A Six-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of GSK561679 Compared to Placebo in Female Subjects, Diagnosed With Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change From Randomization to the End of Treatment Phase (Week 6) in the Bech Melancholia Subscale (Bech) (Items 1, 2, 7, 8, 10 and 13) From the Hamilton Rating Scale for Depression (HamD17).
研究概览
简要总结
This six-week study will evaluate the efficacy, safety and tolerability of GSK561679 compared to placebo in female subjects with major depressive disorder
详细描述
This is a double-blind placebo controlled study to assess the CRF1 receptor antagonist, GSK561679, for treatment of depression in adult females diagnosed with Major Depressive Disorder (MDD). A treatment regimen of 350mg/day will be utilized to assess both efficacy and tolerability. Subjects will be randomized in equal numbers (n=75/arm) to the treatment arm and the placebo arm for a 6-week treatment period.
Efficacy will be assessed by determining the change from baseline in symptoms of MDD and anxiety utilizing the Bech Melancholia scale (Bech), Hamilton Rating Scale for Depression (HamD17), Inventory of Depressive Symptomatology-Self-Report (IDS-SR), Clinical Global Impression - Severity of Illness (CGI-S), Clinical Global Impression - Global Improvement (CGI-I), Medical Outcomes Study 12-item Sleep Module (MOS 12), Cohen Perceived Stress Test (PSS), Hamilton Anxiety Scale (HamA), and Dexamethasone Suppression Test (DST). Safety and tolerability will be assessed by determining the incidence of adverse events (AEs), vital signs, BMI, weight, clinical laboratory parameters, including ECGs, during the treatment and pre & post-treatment phases, and Discontinuation Emergent Signs and Symptoms (DESS). In addition, the incidence of suicidality will be assessed by the Columbia Suicide Severity Rating Scale (C-SSRS).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
GSK561679 arm
Double blind GSK561679
干预措施: GSK561679 (Drug)
placebo arm
Double blind placebo
干预措施: Placebo (Other)
结局指标
主要结局
Change From Randomization to the End of Treatment Phase (Week 6) in the Bech Melancholia Subscale (Bech) (Items 1, 2, 7, 8, 10 and 13) From the Hamilton Rating Scale for Depression (HamD17).
时间窗: Randomization (Week 0) and Week 6
The Bech Melancholia Sub-scale is extracted from the HAMD-17 and is comprised of the following 6 items: Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic, and Somatic Symptoms General. The items Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic are scored on a 5-point scale from 0 to 4 except for Somatic Symptoms General which is scored on a 3-point scale from 0 to 2 where the higher scores reflecting greater severity. The Bech Melancholia Scale total score is calculated by summing the individual response scores. The highest possible score is 22 (indicative of greater severity) and the lowest possible score is 0 (indicating absence of symptoms). Change from randomization was defined as the post-baseline value minus the value at randomization. Randomization was defined as Week 0.
次要结局
- Change From Randomization to Weeks 1, 2, and 4 in the Bech Melancholia Scale Score.(Randomization (Week 0) and Week 1, 2 and 4)
- Change From Randomization to Weeks 1, 2, 4, and 6 in the Hamilton Anxiety Scale (HAM A)(Randomization (Week 0) and Week 1, 2, 4 and Week 6)
- Change From Randomization to Weeks 1, 2, 4, and 6 in the Hamilton Rating Scale for Depression (HAMD-17)(Randomization (Week 0) and Week 1, 2, 4 and Week 6)
- Percentage HAMD-17 Responders at Weeks 1, 2, 4, and 6.(Weeks 1, 2, 4, and 6.)
- Time to Maintained Antidepressant Response at the End of Treatment Phase (Week 6)(Week 6)
- Change From Randomization to Weeks 1, 2, 3, 4, and 6 in the Inventory of Depressive Symptomatology-Self- Report (IDS-SR) Total Score.(Randomization (Week 0) and Week 1, 2, 3,4 and Week 6)
- Change From Randomization in the Clinical Global Impression - Severity of Illness (CGI-S) Score at Weeks 1, 2, 4, and 6.(Randomization (Week 0) and Weeks 1, 2, 4, and 6.)
- Percentage of Clinical Global Impression - Global Improvement (CGI-I) Responders at Weeks 1, 2, 4, and 6.(Weeks 1, 2, 4, and 6.)
- Change From Randomization in the Medical Outcomes Study 12-item Sleep Module (MOS 12) at Week 6(Randomization (Week 0) and Week 6)
- Change From Randomization in the Cohen Perceived Stress Scale (PSS) at Week 6.(Randomization (Week 0) and Week 6.)
- Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)(Up to 28-day FU (18 months))
- Number of Participants With Vital Sign of Potential Clinical Importance (PCI)(Up to Week 10)
- Number of Participants With Clinical Chemistry Laboratory Data Outside Reference Range(Upto Week 10)
- Number of Participants With Hormonal Data of PCI(up to Week 10)
- Discontinuation-Emergent Signs and Symptoms(At Week 6, 7-day (D) FU and 28-D FU)
- Number of Participants With Abnormal Urinalysis Data(Randomization (Week 0), Week 3, Week 6/ Early withdrawal (EW) and 28 Day follow-up (FU))
- Number of Participants With Abnormal Electrocardiograph (ECG) Values(Randomization (Week 0), Week 4, Week 6 and 28 Day follow-up)
- Number of Participants With Abnormal Hematology Values of PCI-Platelet(Upto 28-day FU)