Agomelatine Augmentation in Early-Nonresponsive Patients With Major Depressive Disorder Receiving SSRIs or SNRIs: a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- Side Effect Rating Scale (SERS) scores
研究概览
简要总结
The purpose of this study was to investigate the efficacy and safety of antidepressant augmentation with agomelatine in the treatment of patients with depression who did not demonstrate satisfying response to selective serotonin reuptake inhibitor (SSRI) and serotonin-noradrenaline reuptake inhibitor (SNRI) during their early phase of treatment; this study also aims to explore the effects of augmenting antidepressant treatment with agomelatine on various aspects, including sleep quality, quality of life, social functioning, and cognitive function in patients with MDD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Meeting criteria for other psychiatric disorders according to DSM-IV (except generalized anxiety disorder), such as schizophrenia, bipolar disorder, or mental disorders related to alcohol and drug dependence.
- •Current or previous history of brain organic diseases or loss of consciousness for more than 5 minutes.
- •Current or previous history of major physical diseases (including rheumatic immune system diseases, endocrine and metabolic diseases, nervous system diseases, etc.).
- •Current serious suicidal ideation or suicide attempt.
- •Pregnancy or lactation in women.
- •Color blindness (which would hinder neurocognitive testing).
- •Use of anticoagulants (e.g., heparin, warfarin), glucocorticoids, or treatment for thyroid diseases in the past 3 months.
- •Having received any neurocognitive assessment similar to this study in the past 12 months.
- •Positive urine drug screening results or abnormal thyroid function test.
- •Liver function tests showing transaminase (ALT and AST) levels 2 times above the upper limit of the normal range.
- •Electrocardiogram examination revealing a QTc ≥ 430 ms in males or QTc ≥ 450 ms in females.
研究组 & 干预措施
Experience group
In this group,participants take agomelatine at a dose of 25-50 mg/d for 8 weeks.
干预措施: Agomelatine (Drug)
Contral group
In this group,participants take a placebo at a dose of 25-50 mg/d for 8 weeks.
干预措施: Placebos (Drug)
结局指标
主要结局
Side Effect Rating Scale (SERS) scores
时间窗: Baseline (week 0), week 2, week 4, week 8
Safety: frequency and severity of adverse events; higher scores mean a better outcome.
Hamilton Depression Scale scores
时间窗: Baseline (week 0), week 2, week 4, week 8
Depression severity; higher scores mean a worse outcome.
次要结局
- Quality of life (EQ-5D-3L) scores(Baseline (week 0), week 2, week 4, week 8)
- performance of Neurocognitive test, including executive function, attention, processing speed, and memory(Baseline (week 0), week 2, week 4, week 8)
- Hamilton Anxiety Rating Scale (HAMA) scores(Baseline (week 0), week 2, week 4, week 8)
- General Anxiety Disorder-7 (GAD-7) scores(Baseline (week 0), week 2, week 4, week 8)
- Changes in Clinical Global Impression (CGI) scores(Baseline (week 0), week 2, week 4, week 8)
- Patient Health Questionnaire (PHQ-9) scores(Baseline (week 0), week 2, week 4, week 8)
- Athens Insomnia Scale (AIS) scores(Baseline (week 0), week 2, week 4, week 8)
- Snaith-Hamilton Pleasure Scale (SHAPS) scores(Baseline (week 0), week 2, week 4, week 8)
- Sheehan Disability Scale (SDS) scores(Baseline (week 0), week 2, week 4, week 8)
研究者
Lingjiang Li
President of Chinese Psychiatry Society of Chinese Medical Association
Central South University