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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
A Study of Taurine in Patients With First-episode Psychosis Receiving Antipsychotic Treatment
Scientific 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.
Secondary ID [1] 0 0
SMRI Grant ID Number 06T-811
Secondary ID [2] 0 0
MHREC 2006/040
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychotic Disorders 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Psychosis and personality disorders

Study type
Description of intervention(s) / exposure
Treatment: Drugs - Taurine 4g

Placebo Comparator: Placebo pill - 4 placebo pills daily for 3 months

Experimental: Taurine 4g - Taurine 4g daily comprising four 1g pills

Treatment: Drugs: Taurine 4g

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Cognition (MATRICS Composite score) at 3 months
Timepoint [1] 0 0
Primary outcome [2] 0 0
Symptomatology at 3 months
Timepoint [2] 0 0
Secondary outcome [1] 0 0
Safety at 3 months
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Tolerability at 3 months
Timepoint [2] 0 0

Key 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.
Minimum age
18 Years
Maximum age
25 Years
Both males and females
Can healthy volunteers participate?
Key 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

- 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
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase 2/Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
ORYGEN Youth Health - Melbourne
Recruitment hospital [2] 0 0
RAPPS programme, Southern Health - Melbourne
Recruitment postcode(s) [1] 0 0
3052 - Melbourne
Recruitment postcode(s) [2] 0 0
3168 - Melbourne

Funding & Sponsors
Primary sponsor type
Melbourne Health
Other collaborator category [1] 0 0
Name [1] 0 0
Stanley Medical Research Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Name [2] 0 0
Southern Health
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Dr Colin P O'Donnell, MB,MRCPsych
Address 0 0
ORYGEN Research Centre , ORYGEN Youth Health,Department of Psychiatry,
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications