CTRI/2025/03/082366尚未招募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).
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 350
- 试验地点
- 6
- 主要终点
- To assess the efficacy of lumateperone 42 mg administered once daily compared with placebo in the acute treatment of patients with manic episodes or manic episodes with mixed features associated with bipolar I disorder, as measured by change from baseline to end of Week 3 in Young Mania Rating Scale (YMRS) total score.
研究概览
简要总结
This is a global, 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).
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 (SFU) Visit approximately one week after the end of DBTP, or ET Visit if the patient does not complete the DBTP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •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, (DSM-5-TR, American Psychiatric Association, 2022) 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) and meets all of the following criteria: a.
- •The start of the current manic or manic with mixed features episode is ≤ 4 weeks prior to Screening (Visit 1) b.
- •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 (Visit 1) and Baseline (Visit 2) c.
- •Have at least moderate severity of illness based on CGI-S total score ≥ 4 at Screening (Visit 1) and Baseline (Visit 2)
- •Hospitalized voluntarily before Screening (Visit 1) or admitted to inpatient unit at Visit 1 with a primary diagnosis of mania but not greater than 14 days before Screening (Visit 1).
- •Hospital admission must be a result of the current manic episode.
- •Female of childbearing potential and agrees to use at least an acceptable method of birth control (including but not limited to hormonal contraception, intrauterine device, vasectomized partner, bilateral tubal occlusion, condom with or without spermicide, cap with spermicide, diaphragm with spermicide, sponge with spermicide, or double barrier methods) from the time informed consent is provided through the end of the SFU period.
- •Abstinence may be an acceptable form of birth control based on the Investigator’s judgment and familiarity with the patient’s “preferred and usual lifestyle
- •Ability to follow study instructions and likely to complete all required visits.
排除标准
- •Has a current primary DSM-5 psychiatric diagnosis other than bipolar disorder.
- •These include: a.
- •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 a.
- •At Screening (Visit 1), 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 b.
- •At Screening (Visit 1), the patient has had 1 or more suicidal attempts within 2 years prior to Screening (Visit 1); or c.
- •At Baseline (Visit 2), the patient scores “yes†on Items 4 or 5 in the Suicidal Ideation section of the C-SSRS since the Screening Visit; or d.
- •At Screening (Visit 1) or Baseline (Visit 2), scores less than or equal to 4 on Item 10 (suicidal thoughts) on the rater administered Montgomery-Ã…sberg Depression Rating Scale (MADRS); or e.
- •Considered to be an imminent danger to himself/herself or others.
结局指标
主要结局
To assess the efficacy of lumateperone 42 mg administered once daily compared with placebo in the acute treatment of patients with manic episodes or manic episodes with mixed features associated with bipolar I disorder, as measured by change from baseline to end of Week 3 in Young Mania Rating Scale (YMRS) total score.
时间窗: 3 weeks
次要结局
- To assess the efficacy of lumateperone 42 mg administered once daily compared with placebo in the acute treatment of patients with manic episodes or manic episodes with mixed features associated with bipolar I disorder, as measured by change from baseline to end of Week 3 in Clinical Global Impression-Severity (CGI-S) score.(3weeks)
研究者
研究点 (6)
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