METRANMetreleptin in Anorexia Nervosa, Randomized Controlled Trial; Effects on Depressive Symptoms and Concomitant Changes in Brain Connectivity
Sodium chloride
Anorexia Nervosa+8
+ Feeding and Eating Disorders
+ Behavior
Treatment Study
Summary
Study start date: May 31, 2024
Actual date on which the first participant was enrolled.This study focuses on exploring the effects of a medication called metreleptin on individuals with anorexia nervosa, a serious eating disorder that mostly affects young women. Anorexia nervosa is not only challenging to treat but also among the most deadly psychiatric disorders. Current treatments are limited, and there is a need for new approaches. Recent research suggests that a hormone called leptin, which is often low in people with anorexia, might play a significant role in the condition. Increasing leptin levels may help to improve symptoms. This study aims to see if metreleptin can improve mood and weight in patients with anorexia nervosa, and also to understand how it affects brain function and other health measures. Participants in this study, who are patients with anorexia nervosa, will receive metreleptin or a placebo, which is a substance with no active medication, via an injection under the skin for 14 days. The study is designed so that neither the participants nor the researchers know who is receiving metreleptin and who is receiving the placebo. This helps ensure unbiased results. The main focus is to observe any improvements in mood and weight. Additionally, the study will examine how metreleptin affects the connections in the brain, symptoms of anorexia, and various blood markers. Early tests have shown metreleptin to be safe with no side effects, offering hope that it could become a useful treatment for anorexia nervosa if proven effective.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 17 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Main key inclusion criteria: * Current diagnosis of AN according to fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) confirmed with Structured Clinical Interview for DSM-5 (SCID-5) * BMI \> 13 kg/m2; BMI ≤ 18 kg/m2; body weight ≥ 35 kg * Hospitalisation in the Eating Disorders Unit, Department of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital of Zurich * Ability to understand German language * Age range: 17 - 65 years * Depressive symptoms: HAMD-17 ≥ 8 * Negative urine pregnancy test, non-lactating and double birth control * Informed Consent as documented by signature Main key exclusion criteria: * Illicit drug intake within last month; current alcohol use disorder * Severe psychiatric and/or severe somatic comorbidities; f. e. lifetime diagnosis of schizophrenia, bipolar disorder, inflammatory bowel disorders, diabetes mellitus, autoimmune disorders, pancreatitis, neurological disorders, cancer including lymphoma * Acute suicidality or current serious non-suicidal self-injury
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
100% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Eating Disorder Unit, Clinic of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich
Zurich, SwitzerlandOpen Eating Disorder Unit, Clinic of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich in Google Maps