Risperidone and Suicidality in Major Depressive Disorder

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborator: Janssen Pharmaceuticals
• Treatments: Risperidone

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