ACTRN12621000601831已完成4 期
Agomelatine in Depression: An Exploratory Open Label Study of the Neurobiological Effects of Agomelatine in Adults with Major Depressive Disorder
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 29
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 74 Years（—）
- 性别
- All
入选标准
- •1.Age/Sex:
- •Male or female, aged 18 to <75 years old at the time of informed consent.
- •2.Diagnosis
- •Major Depressive Disorder (MDD)
- •3.Severity
- •Moderate or severe depression based on the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) depression criteria.
- •4.Treatment history
- •Currently on an antidepressant
- •5.Biomarkers
- •Agrees to, and is eligible for all biomarker assessments
- •Fluent in English
- •Ability to provide informed consent and complete all assessments independently.
排除标准
- •Aged 75 or older at the time of informed consent
- •2. Treatment
- •Concurrent use of potent CYP1A2 inhibitors (e.g. fluvoxamine and ciprofloxacin)
- •3. Medical Conditions:
- •Hepatic impairment (i.e. cirrhosis or active liver disease)
- •Baseline serum transaminase levels exceed 3 times the upper limit of normal
- •Pregnant or breastfeeding. If female, must be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) or must agree to use two clinically acceptable methods of contraception (e.g., oral, intrauterine device [IUD; diaphragm], injectable, transdermal or implantable contraception) or abstinence during the study, and for as long as they remain on sponsor provided agomelatine treatment.
- •Severe impediment to vision, hearing, comprehension, and/or hand movement that interferes with study tasks
- •Concurrent or recent participation in any another research study aimed at treating mental illness.
研究者
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