Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

An Open Trial of Cysteamine Treatment in Schizophrenia

This study has been terminated.
(The study was stopped after 4 years of recruitment difficulties.)
Sponsor:
Information provided by (Responsible Party):
Dr. Peter F. Buckley, Georgia Regents University
ClinicalTrials.gov Identifier:
NCT01139125
First received: May 12, 2010
Last updated: November 19, 2014
Last verified: November 2014
Results First Received: March 27, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Schizophrenia
Schizoaffective
Intervention: Drug: (Cystagon) Cysteamine Bitartrate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cystagon (Cysteamine Bitartrate) Subjects were expected to take cystagon (cysteamine bitarate)14 capsules per day (4 at 7:00 am, 3 at 12:00 pm, 4 at 5:00 pm and 3 at 10:00pm) for 16 weeks.

Participant Flow:   Overall Study
    Cystagon (Cysteamine Bitartrate)  
STARTED     3  
COMPLETED     2  
NOT COMPLETED     1  
Withdrawal by Subject                 1  



  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
Cystagon One black male and two white males started the study

Baseline Measures
    Cystagon  
Number of Participants  
[units: participants]
  3  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     3  
>=65 years     0  
Gender  
[units: participants]
 
Female     0  
Male     3  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     1  
White     2  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     3  



  Outcome Measures

1.  Primary:   Safety and Efficacy   [ Time Frame: 4 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Recruitment challenges for this study are the number of pills that the subjects are required to take during treatment and the reported foul body odor that the subjects complianed of and was also noted by the Investigator and research staff.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Peter F. Buckley, MD
Organization: Georgia Regents University
phone: 706-721-2231
e-mail: PBuckley@gru.edu


No publications provided


Responsible Party: Dr. Peter F. Buckley, Georgia Regents University
ClinicalTrials.gov Identifier: NCT01139125     History of Changes
Other Study ID Numbers: HAC09-04-276
Study First Received: May 12, 2010
Results First Received: March 27, 2014
Last Updated: November 19, 2014
Health Authority: United States: Institutional Review Board