NCT05328297已完成2 期
A Randomized, Stratified, Double-blind, Placebo-Controlled Study to Investigate the Efficacy, Safety and Tolerability of JNJ-55308942 in Bipolar Depression
Janssen Pharmaceutica N.V., Belgium44 个研究点 分布在 4 个国家目标入组 116 人开始时间: 2022年6月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 44
- 主要终点
- Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Week 6
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of JNJ-55308942 compared to placebo on symptoms of depression in participants with bipolar disorder (BD) in a major depressive episode (MDE) at Week 6.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a primary diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnosis of bipolar disorder (BD) (Type I or II) without current psychotic features, as confirmed by the mini international neuropsychiatric interview (MINI)
- •Medically stable on the basis of physical examination, medical history, and vital signs performed at screening. Any abnormalities must be consistent with the underlying illness in the study population. This determination must be recorded in the participant's source documents and initialed by the investigator
- •Have a body mass index (BMI) between 18.0 and 35.0 kilograms per meter square (kg/m^2) inclusive (BMI = weight/height^2)
- •A woman of childbearing potential (WOCBP) must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test before the first dose of study intervention
排除标准
- •Currently meets the DSM-5 criteria for Manic Episode (ME) on the MINI
- •Received transcranial magnetic stimulation (TMS), any transcranial electrical stimulation, including transcranial direct current stimulation (tDCS), vagal nerve stimulation (VNS) and/or deep brain stimulation (DBS) within 6 weeks prior to randomization
- •History of moderate to severe cannabis misuse according to DSM-5 criteria within 6 months before screening
- •History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence)
研究组 & 干预措施
JNJ-55308942
Experimental
Participants will receive a JNJ-55308942 capsule once daily for 6 weeks.
干预措施: JNJ-55308942 (Drug)
Placebo
Placebo Comparator
Participants will receive a matching placebo capsule once daily for 6 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Week 6
时间窗: From Baseline (Day 1) up to Week 6
Change from baseline in MADRS total score up to Week 6 were reported. MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant (AD) treatment. The MADRS evaluated reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The scale consisted of 10 items, each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms),with higher score indicating a more severe condition. The MADRS total score was the sum of scores from individual question items and it ranged from 0 to 60, with higher scores indicated more severe conditions. Negative change in MADRS total score indicated improvement.
次要结局
- Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score up to Week 6(From Baseline (Day 1) up to Week 6)
- Change From Baseline in MADRS Total Score up to Week 6 (Genetic Subgroup Analysis)(From Baseline (Day 1) up to Week 6)
- Change From Baseline in MADRS Total Score up to Week 6 (Diagnosis Subgroup Analysis)(From Baseline (Day 1) up to Week 6)
- Change From Baseline in MADRS Total Score up to Week 6 (Biomarker Subgroup Analysis)(From Baseline (Day 1) up to Week 6)
- Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs(Weeks 1, 2, 4, 6, and 8 (Follow-up/Early Withdrawal))
- Change From Baseline in Clinical Laboratory Values in Male Hormone: Inhibin B(Baseline (Day 1), Week 4, 6, and 8 (Follow-up/Early Withdrawal))
- Change From Baseline in Clinical Laboratory Values in Male Hormone: Luteinizing Hormone(Baseline (Day 1), Week 4, 6, and 8 (Follow-up/Early Withdrawal))
- Change From Baseline in Clinical Laboratory Values in Male Hormone: Prolactin(Baseline (Day 1), Week 4, 6, and 8 (Follow-up/Early Withdrawal))
- Change From Baseline in Clinical Laboratory Values in Male Hormones: Sex Hormone Binding Globulin, Testosterone (Free), Testosterone (High Sensitivity), and Testosterone (Low Sensitivity)(Baseline (Day 1), Week 4, 6, and 8 (Follow-up/Early Withdrawal))
- Number of Participants With Abnormal Laboratory Values: Serum Chemistry(Weeks 2, 4, 6, and 8 (Follow-up/Early Withdrawal))
- Number of Participants With Clinically Significant Abnormal Laboratory Values: Hematology(Weeks 2, 4, 6, and 8 (Follow-up/Early Withdrawal))
- Number of Participants With Clinically Significant Abnormal Laboratory Values: Urinalysis(Weeks 2, 4, 6, and 8 (Follow-up/Early Withdrawal))
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Day 1 (Week 0) up to 30 days after the last dose (up to 11 weeks))
- Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs)(Weeks 1, 2, 4, 6, and 8 (Follow-up/Early Withdrawal))
- Change From Baseline in Young Mania Rating Scale (YMRS) Total Score(From Baseline (Day 1) up to Week 6)
- Number of Participants Who Reported Suicidal Ideation (SI) or Suicidal Behavior (SB) Using With Columbia Suicide Severity Rating Scale (C-SSRS) Score(From Baseline (Day 1) up to Week 8)
- Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score(From Baseline (Day 1) up to Week 6)
- Plasma Concentrations of JNJ-55308942(Predose, 1.5 hours and 4 hours post-dose on Week 0 (Day 1), Weeks 1 (Day 8), 2 (Day 15), 4 (Day 29), and 6 (Day 43))
- Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Score - Ability to Participate in Social Roles and Activities (APS) T-Scores(Baseline (Day 1), Weeks 1, 2, 3, 4, 5, and 6)
- Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score(Baseline (Day 1), Weeks 1, 2, 3, 4, 5, and 6)
- Change From Baseline in Generalized Anxiety Disorder 7 (GAD-7) Total Score(Baseline (Day 1), Weeks 2, 4, and 6)
- Number of Participants Who Achieved Response at Week 6(Week 6)
- Number of Participants Who Achieved Remission at Week 6(Week 6)
- Change From Baseline in MADRS Total Score up to Week 6 (Subgroup of Participants With Messenger Ribonucleic Acid [mRNA] Transcript Levels)(From Baseline (Day 1) up to Week 6)
- Change From Baseline in MADRS Total Score up to Week 6 (Concomitant Medication Subgroup Analysis)(From Baseline (Day 1) up to Week 6)
研究者
研究点 (44)
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