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

This study has been completed.

Sponsor:

Collaborators:

Stanley Medical Research Institute

Southern Health

Information provided by (Responsible Party):

Melbourne Health

ClinicalTrials.gov Identifier:

NCT00420823

First received: January 8, 2007

Last updated: May 28, 2013

Last verified: January 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

January 8, 2007

Last Updated Date

May 28, 2013

Start Date ^ICMJE

January 2007

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Cognition (MATRICS Composite score) at 3 months
Symptomatology at 3 months

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00420823 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety at 3 months
Tolerability at 3 months

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Psychotic Disorders

Intervention ^ICMJE

Drug: Taurine 4g

Study Arm (s)

Placebo Comparator: Placebo pill
4 placebo pills daily for 3 months
Experimental: Taurine 4g
Taurine 4g daily comprising four 1g pills

Intervention: Drug: Taurine 4g

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

121

Completion Date

December 2010

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 25 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia

Administrative Information

NCT Number ^ICMJE

NCT00420823

Other Study ID Numbers ^ICMJE

MHREC 2006/040, SMRI Grant ID Number 06T-811

Has Data Monitoring Committee

Not Provided

Responsible Party

Melbourne Health

Study Sponsor ^ICMJE

Melbourne Health

Collaborators ^ICMJE

Stanley Medical Research Institute
Southern Health

Investigators ^ICMJE

Principal Investigator:

Dr Colin P O'Donnell, MB,MRCPsych

ORYGEN Research Centre , ORYGEN Youth Health,Department of Psychiatry,

Information Provided By

Melbourne Health

Verification Date

January 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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