NCT06462586已完成3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Lumateperone in the Acute Treatment of Patients With Manic Episodes or Manic Episodes With Mixed Features Associated With Bipolar I Disorder (Bipolar Mania)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 354
- 试验地点
- 43
- 主要终点
- Young Mania Rating Scale (YMRS)
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled, study in the acute treatment of patients with a diagnosis of bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania), with or without psychotic symptoms, according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).
详细描述
The study will be conducted in 3 phases:
- Screening Period (up to 1 week) during which patient eligibility will be assessed.
- Double-blind Treatment Period (3 weeks) during which all eligible patients will be randomized to receive lumateperone 42 mg or placebo in 1:1 ratio.
- Safety Follow-up Period (1 week) during which all patients will return to the clinic for a safety follow-up visit
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide written informed consent before the initiation of any study specific procedures;
- •Male or female inpatient, between the ages of 18 and 75 years, inclusive;
- •Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) criteria for bipolar I disorder with a current episode of mania or mania with mixed features with or without psychotic symptoms, as confirmed by a trained and Sponsor-approved rater using the modified Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT);
- •YMRS total score ≥ 20 and a score of at least 4 on two of the following YMRS items: irritability, speech, content, and disruptive/aggressive behavior at Screening and Baseline;
- •Hospitalized voluntarily before Screening or admitted to inpatient unit at Visit 1 with a primary diagnosis of mania but not > 14 days before Screening. Hospital admission must be a result of the current manic episode.
排除标准
- •Has a current primary DSM 5 psychiatric diagnosis other than bipolar disorder. These include:
- •Schizophrenia, schizoaffective disorder, or other psychotic disorders;
- •Dementia or other cognitive disorders;
- •Intellectual disability;
- •Moderate or severe substance use disorder (excluding for nicotine);
- •Experiencing first manic episode;
- •In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of his/her participation in the study or
- •At Screening, the patient scores "yes" on Items 4 or 5 in the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening; or
- •At Screening, the patient has had 1 or more suicidal attempts within 2 years prior to Screening; or
- •At Baseline, the patient scores "yes" on Items 4 or 5 in the Suicidal Ideation section of the C-SSRS since the Screening Visit; or
- •At Screening or Baseline, scores ≥ 4 on Item 10 (suicidal thoughts) on the rater administered Montgomery-Åsberg Depression Rating Scale (MADRS); or
- •Considered to be an imminent danger to himself/herself or others.
研究组 & 干预措施
Lumateperone 42 mg
Experimental
Lumateperone 42 mg capsules
干预措施: Lumateperone (Drug)
Placebo
Placebo Comparator
Matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Young Mania Rating Scale (YMRS)
时间窗: Week 3
The YMRS is an 11-item, clinician-administered mania rating scale designed to assess the severity of manic symptoms. Four of the YMRS items are rated on a 0 to 8 scale, with the remaining 7 items rated on a 0 to 4 scale. The total score ranges from 0 to 60 with a higher score indicating increased severity of manic symptoms.
次要结局
- Clinical Global Impression Scale-Severity (CGI-S)(Week 3)
研究者
研究点 (43)
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