2023-505892-56-00招募中3 期
Long-term Study to Assess the Safety and Effectiveness of NMRA-335140 in Participants with Major Depressive Disorder
Neumora Therapeutics Inc.31 个研究点 分布在 7 个国家目标入组 495 人开始时间: 2024年6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
- 495
- 试验地点
- 31
- 主要终点
- Safety and tolerability assessments based on adverse events (AEs), clinical laboratory parameters, electrocardiograms (ECGs), vital signs, physical examinations, ophthalmologic examination and corneal specular microscopy (CSM), Columbia Suicide Severity Rating Scale (C-SSRS), and Change in Sexual Functioning Questionnaire-14 (CSFQ-14).
研究概览
简要总结
The primary objective of the open-label, 52-week extension study is to evaluate the long-term safety and tolerability of NMRA-335140 80mg once daily (QD) in the treatment of major depressive disorder (MDD).
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Open-label, Long-term Follow Up Study
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Completed a previous NMRA-335140 Phase 3 MDD study (NMRA-335140-301, NMRA-335140-302, or NMRA-335140-303) according to the completion definition in the parent study protocol.
- •Signed an informed consent form (ICF) for this study. Note: For participants in the Czech Republic, every participant must have a caregiver participate in the study to help monitor compliance and safety during the study. The caregiver must be in personal contact with the participant at least 5 days a week in severely depressed participants or 2 days a week in moderately depressed participants and accompany the participant to study visits. The caregiver must sign a separate caregiver ICF.
- •Willing to comply with the contraception requirements described in the inclusion criteria of the parent study protocol.
- •Willing to comply with the concomitant medication/therapy restrictions described in the exclusion criteria of the parent study protocol.
排除标准
- •Diagnosed with another Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) disorder that would have been exclusionary in the parent study (eg, personality disorder, bipolar 1 or 2, schizophrenia, any other psychotic disorder, or moderate or severe substance or alcohol use disorder [excluding nicotine]).
- •Considered to be at significant risk of suicide in the judgment of the Investigator. This includes participants who are actively suicidal (eg, any suicide attempts during the parent study) or are at serious suicidal risk as indicated by any current suicidal intent, including a plan, as assessed by the C-SSRS ("Since Last Visit" version, score of "YES" on suicidal ideation Item 4 or 5) and/or based on clinical evaluation by the Investigator; or are homicidal, in the opinion of the Investigator.
- •Non-adherent with study medication (took less than or equal to 70% of study drug over any 2-week visit interval) or procedures during the parent study.
- •Experienced treatment emergent adverse events (TEAEs) considered related to the study medication from the parent study and judged by the Investigator to be clinically significant to render the participant ineligible for enrollment.
- •Have an abnormality on ocular examination that would prohibit continued study participation as determined by the Investigator.
- •Use of disallowed concomitant medication or therapy that would have been exclusionary in the parent study, may compromise the safety of the participant, and/or confound the interpretation of protocol assessments.
- •Considered by the Investigator to be inappropriate for any other reason.
结局指标
主要结局
Safety and tolerability assessments based on adverse events (AEs), clinical laboratory parameters, electrocardiograms (ECGs), vital signs, physical examinations, ophthalmologic examination and corneal specular microscopy (CSM), Columbia Suicide Severity Rating Scale (C-SSRS), and Change in Sexual Functioning Questionnaire-14 (CSFQ-14).
Safety and tolerability assessments based on adverse events (AEs), clinical laboratory parameters, electrocardiograms (ECGs), vital signs, physical examinations, ophthalmologic examination and corneal specular microscopy (CSM), Columbia Suicide Severity Rating Scale (C-SSRS), and Change in Sexual Functioning Questionnaire-14 (CSFQ-14).
次要结局
- Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score over time.
- Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score over time.
- Change from baseline in the Patient Health Questionnaire-9 (PHQ-9) total score over time.
- Change from baseline in PHQ-9 Anhedonia Item #1 over time.
- Change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) total score over time.
- Change from baseline in the Clinical Global Impression of Severity (CGI-S) score over time
- Value at each timepoint assessed in the Clinical Global Impression of Improvement (CGI-I) score.
- Percentage of participants whose MADRS total score decreased by greater than or equal to 50% from baseline over time.
- Percentage of participants whose MADRS total score decreased to 10 or less over time.
- Change from baseline in the Sheehan Disability Scale (SDS) over time.
研究者
Paul Yeung
Scientific
Neumora Therapeutics Inc.
研究点 (31)
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