An Open Trial of Cysteamine Treatment in Schizophrenia

• Status: Terminated
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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 schizophrenia.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Augusta University
• Treatments: Cysteamine

Criteria

Inclusion Criteria:

• Diagnosis of schizophrenia or schizoaffective disorder

• 18-60 years of age

• Residual symptoms, as defined by both 1 & 2:

1. At least one PANSS positive symptom item score > 4, or at least two items with a score > 3

2. 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 Criteria:

• 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