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| ID | Type | Description | Link |
|---|---|---|---|
| SMRI Grant ID Number 06T-811 | Other Grant/Funding Number | Stanley Medical Resarch Institute |
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| Name | Class |
|---|---|
| Stanley Medical Research Institute | OTHER |
| Southern Health | OTHER |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo pill | Placebo Comparator | 4 placebo pills daily for 3 months |
|
| Taurine 4g | Experimental | Taurine 4g daily comprising four 1g pills |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taurine 4g | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cognition (MATRICS Composite score) at 3 months | ||
| Symptomatology at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety at 3 months | ||
| Tolerability at 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Colin P O'Donnell, MB,MRCPsych | ORYGEN Research Centre , ORYGEN Youth Health,Department of Psychiatry, | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ORYGEN Youth Health | Melbourne | Victoria | 3052 | Australia | ||
| RAPPS programme, Southern Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27835719 | Derived | 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. |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013654 | Taurine |
| ID | Term |
|---|---|
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
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| Melbourne |
| Victoria |
| 3168 |
| Australia |
| D009930 |
| Organic Chemicals |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |