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Clinical Study to Determine if Ecopipam Can Reduce Urges to Gamble

Primary Purpose

Pathological Gambling

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ecopipam
Sponsored by
Psyadon Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pathological Gambling focused on measuring Pathological Gambling, ecopipam, Dopamine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject must be diagnosed with Pathological Gambling according to DSMIV criteria
  • Subject must have at least 2 episodes of gambling behavior within the previous 2 weeks before screening
  • Subject must have gambling urges of at least moderate intensity

Exclusion Criteria:

  • Subjects must not have unstable medical illness or clinically significant abnormalities on lab tests, ECG, or physical exam
  • Subjects with major depressive episode within the last 2 years
  • Subjects with a history of attempted suicide
  • Subjects with first degree relative with major depressive episode that resulted in hospitalization, attempted or completed suicide
  • Subjects with a history of epilepsy or seizures
  • Subjects with a myocardial infarction (heart attack) with in the last 6 months
  • Subjects with a lifetime history of bipolar disorder, dementia, schizophrenia, or any psychotic disorder
  • Subjects with current of recent DSM-IV diagnosis of substance abuse or dependence (with the exception of nicotine)

Sites / Locations

  • University of California, Los Angeles
  • Yale University
  • Carver College of Medicine, University of Iowa
  • University of Minnesota School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ecopipam

Arm Description

Ecopipam is a selective antagonist of one the classes of dopamine receptor.

Outcomes

Primary Outcome Measures

Statistically Significant (p<0.05) Decrease From Baseline in Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling
This scale assesses the severity of gambling urges and gambling behaviors. The study anticipates that there will be a reduction in either or both of these assessments. The range is from a minimum of 0 to a maximum of 40, where zero means no gambling urges occurred.

Secondary Outcome Measures

Type, Frequency and Severity of Side Effects
All side effects of the drug will be monitored and recorded
Statistically Significant Changes in the Gambling Symptom Assessment Scale
It is expected that there will be decreases in this scale
Effects on the Clinical Global Impression
Clinician's Global Impression is used assess severity and changes in clinical symptoms during and at the end of the study

Full Information

First Posted
October 4, 2010
Last Updated
February 28, 2013
Sponsor
Psyadon Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01215357
Brief Title
Clinical Study to Determine if Ecopipam Can Reduce Urges to Gamble
Official Title
Ecopipam Treatment of Pathological Gambling
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Psyadon Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to test the hypothesis that ecopipam is able to reduce urges to gamble in patients diagnosed with Pathological Gambling.
Detailed Description
The purpose of this study is to determine if ecopipam is able to stop urges to gamble in patients diagnosed with Pathological Gambling. Nerves communicate with each other by releasing chemicals called "neurotransmitters". One of these neurotransmitters in the brain is called "dopamine". After dopamine is released by the nerve it "talks" to other nerves by interacting with receptors that are unique to that neurotransmitter. Ecopipam is a drug that selectively blocks one family of dopamine receptors. Some scientists believe that the urge to gamble is related to having too much dopamine in the brain. By blocking the receptors that dopamine uses, ecopipam may be able to relieve the urge to gamble.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pathological Gambling
Keywords
Pathological Gambling, ecopipam, Dopamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ecopipam
Arm Type
Experimental
Arm Description
Ecopipam is a selective antagonist of one the classes of dopamine receptor.
Intervention Type
Drug
Intervention Name(s)
Ecopipam
Other Intervention Name(s)
PSYRX101, SCH 39166
Intervention Description
50mg tablets
Primary Outcome Measure Information:
Title
Statistically Significant (p<0.05) Decrease From Baseline in Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling
Description
This scale assesses the severity of gambling urges and gambling behaviors. The study anticipates that there will be a reduction in either or both of these assessments. The range is from a minimum of 0 to a maximum of 40, where zero means no gambling urges occurred.
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Type, Frequency and Severity of Side Effects
Description
All side effects of the drug will be monitored and recorded
Time Frame
6 weeks
Title
Statistically Significant Changes in the Gambling Symptom Assessment Scale
Description
It is expected that there will be decreases in this scale
Time Frame
6 weeks
Title
Effects on the Clinical Global Impression
Description
Clinician's Global Impression is used assess severity and changes in clinical symptoms during and at the end of the study
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject must be diagnosed with Pathological Gambling according to DSMIV criteria Subject must have at least 2 episodes of gambling behavior within the previous 2 weeks before screening Subject must have gambling urges of at least moderate intensity Exclusion Criteria: Subjects must not have unstable medical illness or clinically significant abnormalities on lab tests, ECG, or physical exam Subjects with major depressive episode within the last 2 years Subjects with a history of attempted suicide Subjects with first degree relative with major depressive episode that resulted in hospitalization, attempted or completed suicide Subjects with a history of epilepsy or seizures Subjects with a myocardial infarction (heart attack) with in the last 6 months Subjects with a lifetime history of bipolar disorder, dementia, schizophrenia, or any psychotic disorder Subjects with current of recent DSM-IV diagnosis of substance abuse or dependence (with the exception of nicotine)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Grant, MD
Organizational Affiliation
Univ. of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Donald Black, MD
Organizational Affiliation
Iowa University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Timothy Fong, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marc Potenza, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Carver College of Medicine, University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Minnesota School of Medicine
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25166480
Citation
Grant JE, Odlaug BL, Black DW, Fong T, Davtian M, Chipkin R, Kim SW. A single-blind study of 'as-needed' ecopipam for gambling disorder. Ann Clin Psychiatry. 2014 Aug;26(3):179-86.
Results Reference
derived
Links:
URL
http://www.psyadonrx.com
Description
Psyadon Pharmaceutical's Website

Learn more about this trial

Clinical Study to Determine if Ecopipam Can Reduce Urges to Gamble

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