A Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of RAP-219 for the Acute Treatment of Manic Episodes, With or Without Mixed Features, Associated With Bipolar I Disorder
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 253
- 试验地点
- 56
- 主要终点
- Young Mania Rating Scale (YMRS)
研究概览
简要总结
This is a clinical research study for an investigational drug called RAP-219 in participants with bipolar I disorder. This study is being conducted to determine if RAP-219 is safe and effective in participants experiencing mania associated with bipolar I disorder.
详细描述
This is a Phase 2, proof-of-concept, multi-center, randomized, double blind, placebo-controlled study designed to evaluate the efficacy, safety and tolerability of RAP-219 in adult participants experiencing mania associated with bipolar I disorder. This is a 3-week inpatient clinical trial.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of bipolar I disorder, with or without psychotic symptoms, as confirmed by the Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT). Episode may contain mixed features, as confirmed by Montgomery-Åsberg Depression Rating Scale (MADRS).
- •Had at least one prior documented manic episode (with or without psychotic symptoms) that required treatment, within 5 years prior to Visit 1
排除标准
- •History of any of the following diagnoses: a. schizophrenia; schizoaffective disorder; major depressive disorder; moderate or severe substance or alcohol use disorder; as assessed by the SCID-5-CT b. delirium, dementia, amnestic, or other cognitive disorders; borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorders; by medical history and/or Investigator opinion Note: Any other current diagnoses must be discussed with the Medical Monitor.
- •Rapid cycler, defined as experiencing ≥4 distinct mood episodes (ie, manic or depressive) each meeting full DSM-5 criteria in the previous 12 months, and each separated by ≥2 months of full or partial remission, or a switch to an episode of the opposite polarity, as assessed by the SCID-5-CT
研究组 & 干预措施
Placebo
Inert comparator matching the active treatment
干预措施: Placebo (Other)
Active Arm
Treatment with RAP-219
干预措施: RAP-219 (Drug)
结局指标
主要结局
Young Mania Rating Scale (YMRS)
时间窗: Baseline to End of Treatment at Week 3
The YMRS is a clinician administered scale that consists of 11 items used to assess the severity of manic symptoms (total scores range from 0 to 60). The higher the YMRS score, the more severe the subject's symptoms of mania.
Young Mania Rating Scale (YMRS)
时间窗: Baseline to End of Treatment at Week 3
The YMRS is a clinician administered scale that consists of 11 items used to assess the severity of manic symptoms (total scores range from 0 to 60). The higher the YMRS score, the more severe the subject's symptoms of mania.
次要结局
- Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness Mania score(Baseline to end of Treatment at Week 3)
- Treatment Emergent Adverse Events (TEAEs)(Baseline to end of Study Period 8 Weeks after date of last dose)
- Heart Rate(Baseline to end of Study Period 8 Weeks after date of last dose)
- Respiratory Rate(Baseline to end of Study Period 8 Weeks after date of last dose)
- Body Temperature(Baseline to end of Study Period 8 Weeks after date of last dose)
- Blood Pressure(Baseline to end of Study Period 8 Weeks after date of last dose)
- Laboratory Analytes(Baseline to end of Study Period 8 Weeks after date of last dose)
- Electrocardiogram (ECG) QTc interval(Baseline to end of Study Period 8 Weeks after date of last dose)
- Electrocardiogram (ECG) abnormal findings(Baseline to end of Study Period 8 Weeks after date of last dose)
- Suicidality(Baseline to end of Study Period 8 Weeks after date of last dose)
- Body Temperature(Baseline to end of Study Period 8 Weeks after date of last dose)
- Suicidality(Baseline to end of Study Period 8 Weeks after date of last dose)
- Electrocardiogram (ECG) abnormal findings(Baseline to end of Study Period 8 Weeks after date of last dose)
- Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness Mania score(Baseline to end of Treatment at Week 3)
- Treatment Emergent Adverse Events (TEAEs)(Baseline to end of Study Period 8 Weeks after date of last dose)
- Respiratory Rate(Baseline to end of Study Period 8 Weeks after date of last dose)
- Heart Rate(Baseline to end of Study Period 8 Weeks after date of last dose)
- Blood Pressure(Baseline to end of Study Period 8 Weeks after date of last dose)
- Laboratory Analytes(Baseline to end of Study Period 8 Weeks after date of last dose)
- Electrocardiogram (ECG) QTc interval(Baseline to end of Study Period 8 Weeks after date of last dose)