Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000671965
Ethics application status
Approved
Date submitted
1/07/2011
Date registered
4/07/2011
Date last updated
8/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Oxytocin on Cognitive Rigidity and Social Anxiety in Eating Disorders
Scientific title
The Effect of Oxytocin on Cognitive Rigidity and Social Anxiety in Eating Disorders: A Randomized Placebo
Controlled Trial of Oxytocin in the Treatment of Anorexia Nervosa
Secondary ID [1] 262410 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anorexia Nervosa 268205 0
Condition category
Condition code
Mental Health 268335 268335 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oxytocin nasal spray - Participants will receive 2 daily doses of oxytocin (36 International Units per day) for the duration of the entire trial, 6 weeks. The oxytocin will be administered in 2 puffs, one to each nostril, twice a day, each puff containing 9 International Units of oxytocin.
Intervention code [1] 266791 0
Treatment: Drugs
Comparator / control treatment
Placebo saline nasal spray - Participants will receive 2 daily doses of the placebo saline solution for the duration of the entire trial, 6 weeks. The placebo will be administered in the exact same way as the oxytocin (i.e. 2 puffs, one to each nostril, twice a day)
Control group
Placebo

Outcomes
Primary outcome [1] 269104 0
Level of social anxiety measured by The Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987)
Timepoint [1] 269104 0
Measured pre treatment (Week 0) and post treatment (week 6)
Primary outcome [2] 279872 0
Level of cognitive rigidity measured by the Brixton Task (Burgess and Shallice, 1997)
Timepoint [2] 279872 0
Measured pre treatment (Week 0) and post treatment (week 6)
Secondary outcome [1] 276943 0
Changes in cognitive functioning assessed using a range of measures including: 1. The Eye-Gaze Task (Guastella, Mitchell, & Dadds, 2008) 2. Reading the Mind in the Eyes Test (RMET, Baron-Cohen et al 2001) 3. Wisconsin Card Sorting Test (Heaton et al, 1993) 4. The Pictorial/Emotional Stroop task (Ashwin et al. 2006; Williams et al. 1996) 5. The Working Alliance Inventory-Short Form (Therapist and Participant versions) (Hatcher & Gillaspy, 2006) 6. The Obsessive-Compulsive Inventory-Revised (OCI-R; Foa et al., 2002)
Timepoint [1] 276943 0
Measured at four time points - pre-treatment (week 0), week 3, post treatment (week 6) and three week follow up at week 9.

Eligibility
Key inclusion criteria
Participants who meet DSM-IV diagnostic criteria for Anorexia Nervosa will be included in the study. Participants suffering from common comorbidities of depression and anxiety and Axis II disorders will be included in the study.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be exluded from the trial if they are suffering from any other major conditions, apart from those related to anorexia nervosa (i.e. common comorbidities of depression, anxiety and Axis II disorders)

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)
Persons attending day programs, inpatients and outpatients
with Anorexia Nervosa will be approached to participate in the study. Informed consent procedures will be followed in
recruiting persons to the study, parental consent will be sought for individuals 16 to 18 years of age. All potential participants in the study will have been screened using the Eating Disorder Examination 16th Edition (EDE 16.0D) to confirm diagnosis. Participants will be randomly assigned to the Oxytocin or Placebo Treatment by computer program. A
member of the Brain and Mind Research Institute, along side a compouding chemist, will be responsible for the random allocation of participants. Nobody at the data collection site will be aware of the group to which the participant has been allocated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software (i.e., computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/11/2011
Actual
6/01/2012
Date of last participant enrolment
Anticipated
Actual
12/12/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2300 0
Northside Clinic Private Hospital - Greenwich
Recruitment postcode(s) [1] 4176 0
2050

Funding & Sponsors
Funding source category [1] 267357 0
Charities/Societies/Foundations
Name [1] 267357 0
The Butterfly Foundation
Country [1] 267357 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The Centre for Eating and Dieting Disorders (CEDD)
Address
Derwent House, 1 - 3 Derwent St,
Glebe, NSW, 2031
Country
Australia
Secondary sponsor category [1] 266425 0
Hospital
Name [1] 266425 0
SYDNEY LOCAL HEALTH DISTRICT (SLHD)
Address [1] 266425 0
c/- RESEARCH DEVELOPMENT OFFICE, RPAH
MISSENDEN ROAD, CAMPERDOWN, NSW, 2050
Country [1] 266425 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269335 0
Sydney South West Area Health Service (SSWAHS) Royal Prince Alfred Hospital Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 269335 0
C/- Research Development Office
Level 3, Building 92 Royal Prince Alfred Hospital Missenden Rd
CAMPERDOWN NSW 2050
Ethics committee country [1] 269335 0
Australia
Date submitted for ethics approval [1] 269335 0
27/07/2011
Approval date [1] 269335 0
21/09/2011
Ethics approval number [1] 269335 0
Protocol Number X11-0153 and HREC/11/RPAH/220
Ethics committee name [2] 272076 0
Northside Group Ethics Committee
Ethics committee address [2] 272076 0
Northside Clinic, 2 Greenwich Rd
GREENWICH NSW 2065
Ethics committee country [2] 272076 0
Australia
Date submitted for ethics approval [2] 272076 0
29/07/2011
Approval date [2] 272076 0
04/10/2011
Ethics approval number [2] 272076 0
Protocol Number X11-0153

Summary
Brief summary
The main purpose of this study is to ascertain whether inhaled oxytocin might have therapeutic potential in reducing the cognitive rigidity and social anxiety that have been shown to be important perpetuating factors in Anorexia Nervosa. Participants will be analysed to determine whether oxytocin brings about any improvements in thinking which might help patients with Anorexia Nervosa to recover more easily.
Trial website
Trial related presentations / publications
Maguire, S., O'Dell, A., Touyz, S., & Russell, J. 2013. Oxytocin and Anorexia Nervosa: A review of the Emerging Literature. European Eating Disorders Review, 21, 475-478.

Workshop entitled 'Making Our Treatments Work (Better):
Neuropsychology, Neuroendocrine and Cognitive
Understandings and Strategies to Enhance
Treatment for Anorexia Nervosa'
Janice Russell, MD, FAED, Australia at the International Conference on Eating Disorders, March 2014, New York.
Public notes

Contacts
Principal investigator
Name 32755 0
Prof Janice Russell
Address 32755 0
The Boden Institute of Obesity, Nutrition, Exercise & Eating Disorder, The University of Sydney Ground Floor, Medical Foundation Bldg (K25) 92-94 Parramatta Road Camperdown, NSW 2006
Country 32755 0
Australia
Phone 32755 0
+61 2 97362288
Fax 32755 0
Email 32755 0
[email protected]
Contact person for public queries
Name 16002 0
Miss Lauren Touyz
Address 16002 0
The Boden Institute, The University of Sydney
Ground Floor, Medical Foundation Building (K25)
92-94 Parramatta Rd
Camperdown NSW 2050
Country 16002 0
Australia
Phone 16002 0
+61 2 90363069
Fax 16002 0
+61 2 90363176
Email 16002 0
[email protected]
Contact person for scientific queries
Name 6930 0
Miss Lauren Touyz
Address 6930 0
The Boden Institute, The University of Sydney
Ground Floor, Medical Foundation Building (K25)
92-94 Parramatta Rd
Camperdown NSW 2050
Country 6930 0
Australia
Phone 6930 0
+61 2 90363069
Fax 6930 0
Email 6930 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
EmbaseIntranasal oxytocin in the treatment of anorexia nervosa: Randomized controlled trial during re-feeding.2018https://dx.doi.org/10.1016/j.psyneuen.2017.10.014
N.B. These documents automatically identified may not have been verified by the study sponsor.