A Double-Blind Study of Buprenorphine Treatment of Acute Suicidality

NCT ID: NCT00863291

Last Updated: 2009-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2008-11-30

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.

Conditions

Depression; Suicidal Ideation; Suicidal Action

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

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

Group Type: ACTIVE_COMPARATOR

buprenorphine

Intervention Type: DRUG

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

2

Placebo given in a manner similar to he active comparator

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Placebo in a manner similar to the active comparator

Interventions

buprenorphine

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

Intervention Type: DRUG

placebo

Placebo in a manner similar to the active comparator

Intervention Type: DRUG

Other Intervention Names

Subotex

Eligibility Criteria

Inclusion Criteria

• depression

Exclusion Criteria

• substance or alcohol abuse
• psychosis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Israel

OTHER_GOV

Sponsor Role: collaborator

Abarbanel Mental Health Center

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Yoram Yovel, MD, PHD

Role: STUDY_CHAIR

Haifa University, Israel

Locations

Abarbanel MHC

Bat Yam, , Israel

Countries

Israel

References

Panksepp J. Neuroscience. Feeling the pain of social loss. Science. 2003 Oct 10;302(5643):237-9. doi: 10.1126/science.1091062.

Reference Type: BACKGROUND

PMID: 14551424 (View on PubMed)

Other Identifiers

HFDR-001-07

Identifier Type: -

Identifier Source: org_study_id