None listed
Conditions
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.
Interventions
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).
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Anorexia nervosa requiring treatment in hospital for re-feeding
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)
Outcome results
None listed