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A Double-Blind Study of Buprenorphine Treatment of Acute Suicidality

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2009 by Abarbanel Mental Health Center.
Recruitment status was:  Active, not recruiting
ClinicalTrials.gov Identifier:
First Posted: March 17, 2009
Last Update Posted: March 17, 2009
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.
Ministry of Health, Israel
Information provided by:
Abarbanel Mental Health Center
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 Intervention Phase
Depression Suicidal Ideation Suicidal Action Drug: buprenorphine Drug: placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Abarbanel Mental Health Center:

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

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

Estimated Enrollment: 40
Study Start Date: November 2007
Estimated Study Completion Date: November 2008
Arms Assigned Interventions
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


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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
  Contacts and Locations
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 ClinicalTrials.gov 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
  More Information

ClinicalTrials.gov Identifier: NCT00863291     History of Changes
Other Study ID Numbers: HFDR-001-07
First Submitted: March 15, 2009
First Posted: March 17, 2009
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