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Recruiting NCT06305182

Metreleptin in Anorexia Nervosa

Conditions: Anorexia Nervosa

Sex: All
Ages: 17 Years – 65 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 50
Sponsor: Gabriella Milos

Location: Eating Disorder Unit, Clinic of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich Zurich Canton of Zurich

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 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06305182). StuddyBuddy aggregates publicly available trial information.