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A Double-Blind Study of Buprenorphine Treatment of Acute Suicidality

Phase 3 Study of the Effects of Buprenophine as Add-on Treatment to Antidepressants in Treating Acutely Suicidal Depressed Inpatients

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00863291
Enrollment
40
Registered
2009-03-17
Start date
2007-11-30
Completion date
2008-11-30
Last updated
2009-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Suicidal Action, Suicidal Ideation

Keywords

Depression, suicidality, buprenorphine

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.

Interventions

DRUGbuprenorphine

buprenorphine (range = 0.2-1.6 mg/day, starting dose = 0.2 mg/day, N = 20)

DRUGplacebo

Placebo in a manner similar to the active comparator

Sponsors

Ministry of Health, Israel
CollaboratorOTHER_GOV
Abarbanel Mental Health Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* depression

Exclusion criteria

* substance or alcohol abuse * psychosis

Design outcomes

Primary

MeasureTime frame
Reduction in suicidality as expressed by the score on the Beck Suicidal Ideation Scale2 weeks

Secondary

MeasureTime frame
Reduction in psychache as measured by the OMMP2 weeks

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026