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临床试验 NCT07046494 针对双相情感障碍1型目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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卡片视图
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Bipolar I Disorder
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临床试验NCT07046494旨在研究治疗，主要针对双相情感障碍1型。这是一项II期 (第二期) 干预性研究试验，目前试验状态为招募中。试验始于2025年7月25日，计划招募224名患者。该研究由Rapport Therapeutics Inc.主导，预计于2026年12月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年11月24日。
简要概括
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.
官方标题
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
疾病
双相情感障碍1型其他研究标识符
- RAP-219-BPM-201
NCT编号
实际开始日期
2025-07-25
最近更新发布
2025-11-24
预计完成日期
2026-12
计划入组人数
224
研究类型
干预性研究
试验分期 (阶段)
II期 (第二期)
试验状态
招募中
关键词
Bipolar
Mania
Acute
In-patient
Manic State
Manic Episode
Mixed Features
Episode with Mixed Features
Mixed Mania
Bipolar Episode
Mania
Acute
In-patient
Manic State
Manic Episode
Mixed Features
Episode with Mixed Features
Mixed Mania
Bipolar Episode
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
四盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Active Arm Treatment with RAP-219 | RAP-219 RAP-219 tablets administered orally, once daily for 21 days |
安慰剂对照Placebo Inert comparator matching the active treatment | 安慰剂 Matching placebo tablets administered orally, once daily for 21 days |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Young Mania Rating Scale (YMRS) | 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. | Baseline to End of Treatment at Week 3 |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness Mania score | The CGI-BP Severity of Illness Mania score is a clinician-rated scale used to assess the severity of manic symptoms, depression and overall illness severity in individuals with bipolar disorder. The mania score ranges from 1 (not ill) to 7 (very severely ill), with higher scores indicating greater severity of manic symptoms. | Baseline to end of Treatment at Week 3 |
Treatment Emergent Adverse Events (TEAEs) | Incidence and severity of treatment-emergent adverse events (TEAEs). | Baseline to end of Study Period 8 Weeks after date of last dose |
Heart Rate | Change in Heart Rate (BPM) | Baseline to end of Study Period 8 Weeks after date of last dose |
Respiratory Rate | Change in Respiratory Rate (breaths per minute) | Baseline to end of Study Period 8 Weeks after date of last dose |
Body Temperature | Change in body temperature | Baseline to end of Study Period 8 Weeks after date of last dose |
Blood Pressure | Change in blood pressure (Hg mm) | Baseline to end of Study Period 8 Weeks after date of last dose |
Laboratory Analytes | Change in laboratory analytes (absolute value) | Baseline to end of Study Period 8 Weeks after date of last dose |
Electrocardiogram (ECG) QTc interval | Changes in electrocardiogram (ECGs); QTc prolongation | Baseline to end of Study Period 8 Weeks after date of last dose |
Electrocardiogram (ECG) abnormal findings | Shift table of normal to abnormal ECG findings | Baseline to end of Study Period 8 Weeks after date of last dose |
Suicidality | Incidence of suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS). | Baseline to end of Study Period 8 Weeks after date of last dose |
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- 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
- 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
Rapport Therapeutics Inc.研究中心联系人
联系人: Dawn F Fenton, (857) 323-9048, [email protected]
22 位于 1 个国家/地区的研究中心
Arkansas
Pillar Clinical Research - Little Rock, Little Rock, Arkansas, 72204, United States
Leslie Smith, MD, 联系人
Leslie Smith, MD, 主要研究者
招募中
Woodland International Research Group, Little Rock, Arkansas, 72211, United States
George Konis, MD, 联系人
George Konis, MD, 主要研究者
招募中
Woodland Research Northwest, Rogers, Arkansas, 72758, United States
Robert Billingsley, MD, 联系人
Robert Billingsley, MD, 主要研究者
招募中
California
Inland Psychiatric Medical Group - Chino, Chino, California, 91710, United States
Nandita Puchakayala, MD, 联系人
Nandita Puchakayala, MD, 主要研究者
招募中
Synergy Clinical Research Center - San Diego, Lemon Grove, California, 91945, United States
Charmaine Semeniuk, MD, 联系人
Charmaine Semeniuk, 主要研究者
招募中
Collaborative Neuroscience Research - Los Alamitos, Los Alamitos, California, 90720, United States
Haig Goenjian, MD, 联系人
Haig Goenjian, 主要研究者
招募中
NRC Research Institute - Orange, Orange, California, 92868, United States
Daniel Chueh, MD, 联系人
Daniel Chueh, MD, 主要研究者
招募中
CNRI - San Diego, LLC, San Diego, California, 92123, United States
Christopher Benbow, MD, 联系人
Christopher Benbow, MD, 主要研究者
招募中
Florida
NeuroBehavioral Hospitals of the Palm Beaches - South, Boynton Beach, Florida, 33426, United States
Mohammad Asim Nisar, MD, 联系人
Mohammad Asim Nisar, MD, 主要研究者
招募中
United Research Institute, Hialeah, Florida, 33012, United States
Patrick Pinchinat, MD, 联系人
Patrick Pinchinat, 主要研究者
招募中
CenExel - Hollywood, Hollywood, Florida, 33024, United States
Edwin Gomez, MD, 联系人
Edwin Gomez, MD, 主要研究者
招募中
Segal Trials - Miami Lakes Medical Research Early Phase, Inpatient & Outpatient Site, Miami Lakes, Florida, 33016, United States
Rishi Kakar, MD, 联系人
Rishi Kakar, MD, 主要研究者
招募中
Neuroscience Research Institute at Ambrosia, West Palm Beach, Florida, 33407, United States
Danesh Alam, MD, 联系人
Danesh Alam, MD, 主要研究者
招募中
Georgia
CenExel - Decatur, Decatur, Georgia, 30030, United States
Kimball Johnson, MD, 联系人
Kimball Johnson, MD, 主要研究者
招募中
Illinois
Pillar Clinical Research - Chicago, Chicago, Illinois, 60641, United States
Roueen Rafeyan, MD, 联系人
Roueen Rafeyan, MD, 主要研究者
招募中
Maryland
CenExel - Gaithersburg, Gaithersburg, Maryland, 20877, United States
Elia Acevedo-Diaz, MD, 联系人
Elia Acevedo-Diaz, 主要研究者
招募中
Missouri
Arch Clinical Trials, St Louis, Missouri, 63125, United States
Kulsoom Juniad, MD, 联系人
Kulsoom Juniad, MD, 主要研究者
招募中
New York
Richmond Behavioral Associates, Staten Island, New York, 10314, United States
Peter Weiden, 联系人
Peter Weiden, MD, 主要研究者
招募中
North Carolina
New Hope Clinical Research, Charlotte, North Carolina, 28211, United States
Kurian Abraham, MD, 联系人
Kurian Abraham, 主要研究者
招募中
Texas
Community Clinical Research, Inc., Austin, Texas, 78754, United States
Samuel Collier, MD, 联系人
Samuel Collier, MD, 主要研究者
招募中
HD Research - Memorial Hermann Village, Houston, Texas, 77043, United States
Dominick D'Aunno, MD, 联系人
Dominick D'Aunno, MD, 主要研究者
招募中
Pillar Clinical Research - Richardson, Richardson, Texas, 75080, United States
Scott Bartley, MD, 联系人
Scott Bartley, MD, 主要研究者
招募中