- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00863291
A Double-Blind Study of Buprenorphine Treatment of Acute Suicidality
March 16, 2009 updated by: Abarbanel Mental Health Center
Phase 3 Study of the Effects of Buprenophine as Add-on Treatment to Antidepressants in Treating Acutely Suicidal Depressed Inpatients
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bat-Yam, Israel, 59100
- Abarbanel MHC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- depression
Exclusion Criteria:
- substance or alcohol abuse
- psychosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
buprenorphine (range = 0.2-1.6 mg/day, starting dose = 0.2 mg/day, N = 20)
|
buprenorphine (range = 0.2-1.6 mg/day, starting dose = 0.2 mg/day, N = 20)
Other Names:
|
Placebo Comparator: 2
Placebo given in a manner similar to he active comparator
|
Placebo in a manner similar to the active comparator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction in suicidality as expressed by the score on the Beck Suicidal Ideation Scale
Time Frame: 2 weeks
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction in psychache as measured by the OMMP
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Yoram Yovel, MD, PHD, Haifa University, Israel
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion
December 7, 2022
Study Completion (Anticipated)
November 1, 2008
Study Registration Dates
First Submitted
March 15, 2009
First Submitted That Met QC Criteria
March 16, 2009
First Posted (Estimate)
March 17, 2009
Study Record Updates
Last Update Posted (Estimate)
March 17, 2009
Last Update Submitted That Met QC Criteria
March 16, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HFDR-001-07
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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