A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 34
- 主要终点
- Change From Baseline to Week 5 in the HAMD-17 Total Score
研究概览
简要总结
To assess the efficacy of pimavanserin compared to placebo when given adjunctively to a selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant as treatment of patients with Major Depressive Disorder (MDD) and an inadequate response to antidepressant therapy
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, aged 18 years and above
- •A clinical diagnosis of major depressive disorder (MDD)
- •Is being treated with one of the following SSRI or SNRI antidepressants as monotherapy:
- •Citalopram
- •Escitalopram
- •Paroxetine
- •Fluoxetine
- •Sertraline
- •Duloxetine
- •Venlafaxine
- •Desvenlafaxine
- •Venlafaxine XR
- •Has a history of inadequate response to antidepressant treatments
排除标准
- •Patient has a psychotic disorder other than MDD
- •Patient has current evidence of a serious and/or unstable neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the program
- •Patient has a history or symptoms of long QT syndrome
- •Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
研究组 & 干预措施
Pimavanserin 34 mg + SSRI/SNRI
Drug- pimavanserin, 34 mg, taken as two 17 mg tablets, once daily by mouth All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study.
干预措施: Pimavanserin (Drug)
Placebo + SSRI/SNRI
Placebo, taken as two tablets, once daily by mouth All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study.
干预措施: Placebo (Other)
结局指标
主要结局
Change From Baseline to Week 5 in the HAMD-17 Total Score
时间窗: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively
The Hamilton Rating Scale for Depression (HAMD-17) is a 17-item scale to assess depression. The HAMD-17 consists of 8 items with a score on a 3 point scale and 9 items with a score on a 5 point scale. Each item is rated from least (0) to most frequent or most severe, as applicable, with highest scores of 2 to 4, depending on the item. Items are summed up to calculate the HAMD-17 total score. The total score ranges from 0 to 52. A higher total score indicates more severe depression.
次要结局
- Change From Baseline to Week 5 in SF-12 Score(Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively)
- Change From Baseline to Week 5 in DAI-10 Score(Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively)
- Change From Baseline to Week 5 in the SDS Total Score(Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively)
- Treatment Response and Remission Rates at the End of 5-week Treatment Period(Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively)
- Change From Baseline to Week 5 in CGI-S Total Score(Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively)
- CGI-I Score at Week 5(Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively)
- Change From Baseline to Week 5 in KSS Score(Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively)
- Change From Baseline to Week 5 in MGH-SFI Score(Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively)
- Change From Baseline to Week 5 in BIS-11 Score(Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively)
- Change From Baseline to Week 5 in SIS Score(Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively)