Examining the effectiveness of oxytocin in improving treatment for anorexia nervosa

Completed

Conditions: Anorexia nervosa.
Nutritional, Metabolic, Endocrine

Registration Number: ISRCTN11108405

Lead Sponsor: King's College London

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 30

Inclusion Criteria

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Motivation to change assessed using the Anorexia Nervosa Stages of Change Questionnaire (ANSOCQ) at pre (week 0) and post (week 4) intervention<br>2. Cognitive rigidity will be assessed using the Cognitive Flexibility Scale (CFS) and the Wisconsin Card <br>3. Sorting Test (WCST) at pre (week 0) and post (week 4) intervention<br>4. Service utilisation will be assessed in a follow-up interview at 1, 6 and 12 months follow-up<br>5. Functional outcomes will be assessed using the Morgan-Russell Average Outcome Scale (MRAOS) at 1, 6 and 12 months follow-up<br>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)