We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00420823
First Posted: January 11, 2007
Last Update Posted: November 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Stanley Medical Research Institute
Southern Health
Information provided by (Responsible Party):
Melbourne Health
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Drug: Taurine 4g
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Melbourne Health
ClinicalTrials.gov Identifier: NCT00420823     History of Changes
Other Study ID Numbers: MHREC 2006/040
SMRI Grant ID Number 06T-811 ( Other Grant/Funding Number: Stanley Medical Resarch Institute )
First Submitted: January 8, 2007
First Posted: January 11, 2007
Last Update Posted: November 20, 2015
Last Verified: November 2015

Keywords provided by Melbourne Health:
First Episode Psychosis

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs