Risperidone and Suicidality in Major Depressive Disorder

Completed · Phase 3 · Has a placebo group

Conditions studied: Depression

In brief

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.

Key facts

Study ID

NCT00167154

Run by

University of Alabama at Birmingham

People needed

30

Starts

2004-06-01

Expected to finish

2008-08-01

Last updated by the study team

2021-06-10

Who can join

Age: 19 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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