A Double-Blind Study of Buprenorphine Treatment of Acute Suicidality

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Abarbanel Mental Health Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Ministry of Health, Israel
Information provided by:
Abarbanel Mental Health Center
ClinicalTrials.gov Identifier:
NCT00863291
First received: March 15, 2009
Last updated: March 16, 2009
Last verified: March 2009
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, 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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • depression

Exclusion Criteria:

  • substance or alcohol abuse
  • psychosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00863291

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

Publications:
ClinicalTrials.gov Identifier: NCT00863291     History of Changes
Other Study ID Numbers: HFDR-001-07
Study First Received: March 15, 2009
Last Updated: March 16, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Abarbanel Mental Health Center:
Depression
suicidality
buprenorphine

Additional relevant MeSH terms:
Depression
Depressive Disorder
Suicidal Ideation
Behavioral Symptoms
Mood Disorders
Mental Disorders
Suicide
Self-Injurious Behavior
Buprenorphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on April 17, 2014