A Double-Blind Study of Buprenorphine Treatment of Acute Suicidality

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00863291
• Other study ID #: HFDR-001-07
• Status: Active, not recruiting
• Phase: Phase 3
• First received: March 15, 2009
• Last updated: March 16, 2009
• Start date: November 2007
• Est. completion date: November 2008

Study information

• Verified date: March 2009
• Source: Abarbanel Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• depression

Exclusion Criteria:

• substance or alcohol abuse

• psychosis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Suicidal Action
• Suicidal Ideation

Intervention

Drug:
• buprenorphine
buprenorphine (range = 0.2-1.6 mg/day, starting dose = 0.2 mg/day, N = 20)
• placebo
Placebo in a manner similar to the active comparator

Locations

Country	Name	City	State
Israel	Abarbanel MHC	Bat-Yam

Sponsors (2)

Lead Sponsor	Collaborator
Abarbanel Mental Health Center	Ministry of Health, Israel

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Panksepp J. Neuroscience. Feeling the pain of social loss. Science. 2003 Oct 10;302(5643):237-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in suicidality as expressed by the score on the Beck Suicidal Ideation Scale		2 weeks
Secondary	Reduction in psychache as measured by the OMMP		2 weeks