Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00420823
Status:
COMPLETED
Last Update Posted:
2015-11-20
First Post:
2007-01-08
Brief Title:
A Study of Taurine in Patients With First-episode Psychosis Receiving Antipsychotic Treatment
Sponsor:
Melbourne Health
Organization:
Melbourne Health
Study Overview
Official Title:
A 12-week Parallel Double-blind Randomised Placebo-controlled Adjunctive Study of Taurine 4 Grams in 128 Patients With First-episode Psychosis Receiving Antipsychotic Treatment
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether Taurine 4g is effective with antipsychotic medication in the treatment of First Episode PsychosisTaurine may have an effect on cognition and symptoms We are examining changes in symptoms and cognition over a 3 month period
Detailed Description:
The core rationale of this study will be to prospectively investigate whether Taurine will improve and or protect cognitive functioning and improve symptomatology in a cohort of 128 first episode psychosis patientsThis is a randomized double blind placebo controlled add on standard therapy trial of Taurine 4g in young patients between 18-25 presenting to ORYGEN Youth Health a sub program of Melbourne Health and RAPPS a subprogram of Southern Health with a first psychotic episode Taurine will be compared with placebo added to standard treatment for a period of 12 weeks in a double blind fashionPrimary outcome measures will be psychopathology and cognition MATRICS
Secondary outcome measures will be tolerability and safety measures drop-out rates general side effect scale UKU
Patients who give informed consent will be randomised to receive treatment with Taurine 4g daily or placebo for 12 weeks
Patients will be randomised by a dynamic randomisation method called minimization which allocates patients to treatment group by checking the allocation of similar patients already randomised and allocating the next treatment group live to best balance the treatment groups across all stratification variables The minimization will be carried out by the NHMRC clinical trials centre in Sydney and the patient will be randomized to either placebo or vitamin
Each patient will collect their tablets from the clinical trials pharmacy The Clinical Trials Pharmacy will dispense either vitamin or placebo All study personnel and participants will be blinded to treatment assignment for the duration of the study
Secondary outcome measures will be tolerability and safety measures drop-out rates general side effect scale UKU
Patients who give informed consent will be randomised to receive treatment with Taurine 4g daily or placebo for 12 weeks
Patients will be randomised by a dynamic randomisation method called minimization which allocates patients to treatment group by checking the allocation of similar patients already randomised and allocating the next treatment group live to best balance the treatment groups across all stratification variables The minimization will be carried out by the NHMRC clinical trials centre in Sydney and the patient will be randomized to either placebo or vitamin
Each patient will collect their tablets from the clinical trials pharmacy The Clinical Trials Pharmacy will dispense either vitamin or placebo All study personnel and participants will be blinded to treatment assignment for the duration of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SMRI Grant ID Number 06T-811 | OTHER_GRANT | Stanley Medical Resarch Institute | None |