An Open Trial of Cysteamine Treatment in Schizophrenia

Schizophrenia Clinical Trial

Official title:

An Open Trial of Cysteamine Treatment in Schizophrenia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01139125
• Other study ID #: HAC09-04-276
• Status: Terminated
• Phase: N/A
• First received: May 12, 2010
• Last updated: November 19, 2014
• Start date: September 2009
• Est. completion date: June 2012

Study information

• Verified date: November 2014
• Source: Georgia Regents University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizoaffective
• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
United States	Georgia Health Sciences University - Dept of Psychiatry	Augusta	Georgia
United States	Georgia Regents University- Dept of Psychiatry	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Georgia Regents University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Efficacy	We are measuring if this medication is appropriate for use in schizophrenia patients.	4 months	Yes