JPRN-jRCT2080222363已完成3 期
A Multicenter, Randomized, Double-blind Trial to Assess the Efficacy and Safety of ASC-01 in Patients with Major Depressive Disorder
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 412
研究概览
简要总结
The results of this trial verify the efficacy and confirm the safety of ASC-01 in patients with MDD who have responded incompletely to sertraline monotherapy.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 64age old（—）
- 性别
- All
入选标准
- •1) Patients who are either inpatients or outpatients.
- •2) Patients who are able to understand necessary information for giving consent to undergo examinations, observations, and evaluations specified in this clinical protocol, and who are able to give written consent based on a full understanding of the trial.
- •3)Patients who have been given a diagnosis of Major Depressive Disorder, Single Episode or Major Depressive Disorder, Recurrent according to the DSM-5 and who have a current episode of major depression that has been continuing for at least 8 weeks
- •4) Patients with a HAM-D17 total score of 18 or more at the Screening Period evaluation
排除标准
- •1) Female patients of childbearing potential who wish to become pregnant during the trial period or within 4 weeks after completion or discontinuation of the trial
- •2) Pregnant or breast-feeding female patients, or female patients who may be pregnant
- •3) Patients judged to be intolerant to all antidepressant (including drugs not used for their current episodes of major depression) based on their treatment history
- •4) Patients who have had electroconvulsive therapy
- •5) Patients who have enrolled in a clinical trial of other drugs or medical devices within 1 month before the time of informed consent
- •6) Patients who have a medical history suggesting a risk of developing serious adverse events or symptoms that may hinder efficacy/safety evaluation (eg, symptoms of fibromyalgia, or premenstrual syndrome etc that overlap with depressive symptoms)
- •7) Patients with complications or a history of diabetes mellitus, or patients who have been judged to be diabetic i) fasting blood glucose level equal to or more than 126 mg/dL, ii) 2-hour glucose level in 75-g oral glucose tolerance test (OGTT) equal to or more than 200 mg/dL, iii) non-fasting blood glucose level equal to or more than 200 mg/dL, or iv) HbA1c [NGSP level] equal to or more than 6.5%)
- •8) Patients who are undergoing treatment for thyroid disease (except for patients whose disease has been stabilized with drug therapy for 3 months or longer before the time of informed consent)
- •9) Patients who have a history of neuroleptic malignant syndrome or serotonin syndrome
- •10) Patients who have a history of seizure disorder (eg, epilepsy)
研究者
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