Clinical Study to Determine if Ecopipam Can Reduce Urges to Gamble

Pathological Gambling Clinical Trial

Official title:

Ecopipam Treatment of Pathological Gambling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01215357
• Other study ID #: PSY201
• Status: Completed
• Phase: Phase 2
• Start date: October 2010
• Est. completion date: August 2012

Study information

• Verified date: February 2013
• Source: Emalex Biosciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to test the hypothesis that ecopipam is able to reduce urges to gamble in patients diagnosed with Pathological Gambling.

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.

Other known NCT identifiers

• NCT01198951

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Gambling
• Pathological Gambling

Intervention

Drug:
• Ecopipam
50mg tablets

Locations

Country	Name	City	State
United States	Carver College of Medicine, University of Iowa	Iowa City	Iowa
United States	University of California, Los Angeles	Los Angeles	California
United States	University of Minnesota School of Medicine	Minneapolis	Minnesota
United States	Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Emalex Biosciences Inc.	Psyadon Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 6 weeks
Secondary	Type, Frequency and Severity of Side Effects	All side effects of the drug will be monitored and recorded	6 weeks
Secondary	Statistically Significant Changes in the Gambling Symptom Assessment Scale	It is expected that there will be decreases in this scale	6 weeks
Secondary	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	6 weeks

External Links

•   Psyadon Pharmaceutical's Website