Does Semaglutide Improve Depressive Symptoms in Patients With Major Depressive Disorder and Overweight or Obesity

Официальное название

Is the GLP-1 Receptor Agonist Semaglutide Able to Alleviate Mood in Patients With Major Depressive Disorder and Overweight or Obesity

Обзор

This 26-week long, double-blinded randomized clinical trial aims to investigate the effects of semaglutide once-weekly vs. placebo on depressive symptoms in 116 patients with Major Depressive Disorder (MDD) and co-existing overweight or obesity. The treatment will be an add-on treatment to the patient's usual medication. The investigators hypothesize that adjunctive treatment with semaglutide, will lead to a significant improvement in mood compared to placebo in patients with MDD and overweight or obesity. The primary endpoint is the change in depressive symptoms measured as difference in the 12-item self-report mood questionnaire Major Depression Inventory (MDI) from start to follow-up after 26 weeks. The MDI measures the extent to which symptoms of depression have been present in the past two weeks.

Подробное описание

This 26 week, randomized, double-blinded, placebo-controlled clinical trial investigate effects of semaglutide once-weekly vs. placebo on depressive symptoms in patients with unipolar disorder and comorbid obesity or overweight aged 18 years to 65 years. The primary endpoint is the change in depressive symptoms measured as difference in the 12-item self-report mood questionnaire Major Depression Inventory (MDI) from week 0 to week 26.

Participants will be randomized to receive once-weekly injection of either semaglutide or placebo.

Patients will be treated for 26 weeks with an initial dose of semaglutide of 0.25 mg once weekly for four weeks, 0.50 mg once weekly for four weeks 1.0 mg for four weeks, 1.7 mg for four weeks and finally 2.4 mg for the remaining treatment period. Assessments will be conducted at weeks 0, 4, 8, 12, 16, 20, 24, and 26. Adherence and adverse events will be assessed during the entire treatment period. In addition, heart rate, blood pressure, height, body weight, waist and hip circumference will be recorded. The diagnosis of depression will be confirmed at baseline and depressive symptoms will be assessed with Hamilton Depression Rating Scale (HAM-D17) at baseline week 0, 12 and 26. MDI will be completed monthly. Participants will also complete questionnaires on physical activity, cognitive complaints, perceived stress, the reward system, Quality of life, alcohol use, and sleep quality at baseline and week 26.

Вмешательства

• Препарат Semaglutide Injectable Product
  Semaglutide (Wegovy) once-weekly injection s.c
• Препарат Placebo
  Placebo (BD Posiflush) once-weekly injection s.c

Первичные конечные точки

• Change in depressive symptoms [Срок оценки: From baseline to 26 weeks of treatment]

Вторичные конечные точки (5)

• Glycaemic control parameters (blood sampling) [Срок оценки: From baseline to 26 weeks of treatment]
• Body weight [Срок оценки: From baseline to 26 weeks]
• Waist circumference [Срок оценки: From baseline to 26 weeks of treatment]
• Hamilton Depression Rating Scale, 17-items (HDRS-17) score [Срок оценки: From baseline to 26 weeks of treatment]
• Functioning assessment short test (FAST) score [Срок оценки: From baseline to 26 weeks of treatment]

Критерии участия

Критерии включения

• Informed oral and written consent.
• Diagnosed with unipolar disorder according to the criteria of ICD10 (International Classification of Diseases, World Health Organization (WHO)) or the DSM-V (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, the American Psychiatric Association
• Hamilton Depression Rating Scale, 17-items (HDRS-17)47 score ≥14,
• Age 18 years to 65 years (both included)
• Body mass index (BMI) ≥27 kg/m2
• Able to speak and understand Danish

Критерии исключения

• Any significant medical disorder or conditions that contraindicate the investigational drug, e.g., pregnancy, presence of known allergy GLP-1 receptor agonists, severe neurological disorder, on-going drug, or alcohol abuse
• Coercive measures
• Females of childbearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant within the next 9 months (26 weeks plus two months after discontinuation of semaglutide), or are not using contraceptives (during the whole study period) considered as highly effective (combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) intrauterine device - IUD, IUS, bilateral tubal occlusion, vasectomised partner, sexual abstinence)
• Patients treated with corticosteroids or other hormone therapy (except oestrogens).
• Any active substance abuse or dependence (except for nicotine)
• Impaired hepatic function (plasma liver transaminases >2 times upper normal limit).
• Impaired renal function (serum creatinine >150 μmol/l)
• Cardiac problems defined as decompensated heart failure (NYHA class III/IV), unstable angina pectoris, and/or myocardial infarction within the last 12 months
• Hypertension with systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg
• Impaired pancreatic function (acute or chronic pancreatitis and/or plasma amylase >2 times upper normal limit). Receiving any experimental or pre-marketing drug within the last 3 months
• Use of diabetes medication or weight-lowering pharmacotherapy e.g. semagultid within the preceding 3 months
• Known type 1 and 2 diabetes or HbA1c>48mmol/l
• Suicidal behaviour as judged by the investigator and based on clinical evaluation. At all contact with patient attendance (please see Table 1) possible suicidality will be evaluatedaccording to the guidelines. If the patient is evaluated as suicidal, the person will be excluded from the study and evaluated by a senior consultant in psychiatry, who will take further action.
• Any condition that the investigator feels would interfere with trial participation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Mental Health Centre North Zealand — Hillerød

Идентификаторы

NCT: NCT07136714 · 2024-511734-13-04 · 2024-511734-13-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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