A Double-Blind Study of Buprenorphine Treatment of Acute Suicidality

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00863291
Recruitment Status : Unknown
Verified March 2009 by Abarbanel Mental Health Center.
Recruitment status was:  Active, not recruiting
First Posted : March 17, 2009
Last Update Posted : March 17, 2009
Ministry of Health, Israel
Information provided by:
Abarbanel Mental Health Center

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.

Condition or disease Intervention/treatment Phase
Depression Suicidal Ideation Suicidal Action Drug: buprenorphine Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3 Study of the Effects of Buprenophine as Add-on Treatment to Antidepressants in Treating Acutely Suicidal Depressed Inpatients
Study Start Date : November 2007
Estimated Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Active Comparator: 1
buprenorphine (range = 0.2-1.6 mg/day, starting dose = 0.2 mg/day, N = 20)
Drug: buprenorphine
buprenorphine (range = 0.2-1.6 mg/day, starting dose = 0.2 mg/day, N = 20)
Other Name: Subotex

Placebo Comparator: 2
Placebo given in a manner similar to he active comparator
Drug: placebo
Placebo in a manner similar to the active comparator

Primary Outcome Measures :
  1. Reduction in suicidality as expressed by the score on the Beck Suicidal Ideation Scale [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Reduction in psychache as measured by the OMMP [ Time Frame: 2 weeks ]

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • depression

Exclusion Criteria:

  • substance or alcohol abuse
  • psychosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00863291

Abarbanel MHC
Bat-Yam, Israel, 59100
Sponsors and Collaborators
Abarbanel Mental Health Center
Ministry of Health, Israel
Study Chair: Yoram Yovel, MD, PHD Haifa University, Israel

Publications: Identifier: NCT00863291     History of Changes
Other Study ID Numbers: HFDR-001-07
First Posted: March 17, 2009    Key Record Dates
Last Update Posted: March 17, 2009
Last Verified: March 2009

Keywords provided by Abarbanel Mental Health Center:

Additional relevant MeSH terms:
Suicidal Ideation
Behavioral Symptoms
Self-Injurious Behavior
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists