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A Study of Nopan Treatment of Acute Suicidality

Phase 3 Study of the Effects of Nopan as add-on Treatment to Antidepressants in Treating Depression and Suicidality

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01046851
Enrollment
60
Registered
2010-01-12
Start date
2008-09-30
Completion date
2011-12-31
Last updated
2012-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicidality

Brief 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. 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.

Interventions

DRUGNopan

Nopan(0.2-1.6 mg/day, starting dose=0.2 mg/day, N=40)

DRUGPlacebo

Placebo in a manner similar to the active comparator

Sponsors

University of Haifa
CollaboratorOTHER
Prof. Yoram Yovell
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* suicidal behavior or ideation (BSI\>6)

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frame
Reduction in Suicidality as expressed by the score on the BSI4 weeks

Secondary

MeasureTime frame
Reduction in depression as measured by the BDI4 weeks

Countries

Israel

Contacts

Primary ContactYoram Yovell, MD, PhD
isan@research.haifa.ac.il972-4-8249910

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026