A Study of Nopan Treatment of Acute Suicidality

December 31, 2011 updated by: Prof. Yoram Yovell

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Bat-Yam, Israel
        • Recruiting
        • Abarbanel MHC
        • Contact:
        • Principal Investigator:
          • Mordechai Masiah, MD
      • Holon, Israel
        • Recruiting
        • Edith Wolfson Medical Center
        • Contact:
        • Principal Investigator:
          • Jack Asherov, MD
      • Tel Aviv, Israel
        • Recruiting
        • Brill Community Mental Health Center
        • Contact:
          • Nathaniel Laor, MD, PhD, Director
          • Phone Number: 972-3-5720808
        • Principal Investigator:
          • Nathaniel Laor, MD, PhD, Director

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo in a manner similar to the active comparator
Active Comparator: Nopan
Drug: Nopan
Nopan(0.2-1.6 mg/day, starting dose=0.2 mg/day, N=40)
Other Names:
  • Subotex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in Suicidality as expressed by the score on the BSI
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction in depression as measured by the BDI
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Yoram Yovell

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

January 11, 2010

First Submitted That Met QC Criteria

January 11, 2010

First Posted (Estimate)

January 12, 2010

Study Record Updates

Last Update Posted (Estimate)

January 4, 2012

Last Update Submitted That Met QC Criteria

December 31, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISAN-001-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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