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A Study of Nopan Treatment of Acute Suicidality

Primary Purpose

Suicidality

Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Nopan
Placebo
Sponsored by
Prof. Yoram Yovell
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicidality

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Abarbanel MHCRecruiting
  • Edith Wolfson Medical CenterRecruiting
  • Brill Community Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nopan

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Reduction in Suicidality as expressed by the score on the BSI

Secondary Outcome Measures

Reduction in depression as measured by the BDI

Full Information

First Posted
January 11, 2010
Last Updated
December 31, 2011
Sponsor
Prof. Yoram Yovell
Collaborators
University of Haifa
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1. Study Identification

Unique Protocol Identification Number
NCT01046851
Brief Title
A Study of Nopan Treatment of Acute Suicidality
Official Title
Phase 3 Study of the Effects of Nopan as add-on Treatment to Antidepressants in Treating Depression and Suicidality
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Yoram Yovell
Collaborators
University of Haifa

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidality

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nopan
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Nopan
Other Intervention Name(s)
Subotex
Intervention Description
Nopan(0.2-1.6 mg/day, starting dose=0.2 mg/day, N=40)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo in a manner similar to the active comparator
Primary Outcome Measure Information:
Title
Reduction in Suicidality as expressed by the score on the BSI
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Reduction in depression as measured by the BDI
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yoram Yovell, MD, PhD
Phone
972-4-8249910
Email
isan@research.haifa.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoram Yovell, MD, PhD
Organizational Affiliation
University of Haifa, Institute for the Study of Affective Neuroscience
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mordechai Masiah, MD
Organizational Affiliation
Abarbanel MHC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jack Asherov, MD
Organizational Affiliation
Edith Wolfson Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nathaniel Laor, MD, PhD, Director
Organizational Affiliation
Tel Aviv- Brill Community Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abarbanel MHC
City
Bat-Yam
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gali Bar, MA
Email
galibar@bezeqint.net
First Name & Middle Initial & Last Name & Degree
Mordechai Masiah, MD
Facility Name
Edith Wolfson Medical Center
City
Holon
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gali Bar, MA
Email
galibar@bezeqint.net
First Name & Middle Initial & Last Name & Degree
Jack Asherov, MD
Facility Name
Brill Community Mental Health Center
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathaniel Laor, MD, PhD, Director
Phone
972-3-5720808
First Name & Middle Initial & Last Name & Degree
Nathaniel Laor, MD, PhD, Director

12. IPD Sharing Statement

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A Study of Nopan Treatment of Acute Suicidality

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