DepressionPhase 3NCT00863291
A Double-Blind Study of Buprenorphine Treatment of Acute Suicidality
A Phase 3 study testing buprenorphine in people with Depression and Suicidal Ideation, run by Abarbanel Mental Health Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression, Suicidal Ideation, Suicidal Action
- What is being tested?
- buprenorphine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2007to Nov 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- depression
Who cannot join
- substance or alcohol abuse
- psychosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Depression, Suicidal Ideation, Suicidal Action
- Being tested
- buprenorphine, placebo
- Keywords
- Depression, suicidality, buprenorphine
- Medical subject headings
- Depression, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
buprenorphineDrug
Also called Subotex
buprenorphine (range = 0.2-1.6 mg/day, starting dose = 0.2 mg/day, N = 20)
placeboDrug
Placebo in a manner similar to the active comparator
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | buprenorphine (range = 0.2-1.6 mg/day, starting dose = 0.2 mg/day, N = 20) Receives: Drug: buprenorphine |
| 2 | Placebo comparator | Placebo given in a manner similar to he active comparator Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in suicidality as expressed by the score on the Beck Suicidal Ideation Scale
Measured: 2 weeks
Secondary outcomes (1)
Reduction in psychache as measured by the OMMP
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study startNov 2007
- Study completionNov 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abarbanel Mental Health Center
- Sponsor type
- Other government
- Collaborators
- Ministry of Health, Israel
- Investigators
- Yoram Yovel, MD, PHD, Study chair, Haifa University, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863291
- Sponsor's protocol ID
- HFDR-001-07
- Status last verified
- Mar 2009
- First submitted
- 15 Mar 2009
- Last updated
- 17 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Panksepp J. Neuroscience. Feeling the pain of social loss. Science. 2003 Oct 10;302(5643):237-9. doi: 10.1126/science.1091062.
PubMed 14551424
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of the Effects of Buprenophine as Add-on Treatment to Antidepressants in Treating Acutely Suicidal Depressed Inpatients
- ClinicalTrials.gov ID
- NCT00863291
- Acronym / sponsor ID
- HFDR-001-07
- Conditions
- Depression, Suicidal Ideation, Suicidal Action
- Keywords
- Depression, suicidality, buprenorphine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Abarbanel Mental Health CenterOther government
- Collaborators
- Ministry of Health, Israel
- Study start
- Nov 2007
- Study completion
- Nov 2008 (estimated)
- First posted
- 17 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: buprenorphinebuprenorphine (range = 0.2-1.6 mg/day, starting dose = 0.2 mg/day, N = 20) |
| 2 | Placebo comparator | Drug: placeboPlacebo given in a manner similar to he active comparator |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- depression
Key exclusion criteria (2 listed)
- substance or alcohol abuse
- psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| buprenorphineAlso: Subotexbuprenorphine (range = 0.2-1.6 mg/day, starting dose = 0.2 mg/day, N = 20) | Drug | 1 |
| placeboPlacebo in a manner similar to the active comparator | Drug | 2 |
Primary outcome
Reduction in suicidality as expressed by the score on the Beck Suicidal Ideation Scale
Time frame: 2 weeks
1 secondary outcome
Reduction in psychache as measured by the OMMP
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2009.
- Background: PubMed 14551424Panksepp J. Neuroscience. Feeling the pain of social loss. Science. 2003 Oct 10;302(5643):237-9. doi: 10.1126/science.1091062.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoram Yovel, MD, PHD study chair
Haifa University, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing buprenorphine in people with Depression and Suicidal Ideation, run by Abarbanel Mental Health Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in suicidality as expressed by the score on the Beck Suicidal Ideation Scale (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00863291, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2009.