Clinical trial NCT00167154: Risperidone and Suicidality in Major Depressive Disorder
Official title: Efficacy of Risperidone in the Management of Suicidality in Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Keywords: suicidality
antipsychotic
antidepressant
treatment
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Janssen Pharmaceuticals
First posted: 2005-09-14
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: CGI
timeFrame: 8 weeks
Secondary outcomes:
measure: MADRS
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Xiaohua Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reeves H, Batra S, May RS, Zhang R, Dahl DC, Li X. Efficacy of risperidone augmentation to antidepressants in the management of suicidality in major depressive disorder: a randomized, double-blind, placebo-controlled pilot study. J Clin Psychiatry. 2008 Aug;69(8):1228-1236. doi: 10.4088/jcp.v69n0805.