Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06305182
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-02-06
Brief Title:
Metreleptin in Anorexia Nervosa
Sponsor:
Gabriella Milos
Organization:
University of Zurich
Study Overview
Official Title:
Metreleptin in Anorexia Nervosa Randomized Controlled Trial Effects on Depressive Symptoms and Concomitant Changes in Brain Connectivity
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
METRAN
Brief 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
Detailed Description:
Anorexia nervosa AN mainly affects young people especially young women AN is one of the most lethal psychiatric disorders Treatment often proves to be very difficult and AN course is frequently chronic Specific pharmacological therapies for AN are lacking Recent studies have shown that metabolic alterations play a great role in the etiology and pathogenesis of AN An important metabolic alteration playing a role in the etiology and pathogenesis of AN is the hormone leptin Patients with AN show hypoleptinemia The role of hypoleptinemia in the neuroendocrine adaptation to starvation seems to induce emotional cognitive and behavioral symptoms of AN From a theoretical point of view pharmacotherapy augmenting leptin levels in patients with AN have a great therapeutic potential Recently positive effects with experimental administration of subcutaneous metreleptin in few young patients with severe AN have been observed Importantly no side effects have been observed For all these reasons the present study will investigate - with a double blind design - the therapeutic effect of metreleptin in patients with AN Metreleptin will be administrated to 50 AN-inpatients 25 patients will receive verum and 25 will receive placebo during 14 days Primary objectives of this study are the amelioration of mood and weight Secondary objectives are the investigation of functional brain connectivity AN symptoms as well as hematologic blood chemistry and neuroendocrinological hormones
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None