Psychotic DisordersPhase 2/3NCT00420823
A Study of Taurine in Patients With First-episode Psychosis Receiving Antipsychotic Treatment
A Phase 2/3 study testing Taurine 4g in people with Psychotic Disorders, run by Melbourne Health at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Psychotic Disorders
- What is being tested?
- Taurine 4g
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 2 sitesAustralia
- Study dates
- Jan 2007to Dec 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
ORYGEN Youth Health
Melbourne, Victoria, 3052
RAPPS programme, Southern Health
Melbourne, Victoria, 3168
About this study
Official 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.
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.
Read the detailed description
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.
- Conditions
- Psychotic Disorders
- Being tested
- Taurine 4g
- Keywords
- First Episode Psychosis
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taurine 4gDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo pill | Placebo comparator | 4 placebo pills daily for 3 months Receives: Drug: Taurine 4g |
| Taurine 4g | Experimental | Taurine 4g daily comprising four 1g pills Receives: Drug: Taurine 4g |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition (MATRICS Composite score) at 3 months
Symptomatology at 3 months
Secondary outcomes (2)
Safety at 3 months
Tolerability at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionDec 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melbourne Health
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Medical Research Institute, Southern Health
- Responsible party
- Sponsor
- Investigators
- Dr Colin P O'Donnell, MB,MRCPsych, Principal investigator, ORYGEN Research Centre , ORYGEN Youth Health,Department of Psychiatry,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00420823
- Sponsor's protocol ID
- MHREC 2006/040
- Other IDs
- SMRI Grant ID Number 06T-811
- Status last verified
- Nov 2015
- First submitted
- 8 Jan 2007
- Last updated
- 20 Nov 2015
- Results posted
- No
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.
PubMed 27835719
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT00420823
- Acronym / sponsor ID
- MHREC 2006/040
- Conditions
- Psychotic Disorders
- Keywords
- First Episode Psychosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Melbourne HealthUniversity, hospital or other
- Collaborators
- Stanley Medical Research Institute, Southern Health
- Study start
- Jan 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo pill | Placebo comparator | Drug: Taurine 4g4 placebo pills daily for 3 months |
| Taurine 4g | Experimental | Drug: Taurine 4gTaurine 4g daily comprising four 1g pills |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taurine 4g | Drug | Placebo pill, Taurine 4g |
Primary outcome
Cognition (MATRICS Composite score) at 3 months
Symptomatology at 3 months
2 secondary outcomes
Safety at 3 months
Tolerability at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Derived from this study: PubMed 27835719O'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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Colin P O'Donnell, MB,MRCPsych principal investigator
ORYGEN Research Centre , ORYGEN Youth Health,Department of Psychiatry,
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Taurine 4g in people with Psychotic Disorders, run by Melbourne Health at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognition (MATRICS Composite score) at 3 months. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00420823, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.