An interventional study of (Cystagon) Cysteamine Bitartrate in Schizophrenia and Schizoaffective, sponsored by Augusta University. Terminated at 2 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2014-11-20.
Sponsored by Augusta University · Not applicable, Interventional, and Treatment
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.
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).
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 3 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Augusta University is the lead sponsor of 177 studies on the registry; 24 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
Residual symptoms, as defined by both 1 \& 2:
Exclusion Criteria:
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.
Safety and Efficacy
We are measuring if this medication is appropriate for use in schizophrenia patients.
Time frame: 4 months
| Milestone | Cystagon (Cysteamine Bitartrate) |
|---|---|
| Started | 3 |
| Completed | 2 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
We are measuring if this medication is appropriate for use in schizophrenia patients.
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cystagon | — | 0/3 (0%) | 1/3 (33.3%) |
| Event | Cystagon |
|---|---|
| Jaw Hair FolliculitisSkin and subcutaneous tissue disorders | 1/3 |
| Age, Categorical(Participants) | Cystagon |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 3 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Cystagon |
|---|---|
| Female | 0 |
| Male | 3 |
| Race (NIH/OMB)(Participants) | Cystagon |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Cystagon |
|---|---|
| United States | 3 |
This study is terminated, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Augusta University