Clinical Study to Determine if Ecopipam Can Reduce Urges to Gamble

• Sponsor: Psyadon Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01215357
• Collaborator: (none)
• Enrollment: 34
• Locations: 4
• Arm: 1
• Duration (Months): 22
• Patients Per Site: 8.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pathological Gambling	Drug: Ecopipam	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Ecopipam Treatment of Pathological Gambling
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ecopipam Ecopipam is a selective antagonist of one the classes of dopamine receptor.	Drug: Ecopipam; 50mg tablets; Other Names: PSYRX101 SCH 39166

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Type, Frequency and Severity of Side Effects [6 weeks]

   All side effects of the drug will be monitored and recorded

2. Statistically Significant Changes in the Gambling Symptom Assessment Scale [6 weeks]

   It is expected that there will be decreases in this scale

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Los Angeles	Los Angeles	California	United States	90095
2	Yale University	New Haven	Connecticut	United States	06519
3	Carver College of Medicine, University of Iowa	Iowa City	Iowa	United States	52242
4	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Psyadon Pharmaceutical's Website

Publications

None provided.

• Responsible Party: Psyadon Pharma
• ClinicalTrials.gov Identifier: NCT01215357
• Other Study ID Numbers: PSY201; NCT01198951
• First Posted: Oct 6, 2010
• Last Update Posted: Mar 8, 2013
• Last Verified: Feb 1, 2013

• Keywords provided by Psyadon Pharma: Pathological Gambling; ecopipam; Dopamine
• Additional relevant MeSH terms: Gambling; Ecopipam

Study Results

Participant Flow

Recruitment Details	Recruitment started Sept 2010 and finished June 2011
Pre-assignment Detail	See exclusion criteria

Arm/Group Title	Ecopipam (50 or 100 mg, as Needed)
Arm/Group Description	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.
Period Title: Overall Study
STARTED	34
COMPLETED	22
NOT COMPLETED	12

Baseline Characteristics

Arm/Group Title	Ecopipam 50 or 100 mg, as Needed
Arm/Group Description	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.
Overall Participants	34
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	34 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.8 (13.35)
Sex: Female, Male (Count of Participants)
Female	15 44.1%
Male	19 55.9%
Region of Enrollment (participants) [Number]
United States	34 100%

Outcome Measures

1. Primary Outcome

Title	Statistically Significant (p<0.05) Decrease From Baseline in Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling
Description	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

Outcome Measure Data

Analysis Population Description

Patients completing all visits

Arm/Group Title	Ecopipam 50 mg or 100 mg as Needed
Arm/Group Description	Patients were instructed to take one 50 mg tablet of ecopipam when they had an urge to gamble. If this was effective, they should not take any more drug. If it was not effective, they were permitted to take a second 50 mg tablet of ecopipam. If this was effective, they should not take any more drug. If this was not effective, they were not permitted to take any additional ecopipam.
Measure Participants	28
Mean (Standard Deviation) [YBOCS score]	13.9 (8.79)

2. Secondary Outcome

Title	Type, Frequency and Severity of Side Effects
Description	All side effects of the drug will be monitored and recorded
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Statistically Significant Changes in the Gambling Symptom Assessment Scale
Description	It is expected that there will be decreases in this scale
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Effects on the Clinical Global Impression
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	8 weeks
Arm/Group Title	Ecopipam 50 or 100 mg, as Needed
Arm/Group Description	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.
All Cause Mortality
	Ecopipam 50 or 100 mg, as Needed
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Ecopipam 50 or 100 mg, as Needed
	Affected / at Risk (%)	# Events
Total	0/34 (0%)
Other (Not Including Serious) Adverse Events
	Ecopipam 50 or 100 mg, as Needed
	Affected / at Risk (%)	# Events
Total	13/34 (38.2%)
Eye disorders
Rhinorrhea	2/34 (5.9%)	2
Gastrointestinal disorders
Constipation	2/34 (5.9%)	2
Vomiting	2/34 (5.9%)	2
Nervous system disorders
Sedation	4/34 (11.8%)	4
Anxiety	3/34 (8.8%)	3

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.