Clinical Study to Determine if Ecopipam Can Reduce Urges to Gamble
This study has been completed.
Sponsor:
Psyadon Pharma
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
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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:
|
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
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 Sch 39166 Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on June 17, 2013