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A Study of Nopan Treatment of Acute Suicidality

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by University of Haifa.
Recruitment status was:  Recruiting
University of Haifa
Information provided by (Responsible Party):
Prof. Yoram Yovell, University of Haifa Identifier:
First received: January 11, 2010
Last updated: December 31, 2011
Last verified: December 2011
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.

Condition Intervention Phase
Drug: Nopan
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3 Study of the Effects of Nopan as add-on Treatment to Antidepressants in Treating Depression and Suicidality

Further study details as provided by University of Haifa:

Primary Outcome Measures:
  • Reduction in Suicidality as expressed by the score on the BSI [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Reduction in depression as measured by the BDI [ Time Frame: 4 weeks ]

Estimated Enrollment: 60
Study Start Date: September 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nopan Drug: Nopan
Nopan(0.2-1.6 mg/day, starting dose=0.2 mg/day, N=40)
Other Name: Subotex
Placebo Comparator: Placebo Drug: Placebo
Placebo in a manner similar to the active comparator


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01046851

Contact: Yoram Yovell, MD, PhD 972-4-8249910

Abarbanel MHC Recruiting
Bat-Yam, Israel
Contact: Gali Bar, MA   
Principal Investigator: Mordechai Masiah, MD         
Edith Wolfson Medical Center Recruiting
Holon, Israel
Contact: Gali Bar, MA   
Principal Investigator: Jack Asherov, MD         
Brill Community Mental Health Center Recruiting
Tel Aviv, Israel
Contact: Nathaniel Laor, MD, PhD, Director    972-3-5720808      
Principal Investigator: Nathaniel Laor, MD, PhD, Director         
Sponsors and Collaborators
Prof. Yoram Yovell
University of Haifa
Study Chair: Yoram Yovell, MD, PhD University of Haifa, Institute for the Study of Affective Neuroscience
Principal Investigator: 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
  More Information

Responsible Party: Prof. Yoram Yovell, MD, PhD, University of Haifa Identifier: NCT01046851     History of Changes
Other Study ID Numbers: ISAN-001-09
Study First Received: January 11, 2010
Last Updated: December 31, 2011 processed this record on March 29, 2017