Status:
TERMINATED
An Open Trial of Cysteamine Treatment in Schizophrenia
Lead Sponsor:
Augusta University
Conditions:
Schizophrenia
Schizoaffective
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The purpose of this study is to determine the tolerability of the medication cysteamine bitartrate on schizophrenia patients and to evaluate the effect of the medication on the symptoms of schizophren...
Detailed Description
Despite the availability of numerous antipsychotics, the treatment of schizophrenia is very unsatisfactory. Many patients have persistent positive psychotic symptoms or negative symptoms despite treat...
Eligibility Criteria
Inclusion
- Diagnosis of schizophrenia or schizoaffective disorder
- 18-60 years of age
- Residual symptoms, as defined by both 1 \& 2:
- At least one PANSS positive symptom item score \> 4, or at least two items with a score \> 3
- At least one PANSS negative symptom item score \> 4, or at two items with a score \> 3
- No clinically significant change in symptoms for at least one month
- On the same psychotropic medication(s) \> 2 weeks
- Taking a second-generation antipsychotic (olanzapine, risperidone, quetiapine, ziprasidone, aripiprazole, or clozapine)
- Provision of written informed consent
Exclusion
- Meets criteria for current major depressive disorder
- Abnormal hepatic function (AST or ALT \> 2.5 X the upper limit of normal, or bilirubin \> 1.5 X the upper limit of normal)
- Abnormal renal function (BUN or creatinine \> 1.5 X the upper limit of normal)
- Presence of any unstable or untreated medical disorder
- Any history of seizure disorder, HIV, or diagnosis of AIDS
- Any abnormal lab test result that is judged to be clinically significant by the investigators
- Pregnancy, breast feeding, or female and of child-bearing potential who is not using any contraceptive method
- Present danger to self or others
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01139125
Start Date
September 1 2009
End Date
June 1 2012
Last Update
November 20 2014
Active Locations (2)
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1
Georgia Health Sciences University - Dept of Psychiatry
Augusta, Georgia, United States, 30912
2
Georgia Regents University- Dept of Psychiatry
Augusta, Georgia, United States, 30912