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

Psychotic Disorders Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00420823
• Other study ID #: MHREC 2006/040
• Secondary ID: SMRI Grant ID Nu
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 8, 2007
• Last updated: November 18, 2015
• Start date: January 2007
• Est. completion date: December 2010

Study information

• Verified date: November 2015
• Source: Melbourne Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

• Male and females

• Between 18 and 25 years of age

• First Episode Psychosis

• Attending ORYGEN Youth Health, a geographical based catchment area service for young people aged between 15 and 25.

Exclusion Criteria:

• Organic disorders presenting with a psychotic syndrome (e.g. brain tumour, temporal lobe epilepsy, HIV encephalopathy)

• Mental retardation (unable and/or unlikely to give appropriate information of symptomatology or side-effects (IQ approximately lower than 80)

• History of clinically significant physical illness (e.g. terminal cancer, renal dialysis)

• History of brain surgery

• History of brain infarction

• Pregnant or lactating women or women of childbearing potential not using an acceptable method of contraception.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

Intervention

Drug:
• Taurine 4g

Locations

Country	Name	City	State
Australia	ORYGEN Youth Health	Melbourne	Victoria
Australia	RAPPS programme, Southern Health	Melbourne	Victoria

Sponsors (3)

Lead Sponsor	Collaborator
Melbourne Health	Southern Health, Stanley Medical Research Institute

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognition (MATRICS Composite score) at 3 months
Primary	Symptomatology at 3 months
Secondary	Safety at 3 months
Secondary	Tolerability at 3 months