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. 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
Information provided by (Responsible Party):
Dr. Peter F. Buckley, Augusta University

May 12, 2010
June 8, 2010
March 27, 2014
November 20, 2014
November 20, 2014
September 2009
June 2012   (Final data collection date for primary outcome measure)
Safety and Efficacy [ Time Frame: 4 months ]
We are measuring if this medication is appropriate for use in schizophrenia patients.
Same as current
Complete list of historical versions of study NCT01139125 on Archive Site
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An Open Trial of Cysteamine Treatment in Schizophrenia
An Open Trial of Cysteamine Treatment in Schizophrenia
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.

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).

Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective
Drug: (Cystagon) Cysteamine Bitartrate
Cysteamine Bitartrate 300mg/day to 2100mg/day over a 4 month period. Number of cycles: until progression or unacceptable toxicity develops.
Experimental: Cystagon, Cysteamine Bitartrate
We are examining the safety and efficacy of this medication on the treatment of schizophrenia patients.
Intervention: Drug: (Cystagon) Cysteamine Bitartrate
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2012
June 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Dr. Peter F. Buckley, Augusta University
Augusta University
Not Provided
Principal Investigator: Peter Buckley, M.D. Augusta University
Augusta University
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP