An Open Trial of Cysteamine Treatment in Schizophrenia

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. Identifier: NCT01139125
Recruitment Status : Terminated (The study was stopped after 4 years of recruitment difficulties.)
First Posted : June 8, 2010
Results First Posted : November 20, 2014
Last Update Posted : November 20, 2014
Information provided by (Responsible Party):
Dr. Peter F. Buckley, Augusta University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Schizophrenia
Intervention: Drug: (Cystagon) Cysteamine Bitartrate

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
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)
Withdrawal by Subject                1 

  Baseline Characteristics

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.
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Reporting Groups
Cystagon One black male and two white males started the study

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   3 
>=65 years   0 
[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

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

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

Responsible Party: Dr. Peter F. Buckley, Augusta University Identifier: NCT01139125     History of Changes
Other Study ID Numbers: HAC09-04-276
First Submitted: May 12, 2010
First Posted: June 8, 2010
Results First Submitted: March 27, 2014
Results First Posted: November 20, 2014
Last Update Posted: November 20, 2014