SuicidalityPhase 3NCT01046851
A Study of Nopan Treatment of Acute Suicidality
A Phase 3 study testing Nopan in people with Suicidality, run by Prof. Yoram Yovell at 3 sites in Israel.
Trial summary
Anecdotal evidence and several clinical studies found the mixed opioid agonist-antagonist Nopan to be an effective antidepressant with a rapid onset of action. It is therefore hypothesized that Nopan may be a novel and quick-acting treatment for acute suicidality. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Suicidality
- What is being tested?
- Nopan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesIsrael
- Study dates
- Sep 2008to Dec 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- suicidal behavior or ideation (BSI>6)
Who cannot join
- ECT history within the last month
- psychotic features within the last 3 months
- history of schizophrenia, substance or alcohol abuse within the last two years
- benzodiazepine dependence within the last two years
- any significant systemic illness or unstable medical condition which does not permit inclusion, according to the research physician
- pregnant women
- patients who currently suffer from severe impairment or severe dysfunction of liver, kidney, adrenal, gall, closed brain injury, urinary retention or respiratory system.
Trial locations and contacts
3 sites in 1 country.
Israel3 sites, 3 recruiting
- Recruiting
Abarbanel MHC
Bat Yam
Gali Bar, MA, galibar@bezeqint.net
Mordechai Masiah, MD
- Recruiting
Edith Wolfson Medical Center
Holon
Gali Bar, MA, galibar@bezeqint.net
Jack Asherov, MD
- Recruiting
Brill Community Mental Health Center
Tel Aviv
Nathaniel Laor, MD, PhD, Director, 972-3-5720808
Nathaniel Laor, MD, PhD, Director
About this study
Official title: Phase 3 Study of the Effects of Nopan as add-on Treatment to Antidepressants in Treating Depression and Suicidality
Anecdotal evidence and several clinical studies found the mixed opioid agonist-antagonist Nopan to be an effective antidepressant with a rapid onset of action. It is therefore hypothesized that Nopan may be a novel and quick-acting treatment for acute suicidality. Depression, suicidality, and overall functioning will be assessed before, during and after a four-week Nopan/placebo trial. It is hypothesized that subjects who receive the active drug will show rapid improvements in objective and subjective measures of these variables.
- Conditions
- Suicidality
- Being tested
- Nopan, Placebo
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NopanDrug
Also called Subotex
Nopan(0.2-1.6 mg/day, starting dose=0.2 mg/day, N=40)
PlaceboDrug
Placebo in a manner similar to the active comparator
| Study group | Role | What they receive |
|---|---|---|
| Nopan | Active comparator | Not described Receives: Drug: Nopan |
| Placebo | Placebo comparator | Not described 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 BSI
Measured: 4 weeks
Secondary outcomes (1)
Reduction in depression as measured by the BDI
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startSep 2008
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicidalityStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Yoram Yovell
- Sponsor type
- University, hospital or other
- Collaborators
- University of Haifa
- Responsible party
- Sponsor-investigator, Prof. Yoram Yovell, University of Haifa
- Investigators
- Yoram Yovell, MD, PhD, Study chair, University of Haifa, Institute for the Study of Affective NeuroscienceMordechai Masiah, MD, Principal investigator, Abarbanel MHCJack Asherov, MD, Principal investigator, Edith Wolfson Medical CenterNathaniel Laor, MD, PhD, Director, Principal investigator, Tel Aviv- Brill Community Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046851
- Sponsor's protocol ID
- ISAN-001-09
- Status last verified
- Dec 2011
- First submitted
- 11 Jan 2010
- Last updated
- 4 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of the Effects of Nopan as add-on Treatment to Antidepressants in Treating Depression and Suicidality
- ClinicalTrials.gov ID
- NCT01046851
- Acronym / sponsor ID
- ISAN-001-09
- Conditions
- Suicidality
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Prof. Yoram YovellUniversity, hospital or other
- Collaborators
- University of Haifa
- Study start
- Sep 2008
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 12 Jan 2010 (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.
Anecdotal evidence and several clinical studies found the mixed opioid agonist-antagonist Nopan to be an effective antidepressant with a rapid onset of action. It is therefore hypothesized that Nopan may be a novel and quick-acting treatment for acute suicidality. Depression, suicidality, and overall functioning will be assessed before, during and after a four-week Nopan/placebo trial. It is hypothesized that subjects who receive the active drug will show rapid improvements in objective and subjective measures of these variables.
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 |
|---|---|---|
| Nopan | Active comparator | Drug: Nopan |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- suicidal behavior or ideation (BSI>6)
Key exclusion criteria (7 listed)
- ECT history within the last month
- psychotic features within the last 3 months
- history of schizophrenia, substance or alcohol abuse within the last two years
- benzodiazepine dependence within the last two years
- any significant systemic illness or unstable medical condition which does not permit inclusion, according to the research physician
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 |
|---|---|---|
| NopanAlso: SubotexNopan(0.2-1.6 mg/day, starting dose=0.2 mg/day, N=40) | Drug | Nopan |
| PlaceboPlacebo in a manner similar to the active comparator | Drug | Placebo |
Primary outcome
Reduction in Suicidality as expressed by the score on the BSI
Time frame: 4 weeks
1 secondary outcome
Reduction in depression as measured by the BDI
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2012.
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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 Yovell, MD, PhD study chair
University of Haifa, Institute for the Study of Affective Neuroscience
Mordechai Masiah, MD principal investigator
Abarbanel MHC
Jack Asherov, MD principal investigator
Edith Wolfson Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nopan in people with Suicidality, run by Prof. Yoram Yovell at 3 sites 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 7 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 4 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Contact Yoram Yovell, MD, PhD (972-4-8249910, isan@research.haifa.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Suicidality as expressed by the score on the BSI (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jan 2012.