Schizoaffective, Schizophrenia
Conditions
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).
Interventions
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.
Sponsors
Augusta University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Efficacy | 4 months | We are measuring if this medication is appropriate for use in schizophrenia patients. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cystagon One black male and two white males started the study | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Cystagon |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Safety and Efficacy
We are measuring if this medication is appropriate for use in schizophrenia patients.
Time frame: 4 months