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Risperidone and Suicidality in Major Depressive Disorder

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ClinicalTrials.gov 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

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.

Condition or disease Intervention/treatment Phase
Depression Drug: Risperidone and placebo comparator Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Risperidone in the Management of Suicidality in Major Depressive Disorder
Study Start Date : June 2004
Primary Completion Date : April 2007
Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Risperidone
U.S. FDA Resources

Arm Intervention/treatment
Experimental: risperidone
Drug: Risperidone and placebo comparator
Up to 2 mg risperidone or matching placebo daily
Placebo Comparator: placebo
placebo comparator
Drug: Risperidone and placebo comparator
Up to 2 mg risperidone or matching placebo daily

Primary Outcome Measures :
  1. CGI [ Time Frame: 8 weeks ]
    Clinical Global Impression

Secondary Outcome Measures :
  1. MADRS [ Time Frame: 8 weeks ]
    Montgomery Asberg Depression Rating Scale

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00167154

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Janssen Pharmaceuticals
Principal Investigator: Xiaohua Li, MD, PhD University of Alabama at Birmingham

Responsible Party: Bobbie May, Director, Office of Psychiatric Research, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00167154     History of Changes
Other Study ID Numbers: F030929002
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: March 16, 2012
Last Verified: March 2012

Keywords provided by Bobbie May, University of Alabama at Birmingham:

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents