Risperidone and Suicidality in Major Depressive Disorder - Tabular View

Tracking Information

First Received Date ^ICMJE

September 10, 2005

Last Updated Date

February 3, 2009

Start Date ^ICMJE

June 2004

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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.

Change History

Complete list of historical versions of study NCT00167154 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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 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.

Descriptive Information

Brief Title ^ICMJE

Risperidone and Suicidality in Major Depressive Disorder

Official Title ^ICMJE

Efficacy of Risperidone in the Management of Suicidality in Major Depressive Disorder

Brief Summary

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.

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Depression

Intervention ^ICMJE

Drug: risperidone

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

August 2008

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

19 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00167154

Responsible Party

Study ID Numbers ^ICMJE

F030929002, RIS-DED-402

Study Sponsor ^ICMJE

University of Alabama at Birmingham

Collaborators ^ICMJE

Janssen Pharmaceuticals

Investigators ^ICMJE

Principal Investigator:

Xiaohua Li, MD, PhD

University of Alabama at Birmingham

Information Provided By

University of Alabama at Birmingham

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP