NCT00420823

A Study of Taurine in Patients With First-episode Psychosis Receiving Antipsychotic Treatment

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
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Melbourne Health · Academic / Other
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether Taurine 4g is effective with antipsychotic medication in the treatment of First Episode Psychosis.Taurine 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 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.

Conditions

• Psychotic Disorders

Interventions

Type	Name	Description
DRUG	Taurine 4g

Timeline

• Start date: 2007-01-01
• Primary completion: 2009-12-01
• Completion: 2010-12-01
• First posted: 2007-01-11
• Last updated: 2015-11-20

Locations

2 sites across 1 country: Australia