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.

Study Overview

• Status: Terminated
• Conditions: Schizophrenia; Schizoaffective
• Intervention / Treatment: Drug: (Cystagon) Cysteamine Bitartrate

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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Georgia Health Sciences University - Dept of Psychiatry
    • Augusta, Georgia, United States, 30912
      • Georgia Regents University- Dept of Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Augusta University
• Investigators: Principal Investigator: Peter Buckley, M.D., Augusta University

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: May 12, 2010
• First Submitted That Met QC Criteria: June 4, 2010
• First Posted (Estimate): June 8, 2010

Study Record Updates

• Last Update Posted (Estimate): November 20, 2014
• Last Update Submitted That Met QC Criteria: November 19, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Molecular Mechanisms of Pharmacological Action; Cystine Depleting Agents; Cysteamine
• Other Study ID Numbers: HAC09-04-276