An Open Trial of Cysteamine Treatment in Schizophrenia

Study Overview
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Brief Summary
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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.

Detailed Description
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Despite the availability of numerous antipsychotics, the treatment of schizophrenia is very unsatisfactory. Many patients have persistent positive psychotic symptoms or negative symptoms despite treatment, and any improvement in cognitive function is small. New approaches to the pharmacotherapy of schizophrenia that are not based primarily on dopaminergic blockade are needed. The rationale for a trial of cysteamine comes from the evidence that cysteamine increases brain concentrations of brain-derived neurotrophic factor. We will conduct an open-label study of tolerability and efficacy of cysteamine as an adjunct to second-generation antipsychotics in schizophrenia and schizoaffective subjects with partially responsive symptoms. Our objectives are to determine the safety and tolerability of cysteamine administered as an adjunct to second-generation antipsychotic drugs in adult outpatients with partially-responsive schizophrenia. Additionally, we are evaluating the effect of cysteamine on the positive and negative symptoms of schizophrenia as measured by changes in the Positive and Negative Symptom Scale (PANSS), and on cognitive impairment as measured by the Brief Assessment of Cognition in Schizophrenia (BACS).

Official Title
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An Open Trial of Cysteamine Treatment in Schizophrenia

Conditions
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Schizophrenia, Schizoaffective

Intervention / Treatment
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* Drug: (Cystagon) Cysteamine Bitartrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cystagon, Cysteamine Bitartrate<br>We are examining the safety and efficacy of this medication on the treatment of schizophrenia patients. | Drug: (Cystagon) Cysteamine Bitartrate<br>* Cysteamine Bitartrate 300mg/day to 2100mg/day over a 4 month period. Number of cycles: until progression or unacceptable toxicity develops.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Efficacy | We are measuring if this medication is appropriate for use in schizophrenia patients. | 4 months |