A Study of Taurine in Patients With First-episode Psychosis Receiving Antipsychotic Treatment
NCT ID: NCT00420823
Last Updated: 2015-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
121 participants
INTERVENTIONAL
2007-01-31
2010-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo pill
4 placebo pills daily for 3 months
Taurine 4g
Taurine 4g
Taurine 4g daily comprising four 1g pills
Taurine 4g
Interventions
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Taurine 4g
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
25 Years
ALL
No
Sponsors
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Stanley Medical Research Institute
OTHER
Southern Health
OTHER
Melbourne Health
OTHER
Responsible Party
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Principal Investigators
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Dr Colin P O'Donnell, MB,MRCPsych
Role: PRINCIPAL_INVESTIGATOR
ORYGEN Research Centre , ORYGEN Youth Health,Department of Psychiatry,
Locations
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ORYGEN Youth Health
Melbourne, Victoria, Australia
RAPPS programme, Southern Health
Melbourne, Victoria, Australia
Countries
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References
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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.
Other Identifiers
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SMRI Grant ID Number 06T-811
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
MHREC 2006/040
Identifier Type: -
Identifier Source: org_study_id