A Study of Nopan Treatment of Acute Suicidality

NCT01046851 | Unknown Phase 3 DMC

• 1 other identifier: ISAN-001-09
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Suicidality

Outcome Measures

Primary Outcomes (1)

• Reduction in Suicidality as expressed by the score on the BSI

  4 weeks

Secondary Outcomes (1)

• Reduction in depression as measured by the BDI

  4 weeks

Study Arms (2)

Nopan

ACTIVE COMPARATOR

Drug: Nopan

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Nopan DRUG

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

Also known as: Subotex

Nopan

Placebo DRUG

Placebo in a manner similar to the active comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• suicidal behavior or ideation (BSI\>6)

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Prof. Yoram Yovell: lead
• University of Haifa: collaborator

Study Sites (3)

Abarbanel MHC

Bat Yam, Israel

RECRUITING

Edith Wolfson Medical Center

Holon, Israel

RECRUITING

Brill Community Mental Health Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Yoram Yovell, MD, PhD

  University of Haifa, Institute for the Study of Affective Neuroscience

  STUDY CHAIR

• Mordechai Masiah, MD

  Abarbanel MHC

  PRINCIPAL INVESTIGATOR

• Jack Asherov, MD

  Edith Wolfson Medical Center

  PRINCIPAL INVESTIGATOR

• Nathaniel Laor, MD, PhD, Director

  Tel Aviv- Brill Community Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoram Yovell, MD, PhD

CONTACT

972-4-8249910; isan@research.haifa.ac.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: January 12, 2010
• Study Start: September 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 4, 2012

Record last verified: 2011-12

Locations

IL (3)