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Sponsors and Collaborators: |
Abarbanel Mental Health Center Ministry of Health, Israel |
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Information provided by: | Abarbanel Mental Health Center |
ClinicalTrials.gov Identifier: | NCT00863291 |
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 |
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Depression Suicidal Ideation Suicidal Action |
Drug: buprenorphine Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Phase 3 Study of the Effects of Buprenophine as Add-on Treatment to Antidepressants in Treating Acutely Suicidal Depressed Inpatients |
Estimated Enrollment: | 40 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | November 2008 |
Arms | Assigned Interventions |
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1: Active Comparator
buprenorphine (range = 0.2-1.6 mg/day, starting dose = 0.2 mg/day, N = 20)
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Drug: buprenorphine
buprenorphine (range = 0.2-1.6 mg/day, starting dose = 0.2 mg/day, N = 20)
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2: Placebo Comparator
Placebo given in a manner similar to he active comparator
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Drug: placebo
Placebo in a manner similar to the active comparator
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Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | HFDR-001-07 |
Study First Received: | March 15, 2009 |
Last Updated: | March 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00863291 History of Changes |
Health Authority: | Israel: Ministry of Health |
Depression suicidality buprenorphine |
Depression Narcotic Antagonists Central Nervous System Depressants Narcotics Depressive Disorder Behavioral Symptoms Buprenorphine |
Mental Disorders Mood Disorders Analgesics Peripheral Nervous System Agents Antidepressive Agents Analgesics, Opioid |
Depression Narcotic Antagonists Physiological Effects of Drugs Central Nervous System Depressants Narcotics Depressive Disorder Pharmacologic Actions Behavioral Symptoms Buprenorphine |
Mental Disorders Sensory System Agents Therapeutic Uses Mood Disorders Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |