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
  Purpose

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.


Condition Intervention Phase
Psychotic Disorders
Drug: Taurine 4g
Phase 2
Phase 3

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Melbourne Health:

Primary Outcome Measures:
  • Cognition (MATRICS Composite score) at 3 months
  • Symptomatology at 3 months

Secondary Outcome Measures:
  • Safety at 3 months
  • Tolerability at 3 months

Enrollment: 121
Study Start Date: January 2007
Study Completion Date: December 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo pill
4 placebo pills daily for 3 months
Experimental: Taurine 4g
Taurine 4g daily comprising four 1g pills
Drug: Taurine 4g

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.

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00420823

Locations
Australia, Victoria
ORYGEN Youth Health
Melbourne, Victoria, Australia, 3052
RAPPS programme, Southern Health
Melbourne, Victoria, Australia, 3168
Sponsors and Collaborators
Melbourne Health
Stanley Medical Research Institute
Southern Health
Investigators
Principal Investigator: Dr Colin P O'Donnell, MB,MRCPsych ORYGEN Research Centre , ORYGEN Youth Health,Department of Psychiatry,
  More Information

No publications provided

Responsible Party: Melbourne Health
ClinicalTrials.gov Identifier: NCT00420823     History of Changes
Other Study ID Numbers: MHREC 2006/040, SMRI Grant ID Number 06T-811
Study First Received: January 8, 2007
Last Updated: May 28, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Melbourne Health:
First Episode Psychosis

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 15, 2014