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Clinical Study to Determine if Ecopipam Can Reduce Urges to Gamble

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01215357
First Posted: October 6, 2010
Last Update Posted: March 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Psyadon Pharma
October 4, 2010
October 6, 2010
December 18, 2012
February 12, 2013
March 8, 2013
October 2010
May 2012   (Final data collection date for primary outcome measure)
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.
Statistically significant reduction in Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling [ Time Frame: 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.
Complete list of historical versions of study NCT01215357 on ClinicalTrials.gov Archive Site
  • Type, Frequency and Severity of Side Effects [ Time Frame: 6 weeks ]
    All side effects of the drug will be monitored and recorded
  • Statistically Significant Changes in the Gambling Symptom Assessment Scale [ Time Frame: 6 weeks ]
    It is expected that there will be decreases in this scale
  • 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
Same as current
Not Provided
Not Provided
 
Clinical Study to Determine if Ecopipam Can Reduce Urges to Gamble
Ecopipam Treatment of Pathological Gambling
This study is designed to test the hypothesis that ecopipam is able to reduce urges to gamble in patients diagnosed with Pathological Gambling.
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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Pathological Gambling
Drug: Ecopipam
50mg tablets
Other Names:
  • PSYRX101
  • SCH 39166
Experimental: Ecopipam
Ecopipam is a selective antagonist of one the classes of dopamine receptor.
Intervention: Drug: Ecopipam
Grant JE, Odlaug BL, Black DW, Fong T, Davtian M, Chipkin R, Kim SW. A single-blind study of 'as-needed' ecopipam for gambling disorder. Ann Clin Psychiatry. 2014 Aug;26(3):179-86.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
August 2012
May 2012   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01215357
PSY201
No
Not Provided
Not Provided
Psyadon Pharma
Psyadon Pharma
Not Provided
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
Psyadon Pharma
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP