A Double-Blinded, 4-Arm, Covariate-Adjusted Adaptive Clinical Trial Evaluating the Efficacy of Novel Pharmacological Agents for the Treatment of Anorexia Nervosa in Individuals Aged 16 and Over

Monash University0 sites100 target enrollmentSeptember 20, 2023

Overview

No summary available.

Registry

who.int

Start Date

September 20, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•1\.Diagnosis of anorexia nervosa (restrictive or binge\-eating/purging subtype), in accordance with the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM\-5\).
•2\.16 years or older in age.
•3\.Baseline body mass index (BMI) of equal to or greater than 14
•4\.Demonstrated capacity to give informed consent.
•5\.No initiation of therapies targeting AN within the 4 weeks prior to screening. This includes pharmacological and psychological therapies.
•6\.No increase or initiation of medications with appetite suppressing and/or weight loss effects within the 4 weeks prior to screening.
•7\.Engagement with a GP at the time of enrolment and over the course of trial participation.
•8\.Consent for the research team to communicate with the participant’s clinical treatment team in regard to a) Their progress through the trial and b) Communicate clinical deterioration and risks to allow facilitation of appropriate management, where clinically\-indicated.

•1\.Inability to provide informed consent.
•2\.Hospitalisation within the 2\-months prior to screening for the purpose of managing risk of refeeding or treatment of other medical instability that has a causal link with AN.
•3\.Physical parameters meeting Criteria for Medical Ward Admission as per the The Royal Australian and New Zealand College of Psychiatrists (RANZCP) Alfred Health Eating Disorder – Inpatient Access and Treatment Pathways Guideline, namely:
•a.High refeeding risk;
•b.Vital signs as follows:
•i.Systolic BP \< 80 mmHg;
•ii.Postural BP drop \> 20 mmHg systolic, \> 10 mmHg diastolic;
•iii.Heart rate \< 40 or \> 110;
•iv.Postural tachycardia \>20bpm
•v.Temperature \< 35\.5°C.