A Study of Nopan Treatment of Acute Suicidality | NCT01046851

Studies
A Study of Nopan Treatment of Acute Suicidality

NCT01046851

Sponsor

Prof. Yoram Yovell

Status

Unknown status

Last Update Posted

Jan 4, 2012Estimated

Enrollment

60Estimated

Phase

Phase 3

Conditions

Suicidality

Interventions

Nopan
Placebo

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Dec 2011Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Jan 11, 2010

First Submission Date that Met QC Criteria

Jan 11, 2010

First Posted Date

Jan 12, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 31, 2011

Last Update Posted Date

Jan 4, 2012Estimated

Name	Class
University of Haifa	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nopan	Active Comparator		Drug: Nopan
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nopan	Drug	Nopan(0.2-1.6 mg/day, starting dose=0.2 mg/day, N=40)	Nopan

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yoram Yovell, MD, PhD	Contact	972-4-8249910		isan@research.haifa.ac.il

Overall Officials

Name	Affiliation	Role
Yoram Yovell, MD, PhD	University of Haifa, Institute for the Study of Affective Neuroscience	Study Chair
Mordechai Masiah, MD	Abarbanel MHC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Abarbanel MHC	Recruiting	Bat Yam			Israel

Condition Browse Module

MeSH Terms

ID	Term
D059020	Suicidal Ideation

Ancestor Terms

ID	Term
D013405	Suicide
D016728	Self-Injurious Behavior
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided