A Study of Taurine in Patients With First-episode Psychosis Receiving Antipsychotic Treatment
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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.|
- Cognition (MATRICS Composite score) at 3 months
- Symptomatology at 3 months
- Safety at 3 months
- Tolerability at 3 months
|Study Start Date:||January 2007|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo pill
4 placebo pills daily for 3 months
|Drug: Taurine 4g|
Experimental: Taurine 4g
Taurine 4g daily comprising four 1g pills
|Drug: Taurine 4g|
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 patients.This 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 fashion.Primary 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00420823
|ORYGEN Youth Health|
|Melbourne, Victoria, Australia, 3052|
|RAPPS programme, Southern Health|
|Melbourne, Victoria, Australia, 3168|
|Principal Investigator:||Dr Colin P O'Donnell, MB,MRCPsych||ORYGEN Research Centre , ORYGEN Youth Health,Department of Psychiatry,|