A Clinical Trial of Fluvoxamine for Melancholia
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Hamilton Depression Rating Scale-17 item (HAMD-17)
研究概览
简要总结
This study aims at investigating the special effectiveness of antidepressant effect of Fluvoxamine for endogenous depression. The investigators also aim to assess the effect of Fluvoxamine on the multimodal magnetic resonance imaging(MRI), blood cytokines, feces bacteria flora and neuropsychological performance in depression patients with melancholic features. The investigators further aim to identify the predictors of Fluvoxamine's antidepressant effeect using the above techniques.
详细描述
This study aims at investigating the special effectiveness of antidepressant effect of Fluvoxamine for melancholia. The investigators also aim to assess the effect of Fluvoxamine on the multimodal magnetic resonance imaging(MRI), blood cytokines, feces bacteria flora and neuropsychological performance in depression patients with melancholic features. The investigators further aim to identify the predictors of Fluvoxamine's antidepressant effeect using the above techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult (18-55 years, both sexes), with DSM-4 criteria for MDD without psychosis, as determined by a structured clinical interview Mini International Neuropsychiatric Interview
- •Moderate to severe depression, as defined by a pretreatment score ≥17 on the HDRS-17 scale
- •Informed consent to participate in this study
- •ethinic Han, right-handed, Junior high school education or above
排除标准
- •A history of bipolar disorder, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, panic disorder, or documented Axis II diagnoses; active suicidal intention, as determined by clinical interview
- •Active or recent (<12 months) substance abuse or dependence; excluding nicotine
- •Presence of ECT treatment in recent 6 months
- •period of pregnancy or lactation
- •hearing disorder or colour blindness
- •Immediate relatives have bipolar disorder or mania disorder
研究组 & 干预措施
melancholic depression
patients with melancholic depression undergo the treatment of Fluvoxamine
干预措施: Fluvoxamine (Drug)
non-melancholic depression
patients with non-melancholic depression undergo the treatment of Fluvoxamine
干预措施: Fluvoxamine (Drug)
结局指标
主要结局
Change in Hamilton Depression Rating Scale-17 item (HAMD-17)
时间窗: Baseline, 2weeks, 1 months, 2 months
Interview-based questionnaire used to measure the severity of depression. Consists of 17 items with a score calculated. Higher scores are associated with more severe depression.
Change in voxel-based morphometry of grey matter, white matter as assessed by structural magnetic resonancce imaging
时间窗: Baseline, 2 months
Participants will receive resting-state functional magnetic resonance imaging (MRI). Scans will be performed on a 3.0- T Siemens Magnetom Skyra scanner (Siemens Healthineers, Erlangen, Germany). During scanning, all participants were instructed to remain motionless, and to think of nothing in particular but to not fall asleep.
Change in Functional connectivity
时间窗: Baseline, 2 months
Change in Functional connectivity of the brain networks as assessed by measure of connectivity in multimodal MRI.
Change in Hamilton Anxiety Rating Scale-14 item (HAMA-14)
时间窗: Baseline, 1 months, 2 months
Interview-based questionnaire used to measure the severity of anxiety. Consists of 14 items with a score calculated. Higher scores are associated with more severe anxiety.
次要结局
- Change in peripheral blood cytokines(Baseline, 1 months, 2 months)
- Change in feces bacterial flora(Baseline, 1 months, 2 months)
- Hopkins Vocabulary Learning Test-Revised (HVLT-R)(Baseline, 1 months, 2 months)
- Generalized Anxiety Disoder-7 (GAD-7)(Baseline, 1 months, 2 months)
- Sheehan Disability Scale (SDS)(Baseline, 1 months, 2 months)
- Self-reported Quick Inventory of Depressive Symptomatology (QIDS-SR) Scale(Baseline, 1 months, 2 months)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline, 1 months, 2 months)
- Perceived Deficit Questionnaire for Depression (PDQ-D)(Baseline, 1 months, 2 months)
- Change in Congruent STROOP Time to Complete (Executive Function)(Baseline, 1 months, 2 months)
- Change in DSST (Number of Correct Symbols)(Baseline, 1 months, 2 months)
- Improvement on Snaith-Hamilton Pleasure Scale (SHAPS)(Baseline, 1 months, 2 months)
- Life Event Scale (LES)(Baseline, 1 months, 2 months)
- Sydney Melancholia Prototype Index (SMPI)(Baseline, 1 months, 2 months)
- Young Manic Rating Scale (YMSR)(Baseline, 1 months, 2 months)
- Dimensional Anhedonia Rating Scale (DARS)(Baseline, 1 months, 2 months)
- Child Trauma Scale (CTQ)(Baseline, 1 months, 2 months)
- Rating Scale for Side Effects (SERS)(1 months, 2 months)
- Beck Scale for Suicide Ideation（BSI）(Baseline, 1 months, 2 months)
- Medication Adherence Rating Scale (MARS)(1 months, 2 months)
研究者
Lingjiang Li
President of Chinese Psychiatry Society of Chinese Medical
Central South University