A Double-Blind Study of Buprenorphine Treatment of Acute Suicidality
This trial is active, not recruiting.
|Conditions||depression, suicidal ideation, suicidal action|
|Sponsor||Abarbanel Mental Health Center|
|Collaborator||Ministry of Health, Israel|
|Start date||November 2007|
|End date||November 2008|
|Trial size||40 participants|
|Trial identifier||NCT00863291, HFDR-001-07|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (caregiver, investigator, outcomes assessor)|
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
Male or female participants from 18 years up to 60 years old.
Inclusion Criteria: - depression Exclusion Criteria: - substance or alcohol abuse - psychosis
|Official title||Phase 3 Study of the Effects of Buprenophine as Add-on Treatment to Antidepressants in Treating Acutely Suicidal Depressed Inpatients|
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