Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment (ACP-103-054/059)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 298
- 试验地点
- 85
- 主要终点
- Change From Baseline to Week 5 in Hamilton Depression Scale (17 Items) (HAMD-17) Total Score
研究概览
简要总结
To evaluate the efficacy and safety of adjunctive pimavanserin compared to placebo in subjects with major depressive disorder who have an inadequate response to antidepressant therapy
详细描述
Two separate studies, idential in design, were planned and initiated under 2 protocol IDs and NCTs, i.e. study ACP-103-54 (NCT03999918) and ACP-103-059 (NCT03968159). In March 2020, recruitment of new patients was paused due to the emerging coronavirus disease 2019 (COVID-19) pandemic. At that point in time, about half of the planned patients had been randomized. The Sponsor decided to combine the 2 identically designed trials, with a prespecified combined statistical analysis plan. As a result, both trials were closed and proceeded with database lock and statistical analysis of the combined data. No further patients were enrolled.
This entry now includes the combined data of studies ACP-103-054 and ACP-103-059.
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:
- •Escitalopram
- •Venlafaxine
- •Desvenlafaxine
- •Venlafaxine XR
- •Inadequate response to SSRI/SNRI antidepressant treatment is confirmed
- •If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential OR must agree to use acceptable methods of contraception
排除标准
- •Has a history of psychotic disorder or is currently being treated or requires treatment for post-traumatic stress disorder, acute stress disorder, panic disorder, or obsessive compulsive disorder
- •Has current evidence of delirium or an unstable neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies that would affect the patient's ability to participate in the program
- •Has a known history or symptoms of long QT syndrome
- •Is determined to be inappropriate for the study for any reason
- •Additional inclusion/exclusion criteria apply. 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
Drug - pimavanserin
Pimavanserin 34 mg tablets
干预措施: Pimavanserin (Drug)
Placebo
Placebo tablets
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 5 in Hamilton Depression Scale (17 Items) (HAMD-17) Total Score
时间窗: Baseline, Week 5
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. The total score ranging from 0 to 52 will be calculated as the sum of the scores for all 17 items. Higher total scores denote more severe depression.
次要结局
- Change From Baseline to Week 5 in Clinical Global Impression-Severity (CGI-S) Score for Depressive Symptoms(Baseline, 5 weeks)
- Change From Baseline to Week 5 in Sheehan Disability Scale (SDS) Score(Baseline, 5 weeks)
- Change From Baseline to Week 5 in the Changes in Sexual Functioning Questionnaire Short Form(Baseline, 5 weeks)
- Change From Baseline to Week 5 in Karolinska Sleepiness Scale (KSS) Score(Baseline, 5 weeks)
- Change From Baseline to Week 1 in the HAMD-17 Total Score(Baseline, 1 week)
- Treatment Responder and Treatment Remission Rates at Week 5(Baseline, 5 weeks)
- Change From Baseline to Week 5 in the Hamilton Depression (HAMD) Anxiety/Somatization Factor Score(Baseline, 5 weeks)
- Change From Baseline to Week 5 in the Barratt Impulsiveness Scale (BIS-11)(Baseline, 5 weeks)
- Clinical Global Impression-Improvement (CGI-I) Score for Depressive Symptoms at Week 5(Baseline, 5 weeks)