Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000310763
Ethics application status
Approved
Date submitted
8/03/2013
Date registered
20/03/2013
Date last updated
16/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
N-Acetyl Cysteine for the Treatment of Obsessive Compulsive Disorder (OCD): A Double-Blind, Randomised, Placebo-Controlled Clinical Trial
Scientific title
N-Acetyl Cysteine for the Treatment of Obsessive Compulsive Disorder (OCD)
Secondary ID [1] 282052 0
None
Universal Trial Number (UTN)
U1111-1140-0513
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obsessive Compulsive Disorder (OCD) 288526 0
Condition category
Condition code
Mental Health 288857 288857 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
N-acetyl cysteine (NAC): 500mg capsules taken orally - 1 capsule twice daily for 1 week, 2 capsules twice daily for the second week and 3 capsules twice daily (3g/day) for the remaining 13 weeks (total 16 weeks).
Intervention code [1] 286664 0
Treatment: Drugs
Comparator / control treatment
Placebo capsules taken in the same manner as the NAC, identical in appearance, which do not contain N-acetyl cysteine or any active component.
Control group
Placebo

Outcomes
Primary outcome [1] 289013 0
Severity in symptoms will be measured with the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Timepoint [1] 289013 0
Reviewed at baseline, week 4, 8, 12 and 16
Secondary outcome [1] 301849 0
nil
Timepoint [1] 301849 0
nil

Eligibility
Key inclusion criteria
Fulfil DSM-IV TR diagnostic criteria for OCD
Self reported OCD will require a diagnosis from a physician
Score 16+ on the Y-BOCS at the time of recruitment
No other treatment, or be on stable treatment i.e. minimum 4 weeks of treatment or minimum of 12 weeks if a new treatment (e.g. SSRI, CBT)
Female participants of child bearing age or sexually active are required to be using effective contraception
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known or suspected serious medical disorder i.e. cancer, organ failure
Patients undergoing current psychological programs for their OCD (a four week wash out period will be required for eligibility)
Bipolar I, schizophrenia, epilepsy
Gastrointestinal ulcers
Pregnancy or breastfeeding
History of hypersensitivity or intolerance to NAC
Patients taking 100 micrograms of selenium or 500 IU of vitamin E

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)
For potential subjects, a pre screening telephone interview will be completed to assess if they meet the criteria for the trial. If so, they will be invited to meet the clinician at the Melbourne Clinic for a baseline screening interview. By signing a consent form at this interview, which outlines the nature of the trial, and meeting the criteria at the baseline interview, they will become officially enrolled in the research project. The participants will be allocated a number and then randomised into the treatment group or placebo via a computer software program. The clinician will be unaware of which group the participant will be enrolled in. A person outside the project will then code the treatments and maintain the key to this code until data collection is completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be randomised into one of two groups determined by computerised random allocation using their participant number.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Statistical methods / analysis
The primary efficacy analysis will assess average treatment group differences for the primary outcome measure (Y-BOCS) using a mixed-effects model, repeated measures approach (MMRM). Results from the analysis of dichotomous data (e.g. demographics data) will be presented as proportions (e.g. Relative Risks), with 95% confidence interval, and Fisher’s Exact p-value where appropriate. Non-parametric statistics will be used when assumptions for parametric methods are violated. Effect sizes will be calculated using Cohen’s d. All tests of treatment effects will be conducted using a two-sided alpha level of 0.05 and 95% confidence intervals. Data analysed via SPSS 20.0.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/03/2013
Actual
13/03/2013
Date of last participant enrolment
Anticipated
1/08/2014
Actual
10/12/2014
Date of last data collection
Anticipated
Actual
8/04/2015
Sample size
Target
80
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 721 0
The Melbourne Clinic - Richmond

Funding & Sponsors
Funding source category [1] 286849 0
Self funded/Unfunded
Name [1] 286849 0
Country [1] 286849 0
Australia
Primary sponsor type
Hospital
Name
The Melbourne Clinic
Address
130 Church St Richmond, Melbourne, Victoria, 3121
Country
Australia
Secondary sponsor category [1] 285641 0
Commercial sector/Industry
Name [1] 285641 0
Bioceuticals
Address [1] 285641 0
Unit 16 37-41 O'Riordan St,
Alexandria, NSW
2015
Country [1] 285641 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288930 0
The Melbourne Clinic HREC
Ethics committee address [1] 288930 0
130 Church St, Richmond,
Melbourne,
VIC, 3121
Ethics committee country [1] 288930 0
Australia
Date submitted for ethics approval [1] 288930 0
Approval date [1] 288930 0
11/02/2013
Ethics approval number [1] 288930 0
219

Summary
Brief summary
The primary aim of this study is to investigate the efficacy and safety of adjunctive N-acetylcysteine (NAC) in the treatment of adults (n=80) with DSM-IV diagnosed OCD in a 16-week randomised, placebo-controlled trial. The primary outcome will be between group differences the severity of OCD symptoms on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).
Trial website
Trial related presentations / publications
N-Acetyl Cysteine (NAC) in the Treatment of Obsessive-Compulsive Disorder: A 16-Week, Double-Blind, Randomised, Placebo-Controlled Study; Jerome Sarris, Georgina Oliver, David A. Camfield, Olivia M. Dean, Nathan Dowling, Deidre J. Smith, Jenifer Murphy, Ranjit Menon, Michael Berk, Scott Blair-West, Chee H. Ng; CNS Drugs (2015) 29: 801.

Sarris, J., Oliver, G., Camfield, D. A., & Dean, O. M. (2016). Participant characteristics as modifiers of response to N-Acetyl cysteine (NAC) in Obsessive-Compulsive Disorder. Clinical Psychological Science, 4(6), 1104-1111.
Public notes

Contacts
Principal investigator
Name 38246 0
Dr Jerome Sarris
Address 38246 0
The Melbourne Clinic, 2 Salisbury st, Richmond, VIC, 3121
Country 38246 0
Australia
Phone 38246 0
+61404083393
Fax 38246 0
Email 38246 0
[email protected]
Contact person for public queries
Name 38247 0
Miss Gina Oliver
Address 38247 0
The Melbourne Clinic, 2 Salisbury st, Richmond, VIC, 3121
Country 38247 0
Australia
Phone 38247 0
+61 3 9487 4659
Fax 38247 0
Email 38247 0
[email protected]
Contact person for scientific queries
Name 38248 0
Miss Gina Oliver
Address 38248 0
The Melbourne Clinic, 2 Salisbury st, Richmond, VIC, 3121
Country 38248 0
Australia
Phone 38248 0
+61 3 9487 4659
Fax 38248 0
Email 38248 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
SourceTitleYear of PublicationDOI
EmbaseN-Acetyl Cysteine (NAC) in the Treatment of Obsessive-Compulsive Disorder: A 16-Week, Double-Blind, Randomised, Placebo-Controlled Study.2015https://dx.doi.org/10.1007/s40263-015-0272-9
N.B. These documents automatically identified may not have been verified by the study sponsor.