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Trial registered on ANZCTR


Registration number
ACTRN12607000074493
Ethics application status
Approved
Date submitted
19/01/2007
Date registered
23/01/2007
Date last updated
27/04/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A double blind randomised placebo controlled trial of NAC in bipolar disorder.
Scientific title
An investigation of the effects of n-acetyl cysteine in bipolar disorder based on time to intervention for mood symptoms and a range of psychiatric rating scales.
Secondary ID [1] 260067 0
NAC BD2
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar disorder 1566 0
Condition category
Condition code
Mental Health 1667 1667 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral n-acetyl cysteine (NAC) treatment (2 grams per day) will be provided in an open label design for the first two months. Participants will continue on the trial for an additional six months and will be randomly assigned to NAC.
Intervention code [1] 1568 0
Treatment: Drugs
Comparator / control treatment
In an additional six months trial, participants will be randomly assigned to placebo.
Control group
Placebo

Outcomes
Primary outcome [1] 2307 0
Time to intervention for mood symptoms will be the primary outcome for this study.
Timepoint [1] 2307 0
Assessed following the open label phase, at each monthly visit for the duration of the randomised trial (six months).
Secondary outcome [1] 4027 0
Secondary outcomes include but are not limited to the following rating scales; Montgomery-Asberg Depression Rating Scale (MADRS), Bipolar Depression Rating Scale (BDRS), Young Mania Rating Scale (YMRS), Clincial Global Impression (CGI) improvement and severity scales, Clinical Global Impression for Bipolar Disorder (CGIBP), Global Assessment of Functioning Scale (GAF), Social and Occupational Functioning Assessment Scale (SOFAS), Streamlined Longitudinal Interview Clinical Evaluation from the Longitudinal Interval Follow-up Evaluation (SLICE/LIFE), Range of Impaired Functioning Tool (LIFE/RIFT), Life Functioning Questionairre (LFQ), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), cognitive testing, and investigations of blood for oxidative markers.
Timepoint [1] 4027 0
These will be assessed during the open label phase (three fortnightly visits) and at each visit of the randomised trial (six monthly visits).

Eligibility
Key inclusion criteria
Meeting Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for bipolar disorder, have current symtpoms of depression with a Montgomery-Asberg Depression Rating Scale (MADRS) score over 12 at baseline, have the capacity to consent, be on stable therapy for at least one month prior to randomisation.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals with a known or suspected clinically relevant medical disorder, elderly individuals with respiratory insufficiency, individuals who are pregnant or lactating, individuals currently taking greater than 500 mg/day of NAC, 200 ug of slenium/day or 500 International Units (IU) of vitamin E/day, individuals who have had previous anaphylactic reactions to NAC or any component of the preparation.

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)
Treatments were randomly assigned into pack numbers by an individual independent of participant recruitment. Trial clincians recruited particpants and allocated them sequential pack numbers thereby adhering to double blind procedures.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatments were allocated into pack numbers by a simple coin tossing method. Participants were then recruited and allocated sequential pack numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Initially all participants will be on open label treatment followed by a double blind randomised placebo controlled trial. Trial clinicians and participants will be blinded to the randomised treatment. Participants will be unaware of any change in trial treatment. Data analysis will be conducted under blind conditions.
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 1812 0
Other
Name [1] 1812 0
Stanley Medical Research Institute Grant
Address [1] 1812 0
8401 Connecticut Avenue, Suite 200
Chevy Chase, MD 20815
Country [1] 1812 0
United States of America
Primary sponsor type
Other
Name
Stanley Medical Research Institute
Address
8401 Connecticut Avenue, Suite 200
Chevy Chase, MD 20815
Country
United States of America
Secondary sponsor category [1] 1634 0
Other
Name [1] 1634 0
Mental Health Research Institute
Address [1] 1634 0
155 Oak Street, Parkville VIC 3052
Country [1] 1634 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3397 0
Barwon Health
Ethics committee address [1] 3397 0
Ethics committee country [1] 3397 0
Australia
Date submitted for ethics approval [1] 3397 0
Approval date [1] 3397 0
11/08/2004
Ethics approval number [1] 3397 0
04/54
Ethics committee name [2] 3398 0
Southwestern Mental Health Service
Ethics committee address [2] 3398 0
Ethics committee country [2] 3398 0
Australia
Date submitted for ethics approval [2] 3398 0
Approval date [2] 3398 0
31/05/2005
Ethics approval number [2] 3398 0
R04/58W
Ethics committee name [3] 3399 0
Bendigo Health Care Group
Ethics committee address [3] 3399 0
Ethics committee country [3] 3399 0
Australia
Date submitted for ethics approval [3] 3399 0
Approval date [3] 3399 0
22/11/2004
Ethics approval number [3] 3399 0
CT01/04

Summary
Brief summary
To evaluate the efficacy of n-acetyl cysteine treatment in individuals with bipolar disorder who are continuing treatment as usual with the adjuct of n-acetyl cysteine treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27502 0
Address 27502 0
Country 27502 0
Phone 27502 0
Fax 27502 0
Email 27502 0
Contact person for public queries
Name 10757 0
Professor Michael Berk
Address 10757 0
The Geelong Hospital
Kitchener House
PO Box 281
Geelong VIC 3220
Country 10757 0
Australia
Phone 10757 0
+61 3 52603154
Fax 10757 0
Email 10757 0
mikebe@barwonhealth.org.au
Contact person for scientific queries
Name 1685 0
Professor Michael Berk
Address 1685 0
The Geelong Hospital
Kitchener House
PO Box 281
Geelong VIC 3220
Country 1685 0
Australia
Phone 1685 0
+61 3 52603154
Fax 1685 0
Email 1685 0
mikebe@barwonhealth.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary