Clinical Study to Determine if Ecopipam Can Reduce Urges to Gamble

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Psyadon Pharma
ClinicalTrials.gov Identifier:
NCT01215357
First received: October 4, 2010
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Pathological Gambling
Drug: Ecopipam
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Ecopipam Treatment of Pathological Gambling

Resource links provided by NLM:


Further study details as provided by Psyadon Pharma:

Primary Outcome Measures:
  • Statistically Significant (p<0.05) Decrease From Baseline in Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    All side effects of the drug will be monitored and recorded

  • Statistically Significant Changes in the Gambling Symptom Assessment Scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    It is expected that there will be decreases in this scale

  • Effects on the Clinical Global Impression [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Clinician's Global Impression is used assess severity and changes in clinical symptoms during and at the end of the study


Enrollment: 34
Study Start Date: October 2010
Study Completion Date: August 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ecopipam
Ecopipam is a selective antagonist of one the classes of dopamine receptor.
Drug: Ecopipam
50mg tablets
Other Names:
  • PSYRX101
  • SCH 39166

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01215357

Locations
United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06519
United States, Iowa
Carver College of Medicine, University of Iowa
Iowa City, Iowa, United States, 52242
United States, Minnesota
University of Minnesota School of Medicine
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
Psyadon Pharma
Investigators
Principal Investigator: Jon Grant, MD Univ. of Minnesota
Principal Investigator: Donald Black, MD Iowa University
Principal Investigator: Timothy Fong, MD University of California, Los Angeles
Principal Investigator: Marc Potenza, MD Yale University
  More Information

Additional Information:
No publications provided

Responsible Party: Psyadon Pharma
ClinicalTrials.gov Identifier: NCT01215357     History of Changes
Obsolete Identifiers: NCT01198951
Other Study ID Numbers: PSY201
Study First Received: October 4, 2010
Results First Received: December 18, 2012
Last Updated: February 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Psyadon Pharma:
Pathological Gambling
ecopipam
Dopamine

Additional relevant MeSH terms:
Gambling
Impulse Control Disorders
Mental Disorders
Ecopipam
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014