NCT01139125

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2010

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 8, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

November 20, 2014

Completed
Last Updated

November 20, 2014

Status Verified

November 1, 2014

Enrollment Period

2.8 years

First QC Date

May 12, 2010

Results QC Date

March 27, 2014

Last Update Submit

November 19, 2014

Conditions

SchizophreniaSchizoaffective

Outcome Measures

Primary Outcomes (1)

  • Safety and Efficacy

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

    4 months

Study Arms (1)

Cystagon, Cysteamine Bitartrate

EXPERIMENTAL

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

Drug: (Cystagon) Cysteamine Bitartrate

Interventions

(Cystagon) Cysteamine BitartrateDRUG

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

Cystagon, Cysteamine Bitartrate

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of schizophrenia or schizoaffective disorder
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Georgia Health Sciences University - Dept of Psychiatry

Augusta, Georgia, 30912, United States

Location

Georgia Regents University- Dept of Psychiatry

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Cysteamine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MercaptoethylaminesEthylaminesAminesOrganic ChemicalsSulfhydryl CompoundsSulfur Compounds

Limitations and Caveats

Recruitment challenges for this study are the number of pills that the subjects are required to take during treatment and the reported foul body odor that the subjects complianed of and was also noted by the Investigator and research staff.

Results Point of Contact

Title
Peter F. Buckley, MD
Organization
Georgia Regents University
PBuckley@gru.edu
706-721-2231

Study Officials

  • Peter Buckley, M.D.

    Augusta University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean of the Medical College at Georgia Health Sciences University

Study Record Dates

First Submitted

May 12, 2010

First Posted

June 8, 2010

Study Start

September 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

November 20, 2014

Results First Posted

November 20, 2014

Record last verified: 2014-11

Locations

US(2)