Status:
COMPLETED
Risperidone and Suicidality in Major Depressive Disorder
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Janssen Pharmaceuticals
Conditions:
Depression
Eligibility:
All Genders
19-60 years
Phase:
PHASE3
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 disord...
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 Neuropsychia...
Eligibility Criteria
Inclusion
- 19-60 years of age
- Diagnosis of major depressive disorder, currently severe with suicidality
- A total score of Montgomery-Asberg Depression Rating Scale (MADRS) =/\> 25 with the suicide sub-score =/\> 4
- Currently is taking an antidepressant at a therapeutic dose for longer than 3 weeks
- In good physical health
Exclusion
- Depression without suicidality
- Presence of major psychiatric conditions other than major depressive disorder, such as bipolar disorder, schizophrenia, or anxiety disorders (except for generalized anxiety disorder)
- Depressive symptoms induced by alcohol or substance abuse
- Psychotic features which are predominant at the initial evaluation
- Unstable major medical illness, such as cardiac disease or diabetes
- Female subjects who are pregnant, breastfeeding, or, if of child-bearing potential, unwilling to use adequate birth control measures
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00167154
Start Date
June 1 2004
End Date
August 1 2008
Last Update
June 10 2021
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294