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Clinical Study to Determine if Ecopipam Can Reduce Urges to Gamble

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ClinicalTrials.gov Identifier: NCT01215357
Recruitment Status : Completed
First Posted : October 6, 2010
Results First Posted : February 12, 2013
Last Update Posted : March 8, 2013
Sponsor:
Information provided by (Responsible Party):
Psyadon Pharma

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pathological Gambling Drug: Ecopipam Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Ecopipam Treatment of Pathological Gambling
Study Start Date : October 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Ecopipam
Ecopipam is a selective antagonist of one the classes of dopamine receptor.
 Drug: Ecopipam
50mg tablets
Other Names:
  • PSYRX101
  • SCH 39166


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Additional Information:
Psyadon Pharmaceutical's Website  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Psyadon Pharma
ClinicalTrials.gov Identifier: NCT01215357     History of Changes
Obsolete Identifiers: NCT01198951
Other Study ID Numbers: PSY201
First Posted: October 6, 2010    Key Record Dates
Results First Posted: February 12, 2013
Last Update Posted: March 8, 2013
Last Verified: February 2013

Keywords provided by Psyadon Pharma:
Pathological Gambling
ecopipam
Dopamine

Additional relevant MeSH terms:
Gambling
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders
Ecopipam
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
 Physiological Effects of Drugs
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action