Examining the effectiveness of oxytocin in improving treatment for anorexia nervosa
| ISRCTN | ISRCTN11108405 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11108405 |
| Secondary identifying numbers | N/A |
- Submission date
- 22/06/2015
- Registration date
- 06/08/2015
- Last edited
- 18/11/2015
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
Anorexia nervosa (AN) is a major social and public health problem with the highest death rate and treatment costs of any psychiatric disorder. Effective nutritional rehabilitation programs exist but are costly and protracted, and patients struggle to engage and persevere. There is an urgent need for a safe, inexpensive, easily administered treatment to help nutritional rehabilitation programs work better and encourage patients to comply with them. The purpose of this study is to investigate a novel pharmacotherapy, intranasal oxytocin (INOT) and its effects on patients with anorexia nervosa participating in a nutritional rehabilitation program. Oxytocin (OT) has shown promise in treating some forms of mental illness through its prosocial and anxiolytic (anxiety lowering) effects.
Who can participate?
Adult women diagnosed with AN and fluent in English, recruited in Sydney (Austria) and London (UK).
What does the study involve?
All inpatients at both clinics are given the study information sheet and provided with an opportunity to ask any questions they might have about the study. If a patient decides to take part in the trial they are provided with further information, screened for eligibility and asked to sign a consent form. The participant is then randomised into either the oxytocin (intervention) or placebo (control) group. Each participant is asked to participant in an initial assessment at the start of the study to assess how severe their eating disorder is, and their neuropsychological (brain) functioning. They are then asked to take part in two embedded single dose studies at the beginning and at the end of the trial. The single dose studies involve each participant giving themselves 18 IU of oxytocin or placebo before eating a afternoon snack and completing a questionnaire measuring anxiety. This same procedure is repeated at the end of the trial (57th dose). After the first embedded single dose study the main trial begins, during which participants are asked to self-administer intra-nasal oxytocin (18 IU) or placebo twice a day (at 10am and 3pm) under the supervision of a medically trained member of the research team. Participants are monitored throughout the trial for adverse reactions by a medically trained member of the research team as well as by clinic staff. After the trial has finished participants are followed up at regular intervals (1, 6 and 12 months) to assess outcome and service use (e.g. eating disorder related visits to the GP).
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Bethlem Royal Hospital (London) and Biden Institute (Australia)
When is the study starting and how long is it expected to run for?
May 2015 to July 2017
Who is funding the study?
National Health and Medical Research Council (Australia)
Who is the main contact?
Professor Janet Treasure
janet.treasure@kcl.ac.uk
Contact information
Scientific
Section of Eating Disorders
Institute of Psychiatry, Psychology and Neuroscience
King's College
London
SE5 8AF
United Kingdom
 ORCID ID |
0000-0003-0871-4596 |
|---|
Study information
| Study design | A randomized double blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A randomised controlled trial to examine the effectiveness of oxytocin to improve treatment for anorexia nervosa |
| Study hypothesis | Primary Aim. To assess the efficacy of repeated dosing with intra-nasal oxytocin (INOT) versus placebo in treating core eating disorder psychopathology and in improving response to nutritional rehabilitation across 28 days of inpatient treatment. Hypothesis 1: Patients treated with daily IN¬OT (36 IU per day) will show greater improvements in core eating disorder psychopathology and disordered eating behaviours with greater gains in BMI across inpatient treatment. Secondary Aims: To assess the efficacy of the first and final daily dose of INOT in reducing food related anxiety in response to a high energy snack. Hypothesis 2: Oxytocin (OT) treated patients will display lower levels of pre snack anxiety, show reduced levels of salivary cortisol and alpha-amylase in anticipation of a high energy snack compared to patients who received placebo after the initial dose and after repeated dosing with INOT. Aim 3: To assess the effects of repeated dosing with INOT on motivation and cognition during inpatient nutritional rehabilitation treatment for AN. Hypothesis 3: Patients receiving repeated treatment with INOT will display improved motivation to change and reduced cognitive rigidity relative to placebo after 28 days of inpatient treatment. Aim 4: To assess the longterm impact of chronic (4 weeks) INOT treatment on 1, 6 and 12 month outcomes. Hypothesis 4: INOT treated patients will show continued gains, less service utilisation (days in hospital, medical and emergency presentations) and improved functional outcomes at 1, 6 and 12 months compared to those in the placebo group. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Anorexia nervosa. |
| Intervention | 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 rehabilitation treatment. Both oxytocin and placebo arms will receive standard inpatient treatment. The average minimum inpatient treatment stay of 4 weeks (28 days) will be used as the intervention period to ensure compliance with dosing and to minimise drop-outs. Participants will 36 IU of oxytocin delivered in two daily (18IU each) doses intra-nasally for the entire 4 weeks. Embedded within the overall design, will be a Single Dose Study whereby the effects of the first and final dose (57th dose) of oxytocin on anxiety and stress related to feeding, and disordered eating behaviour, will be specifically evaluated. |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 | 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) |
| Overall study start date | 01/05/2015 |
| Overall study end date | 01/07/2017 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 30 |
| Participant inclusion criteria | 1. Female and fluent in English 2. Diagnosis of eating disorders (anorexia nervosa) |
| Participant 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 |
| Recruitment start date | 01/07/2015 |
| Recruitment end date | 01/07/2017 |
Locations
Countries of recruitment
- Australia
- England
- United Kingdom
Study participating centres
Beckenham
London
BR3 3BX
United Kingdom
University of Sydney
Sydney
NSW 2006
Australia
Sponsor information
University/education
Dir. Research Management
Dir. Administration (Health Schools)
Room 1.8 Hodgkin Building
Guy's Campus
King's College London
London
SE1 4UL
England
United Kingdom
"ROR" |
https://ror.org/0220mzb33 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NHMRC
- Location
- Australia
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | It is intended that the results of the study will be reported and disseminated at international conferences and in peer-reviewed scientific journals. No dates as of yet. |
| IPD sharing plan |
Editorial Notes
18/11/2015: The trial has been abandoned to due difficulties securing funding for the study.
