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An Open Trial of Cysteamine Treatment in Schizophrenia

Primary Purpose

Schizophrenia, Schizoaffective

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

(Cystagon) Cysteamine Bitartrate

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Georgia Health Sciences University - Dept of Psychiatry
Georgia Regents University- Dept of Psychiatry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cystagon, Cysteamine Bitartrate

Arm Description

We are examining the safety and efficacy of this medication on the treatment of schizophrenia patients.

Outcomes

Primary Outcome Measures

Safety and Efficacy

We are measuring if this medication is appropriate for use in schizophrenia patients.

Secondary Outcome Measures

Full Information

NCT ID

NCT01139125

First Posted

May 12, 2010

Last Updated

November 19, 2014

Sponsor

Augusta University

1. Study Identification

Unique Protocol Identification Number

NCT01139125

Brief Title

An Open Trial of Cysteamine Treatment in Schizophrenia

Official Title

An Open Trial of Cysteamine Treatment in Schizophrenia

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Terminated

Why Stopped

The study was stopped after 4 years of recruitment difficulties.

Study Start Date

September 2009 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Augusta University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia, Schizoaffective

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cystagon, Cysteamine Bitartrate

Arm Type

Experimental

Arm Description

We are examining the safety and efficacy of this medication on the treatment of schizophrenia patients.

Intervention Type

Drug

Intervention Name(s)

(Cystagon) Cysteamine Bitartrate

Intervention Description

Cysteamine Bitartrate 300mg/day to 2100mg/day over a 4 month period. Number of cycles: until progression or unacceptable toxicity develops.

Primary Outcome Measure Information:

Title

Safety and Efficacy

Description

We are measuring if this medication is appropriate for use in schizophrenia patients.

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of schizophrenia or schizoaffective disorder 18-60 years of age Residual symptoms, as defined by both 1 & 2: At least one PANSS positive symptom item score > 4, or at least two items with a score > 3 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Buckley, M.D.

Organizational Affiliation

Augusta University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Georgia Health Sciences University - Dept of Psychiatry

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

Facility Name

Georgia Regents University- Dept of Psychiatry

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

12. IPD Sharing Statement

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An Open Trial of Cysteamine Treatment in Schizophrenia

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