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

Study Description
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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 schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Drug: (Cystagon) Cysteamine Bitartrate Not Applicable

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 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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Trial of Cysteamine Treatment in Schizophrenia
Study Start Date : September 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cystagon, Cysteamine Bitartrate
We are examining the safety and efficacy of this medication on the treatment of schizophrenia patients.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Safety and Efficacy [ Time Frame: 4 months ]
    We are measuring if this medication is appropriate for use in schizophrenia patients.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01139125


Locations
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United States, Georgia
Georgia Health Sciences University - Dept of Psychiatry
Augusta, Georgia, United States, 30912
Georgia Regents University- Dept of Psychiatry
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Augusta University
Investigators
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Principal Investigator: Peter Buckley, M.D. Augusta University
More Information
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Responsible Party: Dr. Peter F. Buckley, Dean of the Medical College at Georgia Health Sciences University, Augusta University
ClinicalTrials.gov Identifier: NCT01139125    
Other Study ID Numbers: HAC09-04-276
First Posted: June 8, 2010    Key Record Dates
Results First Posted: November 20, 2014
Last Update Posted: November 20, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
 Cysteamine
Cystine Depleting Agents
Molecular Mechanisms of Pharmacological Action