Metreleptin in Anorexia Nervosa, Randomized Controlled Trial; Effects on Depressive Symptoms and Concomitant Changes in Brain Connectivity

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The treatment of anorexia nervosa often proves to be difficult. There are no drugs that work specifically for the treatment of anorexia nervosa. Experimental administration of metreleptin (synthetically produced leptin) to patients with anorexia nervosa has produced positive results. This study tests the effect of metreleptin in comparison with placebo, which could potentially make treatment easier. The aim of the study is to investigate whether treatment with metreleptin can help to reduce the symptoms of anorexia nervosa and improve mood and weight.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 17
Maximum Age: 65
Healthy Volunteers: f
View:

• 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 pregnancy test, non-lactating and double birth control

• Informed Consent as documented by signature

Locations
Other Locations
Switzerland
Eating Disorder Unit, Clinic of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich
RECRUITING
Zurich
Contact Information
Primary
Gabriella Milos, Prof. Dr. med.
Gabriella.Milos@usz.ch
0041 44 255 52 80
Backup
Lisa Guth, MSc Psychology
Lisa.Guth@usz.ch
0041 44 255 97 17
Time Frame
Start Date: 2024-05-31
Estimated Completion Date: 2026-08-30
Participants
Target number of participants: 50
Treatments
Experimental: Metreleptin-assisted therapy
25 patients will receive a daily subcutaneous injection of metreleptin for 14 days.~The dose starts with 0.4 ml daily, and gradually increases until 1.8 ml; until 1.2 ml in male patients daily.
Placebo_comparator: Placebo-therapy
25 patients will receive a daily subcutaneous injection of inactive substance (placebo) for 14 days. To ensure blinding, the dosing scheme of placebo will have the identical volume to the dosing scheme of metreleptin (verum).
Related Therapeutic Areas
Sponsors
Leads: Gabriella Milos

This content was sourced from clinicaltrials.gov