Risperidone and Suicidality in Major Depressive Disorder

June 8, 2021 updated by: Roberta May, University of Alabama at Birmingham

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CGI
Time Frame: 8 weeks
Clinical Global Impression
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MADRS
Time Frame: 8 weeks
Montgomery Asberg Depression Rating Scale
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

Janssen Pharmaceuticals

Investigators

  • Principal Investigator: Xiaohua Li, MD, PhD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

September 10, 2005

First Submitted That Met QC Criteria

September 10, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Actual)

June 10, 2021

Last Update Submitted That Met QC Criteria

June 8, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F030929002
  • RIS-DED-402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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