EUCTR2018-003252-20-SK进行中（未招募）1 期
A 52-Week Open-Label Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 420
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Completed the antecedent study, Study ACP 103 054 or Study ACP-103-059
- •2.May benefit from longer term therapy with open-label pimavanserin treatment in the judgment of the Investigator
- •3.Is willing and able to provide informed consent. Consent for the present study must be obtained prior to the procedures being performed at the Week 6/EOT visit of Study ACP 103 054 or Study ACP-103-059
- •4.Is capable of communicating with the site personnel, able to complete subject-reported outcome measures and can be reliably rated on assessment scales (in the opinion of the Investigator)
- •5.If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) OR must agree to use TWO clinically acceptable methods of contraception during the study and 1 month following completion of the study.
- •Acceptable methods of contraception include the following:
- •a.A barrier method, condom, diaphragm, or cervical cap with spermicide
- •b.Hormonal contraception, including oral, injectable, transdermal, or implantable methods
- •c.Intrauterine device (IUD)
- •Only one of the two clinically acceptable methods can be a hormonal method.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 255
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1.Is judged by the Investigator or the Medical Monitor to be inappropriate for the study, due to adverse events, medical condition, or noncompliance with investigational product or study procedures in Study ACP-103-054 or Study ACP-103-059, or is judged to be a danger to self or others
- •2.Has any of the following electrocardiogram (ECG) results at Baseline (i.e.: Week 6/EOT visit of Study ACP-103-054 or Study ACP-103-059):
- •a.If the subject is not on citalopram, escitalopram, or venlafaxine (immediate or extended release):
- •i.QTcF >450 ms, if QRS duration <120 ms
- •ii.QTcF >470 ms, if QRS duration =120 ms
- •b.If the subject is on citalopram, escitalopram, or venlafaxine (immediate or extended release):
- •i.QTcF >425 ms, if QRS duration <120 ms
- •ii.QTcF >450 ms, if QRS duration =120 ms
- •3.Has a heart rate (as measured by peripheral pulse rate) <50 beats per minute at Baseline (i.e., the Week 6/EOT visit of Study ACP 103 054 or Study ACP-103-059) not explained by regular exercise or medication, in discussion with the Medical Monitor
- •4.Has a body mass index (BMI) <18.5 kg/m2 or known unintentional clinically significant weight change (i.e., +/- =7% of body weight) in Study ACP 103 054 or Study ACP-103-059 as assessed by the Investigator
- •5.Has clinically significant laboratory abnormalities that, in the judgment of the Investigator or Medical Monitor, would either:
- •a.jeopardize the safe participation of the subject in the study; OR
- •b.would interfere with the conduct or interpretation of safety or efficacy evaluations in the study
- •6.Is suicidal as defined below at Visit 1 (Baseline) of the present study:
- •a.An answer of yes” to C SSRS questions 4 or 5 (current or over the last 6 months); OR
- •b.Has attempted suicide within 1 year prior to Visit 1 (Baseline); OR
- •c.Is actively suicidal in the Investigator’s judgment
- •7.Has developed delirium or a neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or mental disorder, including cancer or malignancies that, in the judgment of the Investigator or the Medical Monitor, would increase the risk associated with taking study medication or significantly interfere with the conduct or interpretation of the study
- •8.Requires treatment with a medication or other substance that is prohibited by the protocol
- •9.Has a significant sensitivity or allergic reaction to pimavanserin or its excipients
- •10.Is an employee or is a family member of an employee of ACADIA Pharmaceuticals Inc.
研究者
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