Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000184279
Ethics application status
Not yet submitted
Date submitted
31/10/2008
Date registered
17/04/2009
Date last updated
17/04/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tailoring Adjunct Glycine Therapy in Schizophrenia
Scientific title
Tailoring Adjunct Glycine Therapy to Improve Cognitive Function and Clinical Symptoms in Schizophrenia
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 3828 0
Condition category
Condition code
Mental Health 4015 4015 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Glycine, 0.8g/kg oral administration per day for 6 weeks, in conjunction with patient's current antipsychotic medication
Intervention code [1] 3550 0
Treatment: Drugs
Comparator / control treatment
Placebo (0.8g/kg glucose) oral administration per day for 6 weeks, in conjunction with patient's current antipsychotic medication
Control group
Placebo

Outcomes
Primary outcome [1] 4914 0
Cognition as measured by the CogState Schizophrenia Cognitive Test Battery
Timepoint [1] 4914 0
at baseline, 3 weeks, and 6 weeks after treatment commencement
Primary outcome [2] 4915 0
Mismatch Negativity (MMN) amplitude as measured by electroencephalography (EEG)
Timepoint [2] 4915 0
at baseline and 6 weeks after treatment commencement
Primary outcome [3] 4916 0
Positive and Negative Symptom Scale (PANSS) score
Timepoint [3] 4916 0
at baseline, 3 weeks, and 6 weeks after treatment commencement
Secondary outcome [1] 8298 0
Calgary Depression Rating Scale (CDRS) score
Timepoint [1] 8298 0
at baseline, 3 weeks, and 6 weeks after treatment commencement
Secondary outcome [2] 8299 0
Work and Social Adjustment Scale (WSAS) score
Timepoint [2] 8299 0
at baseline, 3 weeks, and 6 weeks after treatment commencement

Eligibility
Key inclusion criteria
* Currently meet Diagnostic & Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria for a diagnosis of chronic schizophrenia
* Aged 18-45 years
* Clinically stable for 3 months
* Currently on stable atypical antipsychotic (other than Clozapine) therapy, where type of medication has been unaltered for 2 months and medication dose has been unaltered for 1 month prior to start of study
* Capacity to provide consent
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Comorbid diagnosis of other Axis 1 conditions including alcohol or substance dependence
* Currently on Clozapine (patients on Clozapine will not be used due its effects on the NDMA receptor)
* History of head injury
* History of hearing difficulties (patient report)
* Pregnant or breastfeeding
* Use of prescription or non-prescription drugs (other than antipsychotic drugs for schizophrenia patients), including vitamins, herbal and dietary supplements within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first study visit, unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise subject safety.

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)
The patient will be randomly allocated to either the glycine or placebo treatment by a member of the research team who is 'offsite' and not involved in the recruitment or testing of study participants. Treatment will be counterbalanced amongst patients and both the patient and investigator will be blind to the assigned treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1203 0
3000

Funding & Sponsors
Funding source category [1] 4012 0
Government body
Name [1] 4012 0
National Health and Medical Research Council (NHMRC)
Country [1] 4012 0
Australia
Primary sponsor type
Hospital
Name
Alfred Hospital
Address
The Alfred Hospital
Commercial Rd
Melbourne
VIC 3004
Country
Australia
Secondary sponsor category [1] 3604 0
None
Name [1] 3604 0
Address [1] 3604 0
Country [1] 3604 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6092 0
Ethics committee address [1] 6092 0
Ethics committee country [1] 6092 0
Date submitted for ethics approval [1] 6092 0
23/03/2009
Approval date [1] 6092 0
Ethics approval number [1] 6092 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29036 0
Address 29036 0
Country 29036 0
Phone 29036 0
Fax 29036 0
Email 29036 0
Contact person for public queries
Name 12193 0
Dr Sumie Leung
Address 12193 0
Brain Sciences Institute
400 Burwood Rd
Hawthorn, VIC 3122
Country 12193 0
Australia
Phone 12193 0
+613 9214 5462
Fax 12193 0
+613 9214 5525
Email 12193 0
[email protected]
Contact person for scientific queries
Name 3121 0
Professor Rodney Croft
Address 3121 0
University of Wollongong
Northfields Avenue
Wollongong, NSW 2522
Country 3121 0
Australia
Phone 3121 0
+61 2 42213652
Fax 3121 0
+61 2 42214163
Email 3121 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.