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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.
 
ClinicalTrials.gov Identifier: NCT00167154
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : June 10, 2021
Sponsor:
Collaborator:
Janssen Pharmaceuticals
Information provided by (Responsible Party):
Roberta 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.

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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
Actual Primary Completion Date : April 2007
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide
Drug Information available for: Risperidone

Arm Intervention/treatment
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




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
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

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


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Janssen Pharmaceuticals
Investigators
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Principal Investigator: Xiaohua Li, MD, PhD University of Alabama at Birmingham
Publications of Results:
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Responsible Party: Roberta May, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00167154    
Other Study ID Numbers: F030929002
RIS-DED-402
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: June 10, 2021
Last Verified: June 2021
Keywords provided by Roberta May, University of Alabama at Birmingham:
suicidality
antipsychotic
antidepressant
treatment
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Suicidal Ideation
Behavioral Symptoms
Mood Disorders
Mental Disorders
Suicide
Self-Injurious Behavior
Risperidone
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