A Double-Blind Study of Buprenorphine Treatment of Acute Suicidality

NCT00863291 | Unknown Phase 3 DMC

• 1 other identifier: HFDR-001-07
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Depression; suicidality; buprenorphine

Outcome Measures

Primary Outcomes (1)

• Reduction in suicidality as expressed by the score on the Beck Suicidal Ideation Scale

  2 weeks

Secondary Outcomes (1)

• Reduction in psychache as measured by the OMMP

  2 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

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

Drug: buprenorphine

2

PLACEBO COMPARATOR

Placebo given in a manner similar to he active comparator

Drug: placebo

Interventions

buprenorphine DRUG

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

Also known as: Subotex

1

placebo DRUG

Placebo in a manner similar to the active comparator

2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• depression

You may not qualify if:

• substance or alcohol abuse
• psychosis

Sponsors & Collaborators

• Abarbanel Mental Health Center: lead
• Ministry of Health, Israel: collaborator

Study Sites (1)

Abarbanel MHC

Bat Yam, 59100, Israel

Location

Related Publications (1)

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

  PMID: 14551424 BACKGROUND

MeSH Terms

Conditions

Depression; Suicidal Ideation

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Suicide; Self-Injurious Behavior

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Yoram Yovel, MD, PHD

  Haifa University, Israel

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 15, 2009
• First Posted: March 17, 2009
• Study Start: November 1, 2007
• Study Completion: November 1, 2008
• Last Updated: March 17, 2009

Record last verified: 2009-03

Locations

IL (1)