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Trial registered on ANZCTR


Registration number
ACTRN12617001140347
Ethics application status
Approved
Date submitted
1/08/2017
Date registered
4/08/2017
Date last updated
12/02/2021
Date data sharing statement initially provided
13/06/2019
Date results information initially provided
12/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A nutrient combination in the treatment of Obsessive-Compulsive Disorder
Scientific title
Treatment of Refractory Obsessive-Compulsive Disorder with Nutraceuticals
Secondary ID [1] 292573 0
None
Universal Trial Number (UTN)
Trial acronym
The 'TRON' study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Treatment-Refractory Obsessive-Compulsive Disorder 304240 0
Condition category
Condition code
Mental Health 303592 303592 0 0
Other mental health disorders
Alternative and Complementary Medicine 303602 303602 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All enrolled participants will receive the following nutrient supplements for the 20 weeks of the study:
*Compounded N-acetylcysteine (NAC) and L-theanine (LT) capsules, 500mg and 100mg per capsule respectively. Two capsules taken twice per day (2,000mg NAC and 400mg LT per day). Dose will be titrated to three capsules, twice per day in cases of non-response from Week-8 in the study (non-response defined as < 35% reduction in Week-8 Y-BOCS score in comparison to baseline).
*Zinc liquid (25 drops per day, 28.4mg elemental zinc per day)
*Selenium liquid (5 drops per day, 113mcg elemental selenium per day)
*Magnesuim and Vitamin B6 tablets (1 tablet per day, 150 elemental magnesium, 50mg pyridoxal-5-phosphate).

Participants will be asked to return their nutrient supplements at each follow-up visit where capsules/tablets will be counted, and liquid measured to determine compliance. New supplements will be dispensed at each visit as required.
Intervention code [1] 298776 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302945 0
The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
Timepoint [1] 302945 0
Administered at baseline, Week-4, Week-8, Week-12, Week-16 and Week-20 end point
Secondary outcome [1] 337522 0
The Structured Interview Guide for the Hamilton Depression Rating Scale (17 item)
Timepoint [1] 337522 0
Baseline, Week-4, Week-8, Week-12, Week-16, Week-20
Secondary outcome [2] 337523 0
Beck Anxiety Inventory (self-reported measure)
Timepoint [2] 337523 0
Baseline, Week-4, Week-8, Week-12, Week-16, Week-20
Secondary outcome [3] 337525 0
Dimensional Obsessive-Compulsive Scale (DOCS)
Timepoint [3] 337525 0
Baseline, Week-4, Week-8, Week-12, Week-16, Week-20
Secondary outcome [4] 337527 0
World Health Organisation Quality of Life questionnaire (Brief)
Timepoint [4] 337527 0
Baseline, Week-12 and Week-20
Secondary outcome [5] 337529 0
Clinician Global Impression (CGI) scale
Timepoint [5] 337529 0
Baseline, Week-4, Week-8, Week-12, Week-16, Week-20
Secondary outcome [6] 337555 0
Patient Global Impression (PGI) scale
Timepoint [6] 337555 0
Baseline, Week-4, Week-8, Week-12, Week-16, Week-20

Eligibility
Key inclusion criteria
*18-75 years of age
*Y-BOCS score of equal to or greater than 16 at time of entry into the study
*Treatment-Refractory OCD (defined as inadequate response to 1. at least 3 trials to serotonin-reuptake inhibitor medications; 2. an augmentation trial, for example, an antipsychotic medication; 3. at least 15 sessions of cognitive and/or behavioural therapy with an experienced clinician OR completion of one in-patient program specific for OCD treatment.
*Stable treatment for the previous 4 weeks (for example, consistent doses of medications used for their OCD, regular appointments with psychologist for behavioural therapy) OR not currently employing treatment for their OCD
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Diagnosis of bipolar disorder
*Diagnosis of psychotic disorder
*Strong suicidal ideation (defined as Hamilton Depression rating scale, item-3 score equal to or greater than 3)
*Diagnosis of alcohol or substance abuse
*Medications with known or suspected interactions with any of the investigated nutrients, to be determined by the medical investigators on a case by case basis
*Allergy to any component of the investigational products
*Serious or unstable medical conditions, to be determined by the medical investigators on a case by case basis
*Gastrointestinal ulcers or renal stones within the last 2 years
*Pregnancy of women currently breastfeeding

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Statistical methods / analysis
A sample size of 70 participants across three study sites are anticipated to be recruited and intention-to-treat principles will be applied to all data. Given this is a pilot, open-label study in a highly resistant to treatment population we are expecting a small effect size. Analysis of all outcome measures will be performed at each time point and intention-to-treat statistical analysis employed. Repeated measures linear mixed models analysis will be used to test the effect on rate of change on primary and secondary outcome measures over time. Tests of significance will use a level of alpha = 0.05. Data will be analysed via SPSS 24.0

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)
NSW,QLD,VIC
Recruitment hospital [1] 8676 0
The Melbourne Clinic - Richmond
Recruitment hospital [2] 8677 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 16786 0
3121 - Richmond
Recruitment postcode(s) [2] 16787 0
4029 - Herston
Recruitment postcode(s) [3] 26763 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 297152 0
University
Name [1] 297152 0
Western Sydney University
Address [1] 297152 0
Western Sydney University
Westmead Campus
158-160 Hawkesbury Rd
Westmead
NSW, 2145
Country [1] 297152 0
Australia
Primary sponsor type
Individual
Name
Prof Jerome Sarris
Address
Western Sydney University
Westmead Campus
158-160 Hawkesbury Rd
Westmead
NSW, 2145
Country
Australia
Secondary sponsor category [1] 296166 0
None
Name [1] 296166 0
None
Address [1] 296166 0
Not applicable
Country [1] 296166 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298319 0
The Melbourne Clinic Research Ethics Committee
Ethics committee address [1] 298319 0
130 Church St,
Richmond, VIC, 3121
Ethics committee country [1] 298319 0
Australia
Date submitted for ethics approval [1] 298319 0
11/11/2016
Approval date [1] 298319 0
13/03/2017
Ethics approval number [1] 298319 0
TMCREC project number 290
Ethics committee name [2] 303582 0
WSU HREC
Ethics committee address [2] 303582 0
Human Ethics Officer
Research Engagement, Development and Innovation (REDI)
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Ethics committee country [2] 303582 0
Australia
Date submitted for ethics approval [2] 303582 0
11/07/2017
Approval date [2] 303582 0
18/09/2017
Ethics approval number [2] 303582 0
H12331
Ethics committee name [3] 303583 0
UQ HREC
Ethics committee address [3] 303583 0
Level 3, Brian Wilson Chancellery
The University of Queensland
St Lucia QLD 4072, Australia
Ethics committee country [3] 303583 0
Australia
Date submitted for ethics approval [3] 303583 0
24/01/2018
Approval date [3] 303583 0
11/05/2018
Ethics approval number [3] 303583 0
2018000339

Summary
Brief summary
The study will assess the effects of a nutrient supplement (nutraceutical) combination in individuals with treatment-refractory obsessive-compulsive disorder. The study is a 5 month, open-label, multicentre pilot study.
Trial website
None
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76702 0
Prof Jerome Sarris
Address 76702 0
NICM Health Research Institute
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Australia
Country 76702 0
Australia
Phone 76702 0
+61 2 4620 3284
Fax 76702 0
Email 76702 0
J.Sarris@westernsydney.edu.au
Contact person for public queries
Name 76703 0
Ms Georgina Oliver
Address 76703 0
The Melbourne Clinic
Professorial Unit
2 Salisbury St,
Richmond, VIC, 3121
Country 76703 0
Australia
Phone 76703 0
+61 3 9487 4659
Fax 76703 0
Email 76703 0
georgina.oliver@unimelb.edu.au
Contact person for scientific queries
Name 76704 0
Ms Georgina Oliver
Address 76704 0
The Melbourne Clinic
Professorial Unit
2 Salisbury St,
Richmond, VIC, 3121
Country 76704 0
Australia
Phone 76704 0
+61 3 9487 4659
Fax 76704 0
Email 76704 0
georgina.oliver@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants have not consented to provide IPD
What supporting documents are/will be available?
Clinical study report
How or where can supporting documents be obtained?
Type [1] 257 0
Clinical study report
Citation [1] 257 0
Link [1] 257 0
Email [1] 257 0
Other [1] 257 0
A clinical study report will be provided when the study has been completed
Attachment [1] 257 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary