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Completed

NCT Number: NCT01215357

Clinical Study to Determine if Ecopipam Can Reduce Urges to Gamble

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of California, Los Angeles, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ecopipam

Drug

50mg tablets

Other names: PSYRX101, SCH 39166

Primary outcomes

  1. Statistically Significant (p<0.05) Decrease From Baseline in Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling

    Time frame: Baseline and 6 weeks

    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 outcomes

  1. Type, Frequency and Severity of Side Effects

    Time frame: 6 weeks

    All side effects of the drug will be monitored and recorded

  2. Statistically Significant Changes in the Gambling Symptom Assessment Scale

    Time frame: 6 weeks

    It is expected that there will be decreases in this scale

  3. Effects on the Clinical Global Impression

    Time frame: 6 weeks

    Clinician's Global Impression is used assess severity and changes in clinical symptoms during and at the end of the study

Sponsors and collaborators

Lead sponsor

Emalex Biosciences Inc.

Industry

Collaborators

  • Psyadon Pharma

Registry information

Official study title

Ecopipam Treatment of Pathological Gambling

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 6, 2010
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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