Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000363684
Ethics application status
Approved
Date submitted
29/08/2005
Date registered
12/09/2005
Date last updated
12/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
N-acetyl cysteine in schizophrenia: A double blind randomised placebo controlled trial
Scientific title
N-acetyl cysteine in Schizophrenia:A double blind randomised placebo
controlled trial investigating a range of psychiatric rating scales
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 458 0
Condition category
Condition code
Mental Health 535 535 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a six month study with a four to six week post-disconinuation visit. The trial involves taking 2g of n-acetyl cysteine per day in addition to the participant's usual treatment.
Intervention code [1] 284 0
None
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 615 0
PANSS
Timepoint [1] 615 0
Used at each of the 10 visits over a 6 month period.
Primary outcome [2] 616 0
GAF
Timepoint [2] 616 0
Used at each of the 10 visits over a 6 month period.
Primary outcome [3] 617 0
SOFAS
Timepoint [3] 617 0
Used at each of the 10 visits over a 6 month period.
Primary outcome [4] 618 0
CGI
Timepoint [4] 618 0
Used at each of the 10 visits over a 6 month period.
Primary outcome [5] 619 0
Cognitive testing
Timepoint [5] 619 0
Used at each of the 10 visits over a 6 month period.
Primary outcome [6] 620 0
Assessment of involuntary movements
Timepoint [6] 620 0
Used at each of the 10 visits over a 6 month period.
Secondary outcome [1] 1290 0
Safety data such as blood pressure, BMI, and routine blood testing.
Timepoint [1] 1290 0
Blood pressure and BMI are taken at each visit whereas blood collection/testing is carried out at baseline and two months into the trial.

Eligibility
Key inclusion criteria
DSM-IV diagnosis of schizophrenia, have a PANSS score of >55 or at least two items in the positive and/or negative items being >3 AND/OR have a CGI-S >3, be utilising effective contraception if of child-bearing age.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Taking mood stabilisers, asthma or history of respiratory insufficiency/allergy to n-acetyl cysteine, abnormal heamotological findings, or systemic medical disorder, currently taking either 500mg of NAC/day, 200ug of selenium/day or 500 IU of Vitamin E/day or inability to comply with the informed consent.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 593 0
Other
Name [1] 593 0
Stanley Medical Research Institute Grant
Country [1] 593 0
United States of America
Primary sponsor type
Other
Name
Stanley Medical Research Institute
Address
Country
United States of America
Secondary sponsor category [1] 482 0
Other
Name [1] 482 0
Mental Health Research Institute
Address [1] 482 0
Country [1] 482 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1684 0
Barwon Health
Ethics committee address [1] 1684 0
Ethics committee country [1] 1684 0
Australia
Date submitted for ethics approval [1] 1684 0
Approval date [1] 1684 0
Ethics approval number [1] 1684 0
Ethics committee name [2] 1685 0
Bendigo Health Care Group
Ethics committee address [2] 1685 0
Ethics committee country [2] 1685 0
Australia
Date submitted for ethics approval [2] 1685 0
Approval date [2] 1685 0
Ethics approval number [2] 1685 0
Ethics committee name [3] 1686 0
Lausanne
Ethics committee address [3] 1686 0
Ethics committee country [3] 1686 0
Switzerland
Date submitted for ethics approval [3] 1686 0
Approval date [3] 1686 0
Ethics approval number [3] 1686 0
Ethics committee name [4] 1687 0
Ballarat Health Services
Ethics committee address [4] 1687 0
Ethics committee country [4] 1687 0
Australia
Date submitted for ethics approval [4] 1687 0
Approval date [4] 1687 0
Ethics approval number [4] 1687 0
Ethics committee name [5] 1688 0
South West Area Mental Health Service (Werribee)
Ethics committee address [5] 1688 0
Ethics committee country [5] 1688 0
Australia
Date submitted for ethics approval [5] 1688 0
Approval date [5] 1688 0
Ethics approval number [5] 1688 0

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

Contacts
Principal investigator
Name 35729 0
Address 35729 0
Country 35729 0
Phone 35729 0
Fax 35729 0
Email 35729 0
Contact person for public queries
Name 9473 0
Ms. Olivia Dean
Address 9473 0
The Geelong Hospital
Kitchener House
PO Box 281
Geelong VIC 3220
Country 9473 0
Australia
Phone 9473 0
+61 3 52267428
Fax 9473 0
Email 9473 0
odean@mhri.edu.au
Contact person for scientific queries
Name 401 0
Prof. Michael Berk
Address 401 0
The Geelong Hospital
Kitchener House
PO Box 281
Geelong VIC 3220
Country 401 0
Australia
Phone 401 0
+61 3 52603154
Fax 401 0
Email 401 0
mikebe@barwonhealth.org.au

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.