severe with suicidality despite currently taking an antidepressant, will be enrolled in the eight-week study. The treatment will be initiated by randomizing patients to receive risperidone or placebo in addition to the antidepressant that the patient is already taking. The clinical efficacy will be evaluated after 4 days, weekly for 4 weeks, then every other week for 4 weeks with the efficacy measures. During the eight-week study, treatment with risperidone or placebo will continue at the highest effective dosage (up to 2 mg per day). The dose of the antidepressant will not be changed during the study.

Eligibility

Ages Eligible for Study:	19 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

19-60 years of age
Diagnosis of major depressive disorder, currently severe with suicidality
A total score of Montgomery-Asberg Depression Rating Scale (MADRS) =/> 25 with the suicide sub-score =/> 4
Currently is taking an antidepressant at a therapeutic dose for longer than 3 weeks
In good physical health

Exclusion Criteria:

Depression without suicidality
Presence of major psychiatric conditions other than major depressive disorder, such as bipolar disorder, schizophrenia, or anxiety disorders (except for generalized anxiety disorder)
Depressive symptoms induced by alcohol or substance abuse
Psychotic features which are predominant at the initial evaluation
Unstable major medical illness, such as cardiac disease or diabetes
Female subjects who are pregnant, breastfeeding, or, if of child-bearing potential, unwilling to use adequate birth control measures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00167154

Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294

Sponsors and Collaborators

University of Alabama at Birmingham

Janssen Pharmaceuticals

Investigators

Principal Investigator:

Xiaohua Li, MD, PhD

University of Alabama at Birmingham

More Information

Publications:

Reeves H, Batra S, May RS, Zhang R, Dahl DC, Li X. Efficacy of risperidone augmentation to antidepressants in the management of suicidality in major depressive disorder: a randomized, double-blind, placebo-controlled pilot study. J Clin Psychiatry. 2008 Aug;69(8):1228-336.

Study ID Numbers:	F030929002, RIS-DED-402
Study First Received:	September 10, 2005
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00167154 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:

suicidality
antipsychotic
antidepressant
treatment

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Depression
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Risperidone
Central Nervous System Depressants
Dopamine Antagonists
Depressive Disorder, Major
Antipsychotic Agents

Depressive Disorder
Pharmacologic Actions
Behavioral Symptoms
Serotonin Antagonists
Serotonin Agents
Mental Disorders
Therapeutic Uses
Mood Disorders
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2009