A Study of Nopan Treatment of Acute Suicidality

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by University of Haifa.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Haifa
Information provided by (Responsible Party):
Prof. Yoram Yovell, University of Haifa
ClinicalTrials.gov Identifier:
NCT01046851
First received: January 11, 2010
Last updated: December 31, 2011
Last verified: December 2011
  Purpose

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
Suicidality
Drug: Nopan
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in depression as measured by the BDI [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01046851

Contacts
Contact: Yoram Yovell, MD, PhD 972-4-8249910 isan@research.haifa.ac.il

Locations
Israel
Abarbanel MHC Recruiting
Bat-Yam, Israel
Contact: Gali Bar, MA       galibar@bezeqint.net   
Principal Investigator: Mordechai Masiah, MD         
Edith Wolfson Medical Center Recruiting
Holon, Israel
Contact: Gali Bar, MA       galibar@bezeqint.net   
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
Investigators
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

No publications provided

Responsible Party: Prof. Yoram Yovell, MD, PhD, University of Haifa
ClinicalTrials.gov Identifier: NCT01046851     History of Changes
Other Study ID Numbers: ISAN-001-09
Study First Received: January 11, 2010
Last Updated: December 31, 2011
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on September 22, 2014