A Double-Blind Study of Buprenorphine Treatment of Acute Suicidality
Recruitment status was Active, not recruiting
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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 |
- Reduction in suicidality as expressed by the score on the Beck Suicidal Ideation Scale [ Time Frame: 2 weeks ]
- 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 |
Inclusion Criteria:
- depression
Exclusion Criteria:
- substance or alcohol abuse
- psychosis
Contacts and Locations
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 May 21, 2013