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Trial registered on ANZCTR


Registration number
ACTRN12616000897460
Ethics application status
Approved
Date submitted
29/06/2016
Date registered
7/07/2016
Date last updated
22/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial to Examine the Effectiveness of Oxytocin to Improve Treatment for Anorexia Nervosa
Scientific title
A Randomised Controlled Trial to Examine the Effectiveness of Oxytocin to Improve Treatment for Anorexia Nervosa
Secondary ID [1] 289569 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anorexia nervosa 299299 0
Condition category
Condition code
Mental Health 299294 299294 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Daily dosing (28 days) of intra-nasal oxytocin (36 IU/day). Each dose session (one spray in each nostril, morning and night) will be monitored by a nurse using a dose diary and at the end of the trial the used vials will be collected and stored for future use to analyze unused contents (if necessary).
Intervention code [1] 295167 0
Treatment: Drugs
Comparator / control treatment
Placebo control, nasal spray without any active ingredients. Placebo contain the same contents as active sprays (distilled water, glycerol and sorbitol) without oxytocin.
Control group
Placebo

Outcomes
Primary outcome [1] 298785 0
To assess the efficacy of repeated dosing with IN-OT versus placebo in treating core eating disorder psychopathology change after 28 days of inpatient treatment. The Eating Disorders Examination, eating concern sub-scale will be used for this purpose (baseline vs day 28)
Timepoint [1] 298785 0
End of dosing, 28 days (4 weeks)
Secondary outcome [1] 325191 0
To assess the efficacy of the first (Day 1) and final daily dose of IN-OT (day 28, 4 weeks) in reducing food-related anxiety in response to a high-energy ‘fun food’ snack via saliva tests of cortisol and State-Trait Anxiety Inventory (short-form) given before and after the fun food snack.
Timepoint [1] 325191 0
after the first dose of IN-OT (day 1) and end of treatment (day 28)
Secondary outcome [2] 325343 0
Measure body mass index (BMI) for weight gain over the treatment trial and follow-up period
Timepoint [2] 325343 0
Baseline, day 28, one and six months follow-up
Secondary outcome [3] 325347 0
Change in cognitive rigidity after the treatment period using the Wisconsin Card Sort task
Timepoint [3] 325347 0
Day 28 (end of daily oxytocin or placebo treatment)
Secondary outcome [4] 325417 0
Change in cognitive rigidity using the Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS).
Timepoint [4] 325417 0
4 weeks and 6 month follow-up
Secondary outcome [5] 325418 0
Change in core eating disorder psychopathology using the Eating Disorders Examination (EDE, version 17) which has sub-scales for weight concern, shape concern and eating restraint
Timepoint [5] 325418 0
end of treatment (28 days, 4 weeks) and follow-up (6 months)
Secondary outcome [6] 325423 0
Treatment utilization will be collected using a self-report questionnaire to assess GP visits, medical services and days spent in hospital before and after the intervention
Timepoint [6] 325423 0
prior 6 months and 6 months follow-up

Eligibility
Key inclusion criteria
Anorexia nervosa requiring treatment in hospital for re-feeding
Minimum age
16 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Current mania, psychosis, acute suicidality or drug dependence,
severe medical comorbidity or major septal deviation to interfer with nasal delivery,
currently pregnant, or
Treated under the Mental health Act or Compulsory Treatment Orders (CTO)

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)
Yes, sequence generated by independent researcher in sealed (opaque) envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Initially, chi-square tests for categorical variables and Student’s t-tests for continuous variables will be conducted at each time point to assess significant group differences. Mixed effects models are often preferred over more traditional approaches such as repeated measures ANOVA because of their ability to deal with missing values. All randomised patients will be analysed according to the intention-to-treat principle. Continuous outcome measures will be analysed using multivariate analysis of variance (ANOVA) mixed models with repeated measurements. This will include interaction analyses of time (T1, T2, and T3) and type of treatment (OT vs. placebo) in order to evaluate effects over time.
From our pilot data we calculated Cohen's effect sizes for change in EDE global from baseline to week 6 to be 0.897. Using the standard power calculations of 80% power and alpha set at 0.05; the number required for a two-tailed test is 42 subjects (21 in each arm). Assuming 20% drop out, 50 subjects are required (25 in each arm) for the primary outcome variable. For the secondary outcomes we used the scores from the anorexia stages of change questionnaire to calculate effect sizes of 0.623; 84 subjects are needed (42 per group) or ~100 (50 in each arm) to accommodate for possible drop outs. Thus, the current study will plan to recruit a total of 120 subjects to ensure it is sufficiently powered for the planned analysis, we we are unsure how many will drop out at the 6 month follow-up.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/07/2016
Actual
23/01/2017
Date of last participant enrolment
Anticipated
1/12/2018
Actual
Date of last data collection
Anticipated
30/06/2019
Actual
Sample size
Target
120
Accrual to date
40
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 6036 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 6037 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 6038 0
Northside Clinic Private Hospital - Greenwich
Recruitment hospital [4] 6039 0
Wesley Hospital Ashfield - Ashfield
Recruitment hospital [5] 10091 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 13485 0
2050 - Camperdown
Recruitment postcode(s) [2] 13486 0
2065 - Greenwich
Recruitment postcode(s) [3] 13487 0
3084 - Heidelberg
Recruitment postcode(s) [4] 13488 0
2131 - Ashfield
Recruitment postcode(s) [5] 21627 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 293943 0
Government body
Name [1] 293943 0
National Health and Medical Research Council (NHMRC)
Country [1] 293943 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Sydney Medical School, Charles Perkins Centre
John Hopkins Drive
Camperdown, NSW 2006
Country
Australia
Secondary sponsor category [1] 292766 0
None
Name [1] 292766 0
Address [1] 292766 0
Country [1] 292766 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295356 0
Sydney Local Health District Ethics Review Committee (Royal Prince Alfred Hospital Zone)(EC00113)
Ethics committee address [1] 295356 0
Royal Prince Alfred Hospital
Research Ethics and Governance Office
Missenden Road
Camperdown, NSW, 2050
Ethics committee country [1] 295356 0
Australia
Date submitted for ethics approval [1] 295356 0
03/03/2015
Approval date [1] 295356 0
04/06/2015
Ethics approval number [1] 295356 0
HREC/15/RPAH/15, protocol number X15-0007
Ethics committee name [2] 295357 0
Northside Group Ethics Committee
Ethics committee address [2] 295357 0
Northside Clinic
2 Greenwich Road
Greenwich, NSW 2065
Ethics committee country [2] 295357 0
Australia
Date submitted for ethics approval [2] 295357 0
01/05/2015
Approval date [2] 295357 0
16/06/2015
Ethics approval number [2] 295357 0
X-0007
Ethics committee name [3] 299714 0
Royal Brisbane Womens Hospital
Ethics committee address [3] 299714 0
Metro North Hospital
Butterfield St
Herston QLD 4029
Ethics committee country [3] 299714 0
Australia
Date submitted for ethics approval [3] 299714 0
17/11/2017
Approval date [3] 299714 0
06/02/2018
Ethics approval number [3] 299714 0
HREC/15/RPAH/15_X15-0007

Summary
Brief summary
The main purpose of this study is to investigate the efficacy of intra-nasal oxytocin (IN-OT) as a single dose and in repeated dosage as an adjunct to nutritional rehabilitation in anorexia nervosa. We specifically want to determine the effects of IN-OT on weight gain, food-related anxiety, eating behaviour, core psychopathology eating concern, weight concern, shape concern and eating restraint) and cognitive rigidity additional to the effect of weight gain over 28 days then to assess these effects at six months follow up along with changes in body mass index (BMI) and health service utilisation.
Trial website
Trial related presentations / publications
Public notes
This study was previously registered in 2015 (ISRCTN11108405). The trial in the United Kingdom was stopped before ethical approval was sought due to funding and governance problems between the UK and Australia. The study will now only recruit participants in Australia.

Contacts
Principal investigator
Name 67018 0
Prof Janice Russell
Address 67018 0
Eating Disorders Unit
Northside Clinic
2 Greenwich Road
Greenwich, NSW 2065
Country 67018 0
Australia
Phone 67018 0
+612 9433 3555
Fax 67018 0
+612 9433 3599
Email 67018 0
[email protected]
Contact person for public queries
Name 67019 0
Sarah Maguire
Address 67019 0
Boden Institute, Charles Perkins Building
University of Sydney
Camperdown, 2006, NSW
Country 67019 0
Australia
Phone 67019 0
+612 9515-1523
Fax 67019 0
Email 67019 0
[email protected]
Contact person for scientific queries
Name 67020 0
Glenn Hunt
Address 67020 0
Discipline of Psychiatry
University of Sydney and
Concord Centre for Mental Health
Concord Hospital
Hospital Rd, Concord, NSW 2139
Country 67020 0
Australia
Phone 67020 0
+612 9767-8978
Fax 67020 0
+612 9767-8989
Email 67020 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

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