Risperidone and Suicidality in Major Depressive Disorder

This study has been completed.
Sponsor:
Collaborator:
Janssen Pharmaceuticals
Information provided by (Responsible Party):
Bobbie May, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00167154
First received: September 10, 2005
Last updated: March 15, 2012
Last verified: March 2012
  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 and placebo comparator
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Risperidone in the Management of Suicidality in Major Depressive Disorder

Resource links provided by NLM:


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

Primary Outcome Measures:
  • CGI [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Clinical Global Impression


Secondary Outcome Measures:
  • MADRS [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Montgomery Asberg Depression Rating Scale


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)
Arms Assigned Interventions
Experimental: risperidone
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

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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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, RIS-DED-402
Study First Received: September 10, 2005
Last Updated: March 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
suicidality
antipsychotic
antidepressant
treatment

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

ClinicalTrials.gov processed this record on August 19, 2014