NCT00420823

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2007

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 11, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

2.9 years

First QC Date

January 8, 2007

Last Update Submit

November 18, 2015

Conditions

Psychotic Disorders

Keywords

First Episode Psychosis

Outcome Measures

Primary Outcomes (2)

  • Cognition (MATRICS Composite score) at 3 months

  • Symptomatology at 3 months

Secondary Outcomes (2)

  • Safety at 3 months

  • Tolerability at 3 months

Study Arms (2)

Placebo pill

PLACEBO COMPARATOR

4 placebo pills daily for 3 months

Drug: Taurine 4g

Taurine 4g

EXPERIMENTAL

Taurine 4g daily comprising four 1g pills

Drug: Taurine 4g

Interventions

Taurine 4gDRUG
Placebo pillTaurine 4g

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ORYGEN Youth Health

Melbourne, Victoria, 3052, Australia

Location

RAPPS programme, Southern Health

Melbourne, Victoria, 3168, Australia

Location

Related Publications (1)

  • 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.

    PMID: 27835719DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Taurine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Alkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Dr Colin P O'Donnell, MB,MRCPsych

    ORYGEN Research Centre , ORYGEN Youth Health,Department of Psychiatry,

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2007

First Posted

January 11, 2007

Study Start

January 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations

AU(2)