NCT01215357

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
7 months until next milestone

Results Posted

Study results publicly available

February 12, 2013

Completed
Last Updated

May 14, 2024

Status Verified

February 1, 2013

Enrollment Period

1.6 years

First QC Date

October 4, 2010

Results QC Date

December 18, 2012

Last Update Submit

April 18, 2024

Conditions

Pathological Gambling

Keywords

Pathological GamblingecopipamDopamine

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Type, Frequency and Severity of Side Effects

    6 weeks

  • Statistically Significant Changes in the Gambling Symptom Assessment Scale

    6 weeks

  • Effects on the Clinical Global Impression

    6 weeks

Study Arms (2)

Ecopipam

EXPERIMENTAL

Ecopipam is a selective antagonist of one the classes of dopamine receptor.

Drug: Ecopipam

Placebo

PLACEBO COMPARATOR

Placebo given first week of the study.

Drug: Ecopipam

Interventions

EcopipamDRUG

50mg tablets

Also known as: PSYRX101, SCH 39166
EcopipamPlacebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Yale University

New Haven, Connecticut, 06519, United States

Location

Carver College of Medicine, University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Minnesota School of Medicine

Minneapolis, Minnesota, 55454, United States

Location

Related Publications (1)

  • 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.

    PMID: 25166480DERIVED

Related Links

MeSH Terms

Conditions

Gambling

Interventions

ecopipam

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental Disorders

Limitations and 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.

Results Point of Contact

Title
Dr. Richard Chipkin
Organization
Psyadon Pharmaceuticals
rchipkin@psyadonrx.com
301-919-2020

Study Officials

  • 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

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2010

First Posted

October 6, 2010

Study Start

October 1, 2010

Primary Completion

May 1, 2012

Study Completion

August 1, 2012

Last Updated

May 14, 2024

Results First Posted

February 12, 2013

Record last verified: 2013-02

Locations

US(4)