Examining the effectiveness of oxytocin in improving treatment for anorexia nervosa

A randomised controlled trial to examine the effectiveness of oxytocin to improve treatment for anorexia nervosa

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11108405

Enrollment

Registered

2015-08-06

Start date

2015-07-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia nervosa. Nutritional, Metabolic, Endocrine

Interventions

This project will use a randomized double blind placebo-controlled design to compare the effects of repeated twice daily-dosing of intra-nasal oxytocin as an adjunct to inpatient nutritional rehabilit

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Female and fluent in English 2. Diagnosis of eating disorders (anorexia nervosa)

Exclusion criteria

Exclusion criteria: 1. Non-proficiency in the English language (as needed for neuropsychological tests) 2. IQ <80 (National Adult Reading Test; NART) 3. Currently pregnant 4. Current manic episode or psychosis 5. Current alcohol, substance abuse or dependence 6. Acute suicidality 7. Significant medical or neurological disorders not relating to their primary diagnosis of AN 8. Conditions such as major septal deviation or other nasal conditions 9. Patients being treated under the Mental Health Act or under compulsory treatment orders 10. Patients previously given OT or those with planned stays in hospital of less than 4 weeks 11. Patients with an ECG of less than 40 beats per minute to avoid the potential hypotensive effects of OT

Design outcomes

Primary

Measure	Time frame
Core eating disorder psychopathology and BMI will be measured using the Eating Disorder Examination semi-structured interview and height and weight measurements at pre (week 0) and post (week 4) intervention, as well as at 1, 6 and 12 months follow-up.	—

Secondary

Measure	Time frame
1. Motivation to change assessed using the Anorexia Nervosa Stages of Change Questionnaire (ANSOCQ) at pre (week 0) and post (week 4) intervention 2. Cognitive rigidity will be assessed using the Cognitive Flexibility Scale (CFS) and the Wisconsin Card 3. Sorting Test (WCST) at pre (week 0) and post (week 4) intervention 4. Service utilisation will be assessed in a follow-up interview at 1, 6 and 12 months follow-up 5. Functional outcomes will be assessed using the Morgan-Russell Average Outcome Scale (MRAOS) at 1, 6 and 12 months follow-up 6. Pre and post snack VAS anxiety scores, and salivary cortisol, alpha-amylase and OT will be assessed in the two embedded single-dose studies on day 1 (week 0) and day 28 (week 4)	—

Measure

Time frame

1. Motivation to change assessed using the Anorexia Nervosa Stages of Change Questionnaire (ANSOCQ) at pre (week 0) and post (week 4) intervention 2. Cognitive rigidity will be assessed using the Cognitive Flexibility Scale (CFS) and the Wisconsin Card 3. Sorting Test (WCST) at pre (week 0) and post (week 4) intervention 4. Service utilisation will be assessed in a follow-up interview at 1, 6 and 12 months follow-up 5. Functional outcomes will be assessed using the Morgan-Russell Average Outcome Scale (MRAOS) at 1, 6 and 12 months follow-up 6. Pre and post snack VAS anxiety scores, and salivary cortisol, alpha-amylase and OT will be assessed in the two embedded single-dose studies on day 1 (week 0) and day 28 (week 4)

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026