2024-511734-13-04招募中Phase III and phase IV (Integrated)
Is the glucagon-like peptide-1 receptor agonist semaglutide able to alleviate mood in patients with major depressive disorder and overweight or obesity? Sema-Mood.
Psykiatrisk Center Nordsjaelland1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年5月7日最近更新:
试验速览
- 阶段
- Phase III and phase IV (Integrated)
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The primary outcome will be change in Major Depression Inventory from baseline to end of study
研究概览
简要总结
Primary outcome. The primary endpoint is the change in depressive symptoms measured as the difference in the 12-item self-report mood questionnaire Major Depression Inventory (MDI)48 from week 0 to week 26. MDI estimates depression symptom severity and the patients will rate how much time in the past two weeks each of the symptoms of the depressive syndrome is present
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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 ≥13,
- •Age 18 years to 70 years (both included)
- •Body mass index (BMI) ≥27 kg/m2
排除标准
- •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, diabetes I, on-going drug, or alcohol abuse
- •Coercive measures
- •Females of child-bearing potential who are pregnant, breastfeeding, or have the intention of becoming pregnant
- •Women who are not willing to use an adequate contraceptive during the full length of the study
- •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)
- •Impaired pancreatic function (acute or chronic pancreatitis and/or plasma amylase >2 times upper normal limit)
- •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 within the preceding 3 months
- •Known type 1 and 2 diabetes or HbA1c>48mmol/mol
- •No glucose-lowering medication is allowed for the trial
- •Suicidal behaviour as judged by the investigator and based on clinical evaluation. At all contact with patient attendance (except DXA scanning visits, please see Table 1) possible suicidality will be evaluated according 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
结局指标
主要结局
The primary outcome will be change in Major Depression Inventory from baseline to end of study
The primary outcome will be change in Major Depression Inventory from baseline to end of study
次要结局
- Secondary outcomes include changes in body weight, hip and waist circumference, hemoglobin A1c lean and fat body mass and bone density, biomarkers related to inflammation, and oxidative stress and further overall functioning, quality of life, perceived stress, and cognitive scores
研究者
Vinberg Maj
Scientific
Psykiatrisk Center Nordsjaelland
研究点 (1)
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