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Clinical Study to Determine if Ecopipam Can Reduce Urges to Gamble

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01215357
First Posted: October 6, 2010
Last Update Posted: March 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Psyadon Pharma
Results First Submitted: December 18, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Pathological Gambling
Intervention: Drug: Ecopipam

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment started Sept 2010 and finished June 2011

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
See exclusion criteria

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Ecopipam (50 or 100 mg, as Needed)
STARTED   34 
COMPLETED   22 
NOT COMPLETED   12 
Withdrawal by Subject                3 
Protocol Violation                9 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Baseline Measures
   Ecopipam 50 or 100 mg, as Needed 
Overall Participants Analyzed 
[Units: Participants]
 34 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   34 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.8  (13.35) 
Gender 
[Units: Participants]
 
Female   15 
Male   19 
Region of Enrollment 
[Units: Participants]
 
United States   34 


  Outcome Measures

1.  Primary:   Statistically Significant (p<0.05) Decrease From Baseline in Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling   [ Time Frame: Baseline and 6 weeks ]

2.  Secondary:   Type, Frequency and Severity of Side Effects   [ Time Frame: 6 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Statistically Significant Changes in the Gambling Symptom Assessment Scale   [ Time Frame: 6 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Effects on the Clinical Global Impression   [ Time Frame: 6 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Richard Chipkin
Organization: Psyadon Pharmaceuticals
phone: 301-919-2020
e-mail: rchipkin@psyadonrx.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Psyadon Pharma
ClinicalTrials.gov Identifier: NCT01215357     History of Changes
Obsolete Identifiers: NCT01198951
Other Study ID Numbers: PSY201
First Submitted: October 4, 2010
First Posted: October 6, 2010
Results First Submitted: December 18, 2012
Results First Posted: February 12, 2013
Last Update Posted: March 8, 2013