Pathological Gambling
Conditions
Keywords
Pathological Gambling, ecopipam, Dopamine
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.
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.
Interventions
DRUGEcopipam
50mg tablets
Sponsors
Psyadon Pharma
Emalex Biosciences Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Statistically Significant (p<0.05) Decrease From Baseline in Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling | 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
| Measure | Time frame | Description |
|---|---|---|
| Type, Frequency and Severity of Side Effects | 6 weeks | All side effects of the drug will be monitored and recorded |
| Statistically Significant Changes in the Gambling Symptom Assessment Scale | 6 weeks | It is expected that there will be decreases in this scale |
| Effects on the Clinical Global Impression | 6 weeks | Clinician's Global Impression is used assess severity and changes in clinical symptoms during and at the end of the study |
Countries
United States
Participant flow
Recruitment details
Recruitment started Sept 2010 and finished June 2011
Pre-assignment details
See exclusion criteria
Participants by arm
| Arm | Count |
|---|---|
| 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. | 34 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 9 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Ecopipam 50 or 100 mg, as Needed |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants |
| Age, Continuous | 44.8 years STANDARD_DEVIATION 13.35 |
| Region of Enrollment United States | 34 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 13 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
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.
Time frame: Baseline and 6 weeks
Population: Patients completing all visits
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ecopipam 50 mg or 100 mg as Needed | Statistically Significant (p<0.05) Decrease From Baseline in Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling | 13.9 YBOCS score | Standard Deviation 8.79 |
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
Time frame: 6 weeks
Secondary
Statistically Significant Changes in the Gambling Symptom Assessment Scale
It is expected that there will be decreases in this scale
Time frame: 6 weeks
Secondary
Type, Frequency and Severity of Side Effects
All side effects of the drug will be monitored and recorded
Time frame: 6 weeks