Overview

This trial is active, not recruiting.

Conditions depression, suicidal ideation, suicidal action
Treatments buprenorphine, placebo
Phase phase 3
Sponsor Abarbanel Mental Health Center
Collaborator Ministry of Health, Israel
Start date November 2007
End date November 2008
Trial size 40 participants
Trial identifier NCT00863291, HFDR-001-07

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
buprenorphine (range = 0.2-1.6 mg/day, starting dose = 0.2 mg/day, N = 20)
buprenorphine Subotex
buprenorphine (range = 0.2-1.6 mg/day, starting dose = 0.2 mg/day, N = 20)
(Placebo Comparator)
Placebo given in a manner similar to he active comparator
placebo
Placebo in a manner similar to the active comparator

Primary Outcomes

Measure
Reduction in suicidality as expressed by the score on the Beck Suicidal Ideation Scale
time frame: 2 weeks

Secondary Outcomes

Measure
Reduction in psychache as measured by the OMMP
time frame: 2 weeks

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: - depression Exclusion Criteria: - substance or alcohol abuse - psychosis

Additional Information

Official title Phase 3 Study of the Effects of Buprenophine as Add-on Treatment to Antidepressants in Treating Acutely Suicidal Depressed Inpatients
Trial information was received from ClinicalTrials.gov and was last updated in March 2009.
Information provided to ClinicalTrials.gov by Abarbanel Mental Health Center.