SchizophreniaNCT01139125
An Open Trial of Cysteamine Treatment in Schizophrenia
A study testing (Cystagon) Cysteamine Bitartrate in people with Schizophrenia and Schizoaffective, run by Augusta University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Schizoaffective
- What is being tested?
- (Cystagon) Cysteamine Bitartrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2009to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Georgia Health Sciences University - Dept of Psychiatry
Augusta, Georgia, 30912
Georgia Regents University- Dept of Psychiatry
Augusta, Georgia, 30912
About this study
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.
Read the 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).
- Conditions
- Schizophrenia, Schizoaffective
- Being tested
- (Cystagon) Cysteamine Bitartrate
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(Cystagon) Cysteamine BitartrateDrug
Cysteamine Bitartrate 300mg/day to 2100mg/day over a 4 month period. Number of cycles: until progression or unacceptable toxicity develops.
| Study group | Role | What they receive |
|---|---|---|
| Cystagon, Cysteamine Bitartrate | Experimental | We are examining the safety and efficacy of this medication on the treatment of schizophrenia patients. Receives: Drug: (Cystagon) Cysteamine Bitartrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Efficacy
We are measuring if this medication is appropriate for use in schizophrenia patients.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2010 (estimated)
- Study startSep 2009
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: The study was stopped after 4 years of recruitment difficulties.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Peter F. Buckley, Augusta University
- Investigators
- Peter Buckley, M.D., Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139125
- Sponsor's protocol ID
- HAC09-04-276
- Status last verified
- Nov 2014
- First submitted
- 12 May 2010
- Last updated
- 20 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Trial of Cysteamine Treatment in Schizophrenia
- ClinicalTrials.gov ID
- NCT01139125
- Acronym / sponsor ID
- HAC09-04-276
- Conditions
- Schizophrenia, Schizoaffective
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped after 4 years of recruitment difficulties.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 8 Jun 2010 (estimated)
- Results
- Posted 20 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cystagon, Cysteamine Bitartrate | Experimental | Drug: (Cystagon) Cysteamine BitartrateWe are examining the safety and efficacy of this medication on the treatment of schizophrenia patients. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Diagnosis of schizophrenia or schizoaffective disorder
- 18-60 years of age
- Residual symptoms, as defined by both 1 \& 2:
- No clinically significant change in symptoms for at least one month
- On the same psychotropic medication(s) > 2 weeks
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (Cystagon) Cysteamine BitartrateCysteamine Bitartrate 300mg/day to 2100mg/day over a 4 month period. Number of cycles: until progression or unacceptable toxicity develops. | Drug | Cystagon, Cysteamine Bitartrate |
Primary outcome
Safety and Efficacy
Time frame: 4 months
We are measuring if this medication is appropriate for use in schizophrenia patients.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Buckley, M.D. principal investigator
Augusta University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (Cystagon) Cysteamine Bitartrate in people with Schizophrenia and Schizoaffective, run by Augusta University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Efficacy (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2014.