Risperidone and Suicidality in Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00167154
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : March 16, 2012
Janssen Pharmaceuticals
Information provided by (Responsible Party):
Bobbie May, University of Alabama at Birmingham

September 10, 2005
September 14, 2005
March 16, 2012
June 2004
April 2007   (Final data collection date for primary outcome measure)
CGI [ Time Frame: 8 weeks ]
Clinical Global Impression
Not Provided
Complete list of historical versions of study NCT00167154 on Archive Site
MADRS [ Time Frame: 8 weeks ]
Montgomery Asberg Depression Rating Scale
Not Provided
Not Provided
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Risperidone and Suicidality in Major Depressive Disorder
Efficacy of Risperidone in the Management of Suicidality in Major Depressive Disorder
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.
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.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Drug: Risperidone and placebo comparator
Up to 2 mg risperidone or matching placebo daily
  • Experimental: risperidone
    Intervention: Drug: Risperidone and placebo comparator
  • Placebo Comparator: placebo
    placebo comparator
    Intervention: Drug: Risperidone and placebo comparator
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):1228-1236.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
August 2008
April 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 19-60 years of age
  2. Diagnosis of major depressive disorder, currently severe with suicidality
  3. A total score of Montgomery-Asberg Depression Rating Scale (MADRS) =/> 25 with the suicide sub-score =/> 4
  4. Currently is taking an antidepressant at a therapeutic dose for longer than 3 weeks
  5. In good physical health

Exclusion Criteria:

  1. Depression without suicidality
  2. Presence of major psychiatric conditions other than major depressive disorder, such as bipolar disorder, schizophrenia, or anxiety disorders (except for generalized anxiety disorder)
  3. Depressive symptoms induced by alcohol or substance abuse
  4. Psychotic features which are predominant at the initial evaluation
  5. Unstable major medical illness, such as cardiac disease or diabetes
  6. Female subjects who are pregnant, breastfeeding, or, if of child-bearing potential, unwilling to use adequate birth control measures
Sexes Eligible for Study: All
19 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Bobbie May, University of Alabama at Birmingham
University of Alabama at Birmingham
Janssen Pharmaceuticals
Principal Investigator: Xiaohua Li, MD, PhD University of Alabama at Birmingham
University of Alabama at Birmingham
March 2012

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