Metreleptin in Anorexia Nervosa
ConditionAnorexia Nervosa
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age17-65
SponsorGabriella Milos
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Metreleptin
- Sodium chloride
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Gabriella Milos
Lead sponsor
University of Zurich
Sponsor institution
Source ClinicalTrials.gov