Phase 2
Completed N=34
Clinical Study to Determine if Ecopipam Can Reduce Urges to Gamble
Pathological Gambling
Source: ClinicalTrials.gov NCT01215357 ↗
Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcomePrimary: Statistically Significant (p<0.05) Decrease From Baseline in Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling — 13.9 YBOCS score
Summary
This study is designed to test the hypothesis that ecopipam is able to reduce urges to gamble in patients diagnosed with Pathological Gambling.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Statistically Significant (p<0.05) Decrease From Baseline in Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling |
13.9 | — |
| SECONDARY Type, Frequency and Severity of Side Effects |
— | — |
| SECONDARY Statistically Significant Changes in the Gambling Symptom Assessment Scale |
— | — |
| SECONDARY Effects on the Clinical Global Impression |
— | — |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT01215357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.