An Open Trial of Cysteamine Treatment in Schizophrenia
The purpose of this study is to determine the tolerability of the medication cysteamine on schizophrenia patients and to evaluate the effect of the medication on the symptoms of schizophrenia.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Trial of Cysteamine Treatment in Schizophrenia|
- safety and efficacy [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]We are measuring if this medication is appropriate for use in schizophrenia patients.
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||June 2012|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
We are examining the safety and efficacy of this medication on the treatment of schizophrenia patients.
Cysteamine 300mg/day to 2100mg/day over a 4 month period. Number of cycles: until progression or unacceptable toxicity develops.
Other Name: Cystagon, Cysteamine
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139125
|United States, Georgia|
|Georgia Health Sciences University - Dept of Psychiatry|
|Augusta, Georgia, United States, 30912|
|Principal Investigator:||Peter Buckley, M.D.||Georgia Regents University|