2024-519421-37-00招募中3 期
NBI-1065845-MDD3026: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-1065845 as Adjunctive Treatment in Subjects with Major Depressive Disorder (MDD)
Neurocrine Biosciences Inc.14 个研究点 分布在 4 个国家目标入组 55 人开始时间: 2025年7月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 55
- 试验地点
- 14
- 主要终点
- The primary endpoint for this study will be the change from baseline in total MADRS score at Day 56.
研究概览
简要总结
The primary objective for this study is to evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in subjects with MDD on improving symptoms of depression, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •1.Completed informed consent.
- •2.≥18 years of age at the time of signing the informed consent.
- •4.The subject has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder. The MDD diagnosis must be confirmed using the Mini-International Neuropsychiatric Interview (MINI) in a face-to-face evaluation.
- •5.The subject must be receiving oral antidepressant treatment(s) as defined in the protocol.
- •6.Subject must have an Inadequate Response (IR) to oral antidepressant treatments that were administered as adequate courses (dose, duration, adherence) in the current episode of depression, as assessed using the Massachusetts General Hospital - Antidepressant Treatment Response Questionnaire (MGH-ATRQ).
- •7.Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1).
- •Willing and able to comply with all study procedures and restrictions in the opinion of the investigator.
排除标准
- •1.A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD (assessed by the MINI); a comorbid personality disorder that has been evident outside of depressive episodes or that may interfere with participation in the study; or a diagnosis of neurodegenerative disorder (including but not limited to dementia), eating disorder (except binge eating disorder), schizophrenia, schizoaffective disorder, bipolar disorder, MDD with psychotic features or mixed features, intellectual disability, or mental disorder due to a general medical condition as defined in DSM-
- •2.Are considered by the investigator to be at imminent risk of suicide or injury to self or others.
- •6.The subject’s depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy (ECT) in the current major depressive episode, defined as at least 7 treatments with unilateral/bilateral ECT.
- •9.Pregnant (ie, positive pregnancy test at screening or baseline) or lactating or plans to become pregnant during the study.
- •10.An unstable medical condition or unstable chronic disease (including history of neurological [including cognitive impairment, myasthenia gravis], hepatic, renal, cardiovascular, gastrointestinal, pulmonary, autoimmune, or endocrine disease that may affect study participation or results) within 3 months before Day 1, or malignancy within 6 months before Day
- •11.Any laboratory abnormality suggestive of clinically significant, poorly or unmanaged, undiagnosed disease.
- •12.History of epilepsy, seizures, or convulsions
- •13.History of neurological abnormalities including brain injury (including traumatic injury), perinatal cerebropathy, and postnatal brain damage, blood- brain barrier abnormality, and cavernous angioma.
- •Any reason that makes the subject unsuitable for participation in this study (eg, subject is homeless, known to have difficulty complying with treatment or medical procedures, known to provide inaccurate medical information, or known to attempt participation in clinical trials inappropriately) per the investigator, Medical Monitor, and/or Sponsor.
结局指标
主要结局
The primary endpoint for this study will be the change from baseline in total MADRS score at Day 56.
The primary endpoint for this study will be the change from baseline in total MADRS score at Day 56.
次要结局
- Change from baseline in SDS total score at Day 56
- Change from baseline in CGI-S score at Day 56
研究者
Neurocrine Medical Information Call Center
Scientific
Neurocrine Biosciences Inc.
研究点 (14)
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