A Double-Blind Study of Buprenorphine Treatment of Acute Suicidality

Phase 3

• Conditions: Depression; Suicidal Ideation; Suicidal Action
• Interventions: Drug: buprenorphine; Drug: placebo

• Registration Number: NCT00863291
• Lead Sponsor: Abarbanel Mental Health Center

Brief Summary

The acutely suicidal patient presents a complex and dangerous clinical dilemma. Many suicidal patients receive antidepressant medications, but the onset of action of these medications is at least three weeks, and despite their established antidepressant effect, they have not shown a clear anti-suicidal benefit. Psychoanalysts hypothesized that depression (often leading to suicidality) shares important characteristics with the psychological sequellae of object loss and separation distress. Endogenous opioids (endorphines) have been implicated in mediating social bonding and separation distress in mammals. Anecdotal evidence and several clinical studies found the mixed opioid agonist-antagonist buprenorphine to be an effective antidepressant with a rapid onset of action. It is therefore hypothesized that buprenorphine may be a novel and quick-acting treatment for acute suicidality, especially in the context of depression. The proposed double-blind study will examine the effect of buprenorphine on acutely suicidal inpatients. Depression, suicidality, and overall functioning will be assessed before, during and after a two-week buprenorphine/placebo trial. A small subgroup of patients will also be treated with short-term psychoanalytic psychotherapy throughout the study period. It is hypothesized that subjects who receive the active drug will show rapid improvements in objective and subjective measures of suicidality and depression.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study Completion: 2008-11
• Status Verified: 2009-03
• Study First Submitted: 2009-03-15
• Study First Submitted QC: 2009-03-16
• Last Update Submitted: 2009-03-16
• Study First Posted: 2009-03-17
• Last Update Posted: 2009-03-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• depression

Exclusion Criteria

• substance or alcohol abuse
• psychosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	buprenorphine	buprenorphine (range = 0.2-1.6 mg/day, starting dose = 0.2 mg/day, N = 20)
2	placebo	Placebo given in a manner similar to he active comparator

Primary Outcome Measures

Name	Time	Method
Reduction in suicidality as expressed by the score on the Beck Suicidal Ideation Scale	2 weeks

Secondary Outcome Measures

Name	Time	Method
Reduction in psychache as measured by the OMMP	2 weeks

Trial Locations

Locations (1)

Abarbanel MHC; 🇮🇱 Bat-Yam, Israel