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Trial record 15 of 32 for:    CYSTEAMINE

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.
 
ClinicalTrials.gov 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
Sponsor:
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
Schizoaffective
Intervention Drug: (Cystagon) Cysteamine Bitartrate
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cystagon (Cysteamine Bitartrate)
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 3
Completed 2
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Cystagon
Hide Arm/Group Description One black male and two white males started the study
Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
0
   0.0%
Male
3
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
  33.3%
White
2
  66.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title Safety and Efficacy
Hide Description We are measuring if this medication is appropriate for use in schizophrenia patients.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cystagon
Hide Arm/Group Description:
Subjects are required to take 14 capsules per day for 16 weeks
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cystagon
Hide Arm/Group Description Subjects taking 14 capsules per day for 16 weeks
All-Cause Mortality
Cystagon
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cystagon
Affected / at Risk (%) # Events
Total   0/3 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cystagon
Affected / at Risk (%) # Events
Total   1/3 (33.33%)    
Skin and subcutaneous tissue disorders   
Jaw Hair Folliculitis  1/3 (33.33%)  1
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.
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
Layout table for Results Point of Contact information
Name/Title: Peter F. Buckley, MD
Organization: Georgia Regents University
Phone: 706-721-2231
EMail: PBuckley@gru.edu
Layout table for additonal information
Responsible Party: Dr. Peter F. Buckley, Augusta University
ClinicalTrials.gov 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