Clinical Study to Determine if Ecopipam Can Reduce Urges to Gamble

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ecopipam Treatment of Pathological Gambling

Conditions
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Pathological Gambling

Intervention / Treatment
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* Drug: Ecopipam


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ecopipam<br>Ecopipam is a selective antagonist of one the classes of dopamine receptor. | Drug: Ecopipam<br>* 50mg tablets<br>* Other names: SCH 39166;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type, Frequency and Severity of Side Effects | All side effects of the drug will be monitored and recorded | 6 weeks | 
| Statistically Significant Changes in the Gambling Symptom Assessment Scale | It is expected that there will be decreases in this scale | 6 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pathological Gambling, ecopipam, Dopamine