A Double-Blind Study of Buprenorphine Treatment of Acute Suicidality

Abarbanel Mental Health Center

Status and phase: Unknown; Phase 3

Conditions: Suicidal Ideation; Depression; Suicidal Action

Treatments: Drug: placebo; Drug: buprenorphine

Study type: Interventional

Funder types: Other

Identifiers

NCT00863291

HFDR-001-07

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• depression

Exclusion criteria

• substance or alcohol abuse
• psychosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

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

Treatment:

Drug: buprenorphine

2

Placebo Comparator group

Description:

Placebo given in a manner similar to he active comparator

Treatment:

Drug: placebo