Fluoxetine Combined With ATP Rapidly Improves Moderate to Severe Depression: a Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Hamilton Depression Scale
研究概览
简要总结
The clinical study is a randomized (1:1:1), double-blind, placebo-controlled clinical study. Recruit patients with moderate to severe depression. After signing the informed consent, patients who meet the inclusion criteria will be randomly assigned to the ATP group (fluoxetine combined with ATP) or phosphocreatine group (fluoxetine combined with phosphocreatine) or control group (fluoxetine combined with 0.9% sodium chloride) to received treatment. Then accessed scale, cognitive function and brain function before treatment and at one, two, and four weeks after treatment to initially explore the safety and efficacy of ATP combined with fluoxetine to rapidly improves moderate to severe depression.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meet DSM-V diagnostic criteria for moderate to severe depression.
- •HAMD-24 scores ≥
- •18-65 female or male.
- •Subjects who have not used any antipsychotic drugs, antidepressants, mood stabilizers (sodium valproate, lithium carbonate) or fluoxetine treatment within the first month prior to the start of this study
- •Written informed consent.
排除标准
- •Sufferring from various major mental disorders other than depression (such as bipolar disorder, schizophrenia, personality split, etc.).
- •Individuals with neurological disorders such as dementia.
- •Individuals with a high risk of suicide.
- •Pregnant and lactating women.
- •Individuals with alcohol or drug abuse or dependence within one year prior to the start of this study.
- •Contraindications to MRI.
- •Physician evaluation was not suitable for participants in this study.
结局指标
主要结局
Hamilton Depression Scale
时间窗: Baseline and one, two, four weeks after treatment
Changes in Hamilton Depression Scale（HAMD-24）
次要结局
- Stroop task(Baseline and two and four weeks after treatment)
- Hamilton Anxiety Scale(Baseline and one, two, four weeks after treatment)
- Snaith-Hamilton Pleasure Scale(Baseline and one, two, four weeks after treatment)
- Insomnia Severity Index(Baseline and one, two, four weeks after treatment)
- Patient Health Questionnaire(Baseline and one, two, four weeks after treatment)
- structural brain networks(Baseline and two, four weeks after treatment)
- functional brain networks(Baseline and two and four weeks after treatment)
- Columbia-Suicide Severity Rating Scale(Baseline and one, two, four weeks after treatment)
- Antidepressants Side Effects(Baseline and one, two, four weeks after treatment)
- interleukin- 6(Baseline and two and four weeks after treatment)
- N-back task(Baseline and two and four weeks after treatment)
- Psychomotor vigilance task(Baseline and two and four weeks after treatment)
- Clinical Global Impression(Baseline and one, two, four weeks after treatment)
- C-reaction protein(Baseline and two and four weeks after treatment)
- Tumor Necrosis Factor α(Baseline and two and four weeks after treatment)
- Attention network test(Baseline and two and four weeks after treatment)