Phase 2 Study of FK949E - Double-blind, Placebo-controlled, Comparative Study in Major Depressive Disorder Patients With Inadequate Response to Existing Antidepressants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 172
- 主要终点
- Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
研究概览
简要总结
In this study, quetiapine XR or placebo will be administered orally for 6 weeks to major depressive disorder patients with lack of response to existing antidepressants, with the aim of evaluating the efficacy of quetiapine XR and dose-response in three quetiapine XR dose groups based on changes in Montgomery-Asberg Depression Rating Scale (MADRS) scores.
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
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of major depressive disorder as specified in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) with the use of the Mini-International Neuropsychiatric Interview (M.I.N.I.)
- •Documented appropriate treatment history (i.e., lack of response to treatment at labeled dosage for at least 4 weeks) for the current major depression episode with an antidepressant other than that used concomitantly with the study drug
- •The Hamilton Depression Rating Scale (HAM-D17) total score of 20 points or more and HAM-D17 depressed mood score of 2 points or more
排除标准
- •Concurrent or previous history of DSM-IV-TR Axis I disorders, except major depressive disorder, within the last 6 months before informed consent
- •Concurrence of DSM-IV-TR Axis II disorder that is considered to greatly affect patient's current mental status
- •The duration of the current major depression episode is shorter than 4 weeks or longer than 24 months at informed consent
- •History of dependence of substances other than caffeine and nicotine or history of abuse or dependence of alcohol
- •The HAM-D17 suicide score of 3 points or more, history of suicide attempt within the last 6 months before informed consent, or the risk of suicide in the investigator's or subinvestigator's opinion
- •Concurrent or previous history of diabetes mellitus. HbA1c levels of 6.1% (Japan Diabetes Society values) or more within the past 2 months
- •Electroconvulsive therapy within the last 62 days before primary registration (within the last 90 days before secondary registration)
- •Treatment with a depot antipsychotic within the last 28 days
- •Documented or suspected (to be a carrier of) conditions such as renal failure, hepatic failure, serious cardiac disease (or current use of antiarrhythmic drugs), hepatitis B, hepatitis C, or acquired immunodeficiency syndrome (AIDS)
- •Concurrence of uncontrolled hypertension (defined as a systolic blood pressure of 180 mmHg or more, or a diastolic blood pressure of 110 mmHg or more at primary registration) or unstable angina that may worsen with the study or may affect the study results based on the clinical judgment of the investigator or subinvestigator
- •Concurrence of hypotension (defined as a systolic blood pressure of less than 100 mmHg at primary registration) or orthostatic hypotension
- •Concurrence of malabsorption syndrome, hepatic disease, or other conditions that may affect the absorption and/or metabolism of the study drug
- •Concurrent or previous history of cerebrovascular disease or transient ischemic attack (TIA)
- •Known hypersensitivity to quetiapine or any component of FK949E tablets
研究组 & 干预措施
Placebo
Participants received matching placebo tablets once daily before bedtime for 7 weeks.
干预措施: Placebo (Drug)
Quetiapine 50 mg
Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
干预措施: quetiapine extended release (XR) (Drug)
Quetiapine 150 mg
After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
干预措施: quetiapine extended release (XR) (Drug)
Quetiapine 300 mg
After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
干预措施: quetiapine extended release (XR) (Drug)
结局指标
主要结局
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
时间窗: Baseline and Week 6
The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.
次要结局
- Change From Baseline in Hamilton Rating Score for Depression (HAM-D17)(Baseline and Week 6)
- Percentage of Participants With Improvement in Clinical Global Impressions-Improvement (CGI-I)(Baseline and Week 6)
- Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)(Baseline and Week 6)
- Change From Baseline in Pittsburgh Sleep Quality Index (PSQI)(Baseline and Week 6)
- Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests(Up to 8 weeks)