NCT07288320招募中2 期
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder Who Are Currently Experiencing a Manic Episode or Manic Episode With Mixed Features, With or Without Psychotic Symptoms, and Warrant Inpatient Hospitalization
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 9
- 主要终点
- Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Day 21
研究概览
简要总结
The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving manic symptoms in adults with bipolar I disorder who are currently experiencing an episode of mania with or without mixed features.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has a primary diagnosis of bipolar I disorder.
- •The participant has had at least 1 prior documented manic episode that required treatment.
- •The participant is experiencing an acute manic episode or manic episode with mixed features, with or without psychotic symptoms.
排除标准
- •Any unstable or poorly controlled medical condition or chronic disease (including history of neurological, hepatic, renal, cardiovascular, gastrointestinal, pulmonary, autoimmune, or endocrine disease that may affect study participation or results), or malignancy within 90 days before the start of screening.
- •Primary diagnosis is not bipolar I disorder.
- •History of clozapine treatment for treatment-resistant psychosis.
- •History of psychiatric hospitalization(s) for ≥30 consecutive days during the 90 days before the start of screening.
- •Note: Additional inclusion/exclusion criteria may apply, per protocol.
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will receive placebo matching NBI-1117568.
干预措施: Placebo (Drug)
NBI-1117568
Experimental
Participants will receive NBI-1117568.
干预措施: NBI-1117568 (Drug)
结局指标
主要结局
Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Day 21
时间窗: Baseline, Day 21
次要结局
- Change From Baseline in Clinical Global Impression - Severity Scale (CGI-S) Score at Day 21(Baseline, Day 21)
研究者
研究点 (9)
Loading locations...
相似试验
招募中
2 期
Evaluation of NBI-1117570 in Inpatient Adults With SchizophreniaSchizophreniaNCT07288333Neurocrine Biosciences120
招募中
2 期
Efficacy and Safety of JNJ-77242113 in Participants with Moderately to Severely Active Ulcerative ColitisUlcerative Colitis2023-504673-20-00Janssen - Cilag International102
进行中（未招募）
2 期
Taldefgrobep Alfa in Adults With Overweight and ObesityObesityNCT07281495Biohaven Therapeutics Ltd.150
已完成
1 期
A Study to Evaluate the Effect of Single Oral Dose of Balinatunfib on Cardiac Repolarization in Healthy Adult Participants.NCT07272629Sanofi48
招募中
2 期
Topical Ketotifen 0.25% for Secondary VestibulodyniaNCT07257029Center for Vulvovaginal Disorders54