A Double-Blind Study of Buprenorphine Treatment of Acute Suicidality
Primary Purpose
Depression, Suicidal Ideation, Suicidal Action
Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
buprenorphine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, suicidality, buprenorphine
Eligibility Criteria
Inclusion Criteria:
- depression
Exclusion Criteria:
- substance or alcohol abuse
- psychosis
Sites / Locations
- Abarbanel MHC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
buprenorphine (range = 0.2-1.6 mg/day, starting dose = 0.2 mg/day, N = 20)
Placebo given in a manner similar to he active comparator
Outcomes
Primary Outcome Measures
Reduction in suicidality as expressed by the score on the Beck Suicidal Ideation Scale
Secondary Outcome Measures
Reduction in psychache as measured by the OMMP
Full Information
NCT ID
NCT00863291
First Posted
March 15, 2009
Last Updated
March 16, 2009
Sponsor
Abarbanel Mental Health Center
Collaborators
Ministry of Health, Israel
1. Study Identification
Unique Protocol Identification Number
NCT00863291
Brief Title
A Double-Blind Study of Buprenorphine Treatment of Acute Suicidality
Official Title
Phase 3 Study of the Effects of Buprenophine as Add-on Treatment to Antidepressants in Treating Acutely Suicidal Depressed Inpatients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Abarbanel Mental Health Center
Collaborators
Ministry of Health, Israel
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Suicidal Ideation, Suicidal Action
Keywords
Depression, suicidality, buprenorphine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
buprenorphine (range = 0.2-1.6 mg/day, starting dose = 0.2 mg/day, N = 20)
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo given in a manner similar to he active comparator
Intervention Type
Drug
Intervention Name(s)
buprenorphine
Other Intervention Name(s)
Subotex
Intervention Description
buprenorphine (range = 0.2-1.6 mg/day, starting dose = 0.2 mg/day, N = 20)
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo in a manner similar to the active comparator
Primary Outcome Measure Information:
Title
Reduction in suicidality as expressed by the score on the Beck Suicidal Ideation Scale
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Reduction in psychache as measured by the OMMP
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
depression
Exclusion Criteria:
substance or alcohol abuse
psychosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoram Yovel, MD, PHD
Organizational Affiliation
Haifa University, Israel
Official's Role
Study Chair
Facility Information:
Facility Name
Abarbanel MHC
City
Bat-Yam
ZIP/Postal Code
59100
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
14551424
Citation
Panksepp J. Neuroscience. Feeling the pain of social loss. Science. 2003 Oct 10;302(5643):237-9. doi: 10.1126/science.1091062.
Results Reference
background
Learn more about this trial
A Double-Blind Study of Buprenorphine Treatment of Acute Suicidality
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