HumRes64897
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SNCTP000005791
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BASEC2022-01328
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NCT06305182
Use of Metreleptin in Anorexia
Zusammenfassung der Studie
The hormone leptin is primarily produced by fat cells in our body. In the human body, the hormone leptin plays an essential role in adapting the organism to the state of hunger. If a person eats too little for an extended period, it leads to weight loss and a reduction in fat mass. Consequently, the leptin level in the blood also decreases. If the level falls below a certain threshold, numerous functions in the brain and throughout the body are affected, aiming to adjust the organism to the state of hunger. To survive, the body then conserves energy wherever possible. This includes, for example, the cessation of menstruation in women, lowering body temperature, and reducing pulse and blood pressure. There is clear evidence from animal experiments that psychological functions can also change due to the drop in leptin levels. For example, physical activity may significantly increase in a state of hunger, or depression may manifest. Positive effects have already been observed in some patients with anorexia treated with Metreleptin. Therefore, we wish to investigate the effect of Metreleptin in a larger number of patients with anorexia in this study. To control potential influencing factors, half of the participants will receive Metreleptin, and the other half will receive an inactive substance (placebo).
(BASEC)
Untersuchte Intervention
Interventions:
• 25 patients will receive a subcutaneous injection (under the skin) of Metreleptin daily for 14 days.
• 25 patients will receive a subcutaneous injection of an inactive substance (placebo) daily for 14 days.
The main objective of the study is to examine the effects of Metreleptin - compared to placebo - on depression and body weight in patients with anorexia. Furthermore, we want to examine the direct effect of Metreleptin on the symptoms of anorexia (e.g., constant thoughts about food, fear of weight gain, urge to move). We also want to investigate how Metreleptin affects the brain.
Participants will be examined through interviews and questionnaires. During the study, medical examinations and blood draws will also be conducted to monitor body functions and to examine the effect of Metreleptin on various organ systems. Additionally, we will perform brain imaging studies (MRI). The examinations will take place before, during, and 5 weeks after treatment.
(BASEC)
Untersuchte Krankheit(en)
Anorexia is a condition that can have many negative psychological and physical effects on life and can lead to life-threatening conditions. It is typical that those affected do not feel ill, have a distorted body image, and have a pathological desire to continue reducing their body weight. This disease typically affects young people, predominantly young women. The treatment of anorexia often proves to be very difficult, and there are no medications that specifically act to cure this disease. With this research project, we aim to find out whether treatment with Metreleptin - artificially produced leptin - can help reduce the symptoms of anorexia and improve mood.
(BASEC)
Kriterien zur Teilnahme
Main inclusion criteria: • Diagnosis of anorexia • BMI > 13 kg/m2; BMI < 18 kg/m2; Weight > 35 kg • Hospitalization at the Eating Disorder Center, Consultative Psychiatry and Psychosomatics Clinic, University Hospital Zurich • Age between 17 - 65 years • Stable physical condition (BASEC)
Ausschlusskriterien
Main exclusion criteria • Current substance dependence • Severe psychological and/or physical illness: e.g., schizophrenia, inflammatory bowel disease, diabetes, autoimmune diseases, tumors • Acute suicidality, current severe self-harming behavior (BASEC)
Main inclusion criteria: • Diagnosis of anorexia • BMI > 13 kg/m2; BMI < 18 kg/m2; Weight > 35 kg • Hospitalization at the Eating Disorder Center, Consultative Psychiatry and Psychosomatics Clinic, University Hospital Zurich • Age between 17 - 65 years • Stable physical condition (BASEC)
Ausschlusskriterien
Main exclusion criteria • Current substance dependence • Severe psychological and/or physical illness: e.g., schizophrenia, inflammatory bowel disease, diabetes, autoimmune diseases, tumors • Acute suicidality, current severe self-harming behavior (BASEC)
Studienstandort
Zürich
(BASEC)
Switzerland (ICTRP)
Sponsor
Gabriella Milos
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Gabriella Milos
+4179 482 22 04
gabriella.milos@clutterusz.chKlinik für Konsiliarpsychiatrie und Psychosomatik, Universitäts Spital Zürich, Haldenbachstr. 16/18, 8091 Zürich
(BASEC)
Wissenschaftliche Auskünfte
0041 44 255 52 80;+41 44 255 52 51
gabriella.milos@clutterusz.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
13.12.2022
(BASEC)
ICTRP Studien-ID
NCT06305182 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
METRELEPTIN IN ANOREXIA NERVOSA, RANDOMIZED CONTROLLED TRIAL; EFFECTS ON DEPRESSIVE SYMPTOMS AND CONCOMITANT CHANGES IN BRAIN CONNECTIVITY (BASEC)
Wissenschaftlicher Titel
Metreleptin in Anorexia Nervosa, Randomized Controlled Trial Effects on Depressive Symptoms and Concomitant Changes in Brain Connectivity (ICTRP)
Öffentlicher Titel
Metreleptin in Anorexia Nervosa (ICTRP)
Untersuchte Krankheit(en)
Anorexia Nervosa (ICTRP)
Untersuchte Intervention
Drug: MetreleptinDrug: Sodium chloride (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
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 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 (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Clinician-rated depression on the 17 point Hamilton Depression Scale (HAMD-17) in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Body weight status in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up (ICTRP)
Subjective depression by the Beck Depression Inventory-II (BDI-II) in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Functional brain connectivity in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Anorexia Nervosa psychopathology assessed by the Eating Disorders Examination Questionnaire (EDE-Q) in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;External rated hyperkinesia assessed by the Structured Inventory for Anorexic and Bulimic Eating Disorders (SIAB, item 42) in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Subjective hyperkinesia assessed by the Exercise and Eating Disorders Questionnaire (EED) in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Autism symptoms assessed by the Autism-Spectrum Quotient-short version (AQ-k) in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Patient's quality of life by items 1, 2, 5, 6, 7, 10, 17, 19, 20, and 22 from the WHO Quality of Life Questionnaire (WHOQOL-BREF) in the metreleptin-assisted therapy group compared to placebo-therapy between Baseline, Post Treatment and 5 weeks Follow Up;Visual Analog Scale (VAS) about key Anorexia Nervosa and depression symptoms in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Social interaction by the Liebowitz Social Anxiety Scale (LSAS) in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Anhedonia by the Snaith-Hamilton Pleasure Scale (SHAPS-D) in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Hematology in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Hematology in the metreleptin-assisted therapy group compared to placebo-therapy group between;Hematology in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Hematology in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Hematology in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Blood chemistry 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weeks Follow Up;Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up;Heart Frequency Variation (HFV) in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Gabriella Milos, Prof. Dr. med.;Florian Remund, MSc. Business Administration, Gabriella.Milos@usz.ch; Florian.Remund@usz.ch, 0041 44 255 52 80;+41 44 255 52 51 (ICTRP)
Sekundäre IDs
BASEC 2022-01328 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06305182 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar