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An Open Trial of Cysteamine Treatment in Schizophrenia

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Dr. Peter F. Buckley, Georgia Health Sciences University
ClinicalTrials.gov Identifier:
NCT01139125
First received: May 12, 2010
Last updated: April 19, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
Schizophrenia
Schizoaffective
 Drug: Cysteamine

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Georgia Regents University:

Primary Outcome Measures:
  • 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.


Enrollment: 4
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)
Arms Assigned Interventions
Experimental: Cystagon
We are examining the safety and efficacy of this medication on the treatment of schizophrenia patients.
 Drug: Cysteamine
Cysteamine 300mg/day to 2100mg/day over a 4 month period. Number of cycles: until progression or unacceptable toxicity develops.
Other Name: Cystagon, Cysteamine

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).

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139125

Locations
United States, Georgia
Georgia Health Sciences University - Dept of Psychiatry
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Georgia Regents University
Investigators
Principal Investigator: Peter Buckley, M.D. Georgia Regents University
  More Information

No publications provided

Responsible Party: Dr. Peter F. Buckley, Dean of the Medical College at Georgia Health Sciences University, Georgia Health Sciences University
ClinicalTrials.gov Identifier: NCT01139125     History of Changes
Other Study ID Numbers: HAC09-04-276
Study First Received: May 12, 2010
Last Updated: April 19, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Cysteamine
 Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013