Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000362695
Ethics application status
Approved
Date submitted
29/08/2005
Date registered
12/09/2005
Date last updated
14/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Antioxidants in bipolar disorder: A double blind randomised placebo controlled trial of n-acetyl cysteine.
Scientific title
Antioxidants in Bipolar Disorder: A double blind randomised placebo
controlled trial investigating n-acetyl cysteine effects on a range of
psychiatric rating scales
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar disorder 457 0
Condition category
Condition code
Mental Health 533 533 0 0
Other mental health disorders
Neurological 534 534 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a six month treatment study with a four to six week post-discontinuation visit. The trial involves 2g of n-acetyl cysteine per day in addition to the participants usual treatment.
Intervention code [1] 282 0
None
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 614 0
Time to intervention for mood episode
Timepoint [1] 614 0
When occurred
Secondary outcome [1] 1282 0
YMRS
Timepoint [1] 1282 0
At each trial visit. (Total of nine visits).
Secondary outcome [2] 1283 0
BDRS
Timepoint [2] 1283 0
At each trial visit. (Total of nine visits).
Secondary outcome [3] 1284 0
Q-LES-Q
Timepoint [3] 1284 0
At each trial visit. (Total of nine visits).
Secondary outcome [4] 1285 0
Slice/life
Timepoint [4] 1285 0
At each trial visit. (Total of nine visits).
Secondary outcome [5] 1286 0
Life/rift
Timepoint [5] 1286 0
At each trial visit. (Total of nine visits).
Secondary outcome [6] 1287 0
SOFAS
Timepoint [6] 1287 0
At each trial visit. (Total of nine visits).
Secondary outcome [7] 1288 0
CGI
Timepoint [7] 1288 0
At each trial visit. (Total of nine visits).
Secondary outcome [8] 1289 0
GAF
Timepoint [8] 1289 0
At each trial visit. (Total of nine visits).

Eligibility
Key inclusion criteria
DSM-IV diagnosis of bipolar disorder (I, II or NOS), have had at least one mood episode within the last 12 months, have been on stable treatment for one month, have the capacity to consent and be on effective contraception.
Minimum age
Not stated
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Asthma, history of ulcers, respiritory insufficiency, any current systemic medical disorder, participants who are currently taking either 500mg of NAC/day, 200ug of selenium/day or 500 IU of Vitamin E/day and women pregnant or lactacting.

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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 592 0
Other
Name [1] 592 0
Research Funds
Country [1] 592 0
Australia
Primary sponsor type
Other
Name
Research Funds
Address
Victoria, Australia
Country
Australia
Secondary sponsor category [1] 481 0
Other
Name [1] 481 0
Mental Health Research Institute
Address [1] 481 0
Parkville, Melbourne, Australia
Country [1] 481 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1681 0
Barwon Health
Ethics committee address [1] 1681 0
Ethics committee country [1] 1681 0
Australia
Date submitted for ethics approval [1] 1681 0
Approval date [1] 1681 0
Ethics approval number [1] 1681 0
Ethics committee name [2] 1682 0
Bendigo Health Care Group
Ethics committee address [2] 1682 0
Ethics committee country [2] 1682 0
Australia
Date submitted for ethics approval [2] 1682 0
Approval date [2] 1682 0
Ethics approval number [2] 1682 0
Ethics committee name [3] 1683 0
South West Area Mental Health Service (Werribee)
Ethics committee address [3] 1683 0
Ethics committee country [3] 1683 0
Australia
Date submitted for ethics approval [3] 1683 0
Approval date [3] 1683 0
Ethics approval number [3] 1683 0

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

Contacts
Principal investigator
Name 35613 0
Address 35613 0
Country 35613 0
Phone 35613 0
Fax 35613 0
Email 35613 0
Contact person for public queries
Name 9471 0
Ms. Olivia Dean
Address 9471 0
The Geelong Hospital
Kitchener House
PO Box 281
Geelong VIC 3220
Country 9471 0
Australia
Phone 9471 0
+61 3 93892973
Fax 9471 0
Email 9471 0
[email protected]
Contact person for scientific queries
Name 399 0
Prof. Michael Berk
Address 399 0
The Geelong Hospital
Kitchener House
PO Box 281
Geelong VIC 3220
Country 399 0
Australia
Phone 399 0
+61 3 52603154
Fax 399 0
Email 399 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.