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| Name | Class |
|---|---|
| Psyadon Pharma | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ecopipam | Experimental | Ecopipam is a selective antagonist of one the classes of dopamine receptor. |
|
| Placebo | Placebo Comparator | Placebo given first week of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ecopipam | Drug | 50mg tablets |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Statistically Significant (p<0.05) Decrease From Baseline in Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling | 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. | Baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Type, Frequency and Severity of Side Effects | All side effects of the drug will be monitored and recorded | 6 weeks |
| Statistically Significant Changes in the Gambling Symptom Assessment Scale | It is expected that there will be decreases in this scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States | ||
| Yale University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25166480 | Derived | 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. |
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See exclusion criteria
Recruitment started Sept 2010 and finished June 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Ecopipam (50 or 100 mg, as Needed) | Patients were instructed to take a 50 mg tablet each time they had an urge to gamble. If that was ineffective, they were instructed to take a second 50 mg tablet. If that was ineffective, they were not allowed to increase the dose further. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ecopipam 50 or 100 mg, as Needed | Patients were instructed to take a 50 mg tablet of ecopipam when they had an urge to gamble. If no effect, then they could take a second 50 mg tablet. If still no effect, they were not permitted to take any more ecopipam. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Statistically Significant (p<0.05) Decrease From Baseline in Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling | 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. | Patients completing all visits | Posted | Mean | Standard Deviation | YBOCS score | Baseline and 6 weeks |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ecopipam 50 or 100 mg, as Needed | Patients were instructed to take a 50 mg tablet of ecopipam when they had an urge to gamble. If no effect, then they could take a second 50 mg tablet. If still no effect, they were not permitted to take any more ecopipam. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sedation | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
This was an open label trial of ecopipam for the treatment of pathological gambling. A significant effect of drug treatment was demonstrated. These data need to be verified with a double-blind, placebo controlled trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richard Chipkin | Psyadon Pharmaceuticals | 301-919-2020 | rchipkin@psyadonrx.com |
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| ID | Term |
|---|---|
| D005715 | Gambling |
| ID | Term |
|---|---|
| D012309 | Risk-Taking |
| D001519 | Behavior |
| D007174 | Disruptive, Impulse Control, and Conduct Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C058081 | ecopipam |
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| 6 weeks |
| Effects on the Clinical Global Impression | Clinician's Global Impression is used assess severity and changes in clinical symptoms during and at the end of the study | 6 weeks |
| New Haven |
| Connecticut |
| 06519 |
| United States |
| Carver College of Medicine, University of Iowa | Iowa City | Iowa | 52242 | United States |
| University of Minnesota School of Medicine | Minneapolis | Minnesota | 55454 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Type, Frequency and Severity of Side Effects | All side effects of the drug will be monitored and recorded | Not Posted | 6 weeks | Participants |
| Secondary | Statistically Significant Changes in the Gambling Symptom Assessment Scale | It is expected that there will be decreases in this scale | Not Posted | 6 weeks | Participants |
| Secondary | Effects on the Clinical Global Impression | Clinician's Global Impression is used assess severity and changes in clinical symptoms during and at the end of the study | Not Posted | 6 weeks | Participants |
| 0 |
| 34 |
| 13 |
| 34 |
| Anxiety | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Rhinorrhea | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
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