NCT04210973Unknown3 期
Efficacy and Safety Study of Anyu Peibo in the Treatment of Major Depressive Disorder(MDD): a Ⅲ Randomized, Double-Blind, Placebo-Paralleled, Multicenter Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 3 期
- 入组人数
- 266
- 试验地点
- 15
- 主要终点
- The change of total score from baseline in Montgomery Asberg Depression Rating Scale （MADRS）
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Anyu Peibo Capsule comparing with placebo in the treatment of Chinese Patients with 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
- 否
入选标准
- •Adult with primary diagnosis of major depressive disorder(MDD) based on the criteria of DSM-5, single episode or recurrent episode. [296.21; 296.22; 296.23; 296.31; 296.32; 296.33]
- •The total score of MADRS is ≥26 in both screening visit and baseline visit.
- •The first item of MADRS is ≥3 in both screening visit and baseline visit.
- •CGI-S is ≥4 in both screening visit and baseline visit.
- •The subject understands and consents to takes part in this clinical trials. The subjects should sign informed consent form.
排除标准
- •The subject has a current psychiatric diagnosis other than depression.
- •The subject has a suicide attempt within recent 1 year, or has a currently significant risk of suicide, or has a score ≥3 on item 10 (suicidal ideation) of MADRS.
- •The subject has a current depressive episode due to somatic general disease or a neurological disease, such as hypothyroidism.
- •When the MADRS total score of baseline visit compares with the screening visit, the decreasing rate is ≥25%.
- •Known hypersensitivity to Big Leaf Ju, or at least to two kinds of drugs.
- •Any unstable cardiovascular, hepatic, renal, blood, endocrine, or other medical disease.
- •Any neurological disease (such as Parkinson's Disease, cerebrovascular accident and epilepsy) or cerebral injury (traumatic or disease related).
- •Had a history or a high risk related disease or medication of seizure disorder, except infantile febrile convulsion.
- •The subject could not take medication or has a disease affecting drug absorption, distribution, metabolism and excretion.
- •Clinically significant electrocardiographic(ECG) abnormalities in screening visit. Such as QTc ≥450 ms in male or ≥470 ms in female.
- •Clinically significant abnormal laboratory values (eg. ALT or AST value above 2 times of clinical top-limit; Cr value above normal top-limit; thyroid gland function index (≥ 2 items in 5 items) above 1.2 times or below 0.8 times of the normal range, or investigator diagnosed with hypothyroidism or hyperthyroidism).
- •The subject who used at least two different antidepressants with recommended dose and adequate duration (maximum dosage by at least 4 weeks according to label) treatment still had no respond.
- •The subject uses antidepressant drug normally before 2 weeks of screening, and stops using psychotropic drug before randomization less than 5 half-life period (monoamine oxidase inhibitor: at least 2 weeks; fluoxetine: at least 1 month).
- •The subject received systematic light therapy, laser therapy and acupuncture or other Traditional Chinese Medicine, or systemic biofeedback therap within 2 weeks.
- •The subject received modified ECT, trans-cranial magnetic stimulation (TMS), vagus nerve stimulation (VNS) or systematic psychotherapy within 3 months.
- •Women who were pregnant, breast-feeding, or serum-HCG(+) on screening; or planning to become pregnant within 3 months after kick-off of clinical trial.
- •Education level below junior high school.
- •The subject has participated in a drug clinical trial within 1 month before screening.
- •The investigator thinks the subject is unsuitable to enroll in this clinical trial.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo,oral, twice per day
干预措施: Placebo (Drug)
Anyu Peibo
Experimental
Anyu Peibo Capsule, oral, 0.8g twice per day
干预措施: Anyu Peibo (Drug)
结局指标
主要结局
The change of total score from baseline in Montgomery Asberg Depression Rating Scale （MADRS）
时间窗: 8 weeks
the minimum and maximum values of MADRS are from 0 to 60, and higher scores mean a worse outcome
次要结局
- Proportion of subjects who combined medication to treat insomnia(8 weeks)
- Heartbeat Rate(8 weeks)
- The change of total score of MADRS by time(8 weeks)
- The change of total score from baseline in HAMD17(8 weeks)
- The change of total score from baseline in Hamilton Anxiety Scale (HAMA)(8 weeks)
- Clinical Global Impression-Severity of Illness (CGI-I) score(8 weeks)
- The change of total score from baseline in Discriminative Scale Space Tracker (DSST)(8 weeks)
- Clinical Remission Rate according to total score of MADRS at the end of study(8 weeks)
- Breath Rate(8 weeks)
- Clinical Remission Rate according to 17-items Hamilton Depression Scale (HAMD17) total score at the end of study(8 weeks)
- The change of score from baseline in Clinical Global Impression-Severity of Illness (CGI-S)(8 weeks)
- The change of total score from baseline in Trail Making Test (TMT) A&B(8 weeks)
- The change of total score from baseline in Sheehan Disability Scale (SDS)(8 weeks)
- Electrocardiogram(ECG)(8 weeks)
- Proportion of subjects who withdrew from clinical trial due to poor efficacy(8 weeks)
- Pulse Rate(8 weeks)
- Systolic blood pressure(8 weeks)
- Assessment of Arizona Sexual Experience Scale (ASES)(8 weeks)
- Incidence rate of AE(8 weeks)
- Diastolic blood pressure(8 weeks)
- Number of Participants with AE result in early withdrawal from clinical trials(8 weeks)
- Number of Participants with Serious Adverse Event (SAE) result in early withdrawal from clinical trials(8 weeks)
- Number of Emerging AE during drug withdrawal period(9 weeks)
研究者
研究点 (15)
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