A Study of Nopan Treatment of Acute Suicidality

Suicidality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01046851
• Other study ID #: ISAN-001-09
• Status: Recruiting
• Phase: Phase 3
• First received: January 11, 2010
• Last updated: December 31, 2011
• Start date: September 2008
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: University of Haifa
• Contact: Yoram Yovell, MD, PhD
• Phone: 972-4-8249910
• Email: isan[@]research.haifa.ac.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Suicidality

Intervention

Drug:
• Nopan
Nopan(0.2-1.6 mg/day, starting dose=0.2 mg/day, N=40)
• Placebo
Placebo in a manner similar to the active comparator

Locations

Country	Name	City	State
Israel	Abarbanel MHC	Bat-Yam
Israel	Edith Wolfson Medical Center	Holon
Israel	Brill Community Mental Health Center	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Prof. Yoram Yovell	University of Haifa

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Suicidality as expressed by the score on the BSI		4 weeks	No
Secondary	Reduction in depression as measured by the BDI		4 weeks	No