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Risperidone and Suicidality in Major Depressive Disorder

This study has been completed.
Janssen Pharmaceuticals
Information provided by (Responsible Party):
Bobbie May, University of Alabama at Birmingham Identifier:
First received: September 10, 2005
Last updated: March 15, 2012
Last verified: March 2012

September 10, 2005
March 15, 2012
June 2004
April 2007   (final data collection date for primary outcome measure)
CGI [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Clinical Global Impression
Not Provided
Complete list of historical versions of study NCT00167154 on Archive Site
MADRS [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Montgomery Asberg Depression Rating Scale
Not Provided
Not Provided
Not Provided
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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):1228-336.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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
19 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
F030929002, RIS-DED-402
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