Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00420823




Registration number
NCT00420823
Ethics application status
Date submitted
8/01/2007
Date registered
11/01/2007
Date last updated
20/11/2015

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Placebo comparator: Placebo pill - 4 placebo pills daily for 3 months

Experimental: Taurine 4g - Taurine 4g daily comprising four 1g pills
Comparator / control treatment
Control group

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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 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
Purpose of the study
Treatment
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
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2010
Sample size
Target
Accrual to date
Final
121
Recruitment in Australia
Recruitment state(s)
VIC
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
Other
Name
Melbourne Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Stanley Medical Research Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Southern Health
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00420823
Trial related presentations / publications
O'Donnell CP, Allott KA, Murphy BP, Yuen HP, Proffitt TM, Papas A, Moral J, Pham T, O'Regan MK, Phassouliotis C, Simpson R, McGorry PD. Adjunctive Taurine in First-Episode Psychosis: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study. J Clin Psychiatry. 2016 Dec;77(12):e1610-e1617. doi: 10.4088/JCP.15m10185.
Public notes

Contacts
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00420823