BPL-003 治疗难治性抑郁症的疗效和安全性
评估鼻内 BPL-003 治疗难治性抑郁症患者疗效和安全性的四重掩蔽剂量探索研究
研究概览
详细说明
大约 225 名符合条件的参与者将接受单剂量的低、中或高剂量 BPL-003，鼻内给药，并进行 8 周的随访评估。
将在给药前、给药期间和给药后给予心理支持。
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Berlin、德国、10117
- Charité - Universitätsmedizin Berlin
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Berlin、德国、10247
- OVID Clinic, Augmented Psychotherapy
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Frankfurt am Main、德国、60528
- Department of Psychiatry, University Hospital Frankfurt
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Mannheim、德国、68159
- Central Institute of Mental Health, Dept. of Molecular Neuroimaging
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Tübingen、德国、72076
- Universitätsklinik für Psychiatrie und Psychotherapie, Calwerstr. 14
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Gdansk、波兰、80-546
- Centrum Badan Klinicznych PI-House sp. z o.o.
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Gdansk、波兰、80-214
- Department of Psychiatry, UCK
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Lodz、波兰、92-216
- SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
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Tuszyn、波兰、95-080
- Klinika Inventiva
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Warsaw、波兰、02-957
- Department of Pharmacology and Physiology of CNS
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Melbourne、澳大利亚、3053
- NeuroCentrix Research
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Parkville、澳大利亚、3050
- Royal Melbourne Hospital, University of Melbourne
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New South Wales
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Sydney、New South Wales、澳大利亚、2050
- Royal Prince Alfred Hospital
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Victoria
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Clayton、Victoria、澳大利亚、3168
- Dept. of Psychiatry and School Psychological Sciences, Monash University
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Alabama
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Birmingham、Alabama、美国、35209
- UAB School of Public Health, Department of Health Behavior
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Arkansas
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Rogers、Arkansas、美国、72758
- Woodland Research Northwest
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California
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San Diego、California、美国、92037
- Kadima Neuropsychiatry Institute
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San Francisco、California、美国、94114
- San Francisco Insight and Integration Center
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Santa Monica、California、美国、90404
- Pacific Neuroscience Institute, Treatment and Research in Psychedelics (TRIP) Program
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Colorado
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Fort Collins、Colorado、美国、80525
- Wholeness Center
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Florida
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Lauderhill、Florida、美国、33319
- Segal Trials Center for Psychedelic and Cannabis Research
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Georgia
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Atlanta、Georgia、美国、30331
- CenExel ACMR
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Atlanta、Georgia、美国、30329
- Emory University, Brain Health Center, Department of Psychiatry and Behavioral Sciences
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Decatur、Georgia、美国、30030
- CenExel iResearch
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Maryland
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Rockville、Maryland、美国、20850
- Sunstone Medical PC (Sunstone Therapies / Aquilino Cancer Center)
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Massachusetts
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Boston、Massachusetts、美国、02131
- Boston Clinical Trials
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New Jersey
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Berlin、New Jersey、美国、08009
- CenExel HRI
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New York
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New York、New York、美国、10032
- New York State Psychiatric Institute
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Oregon
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Portland、Oregon、美国、97227
- Portland Psychotherapy
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Texas
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DeSoto、Texas、美国、75115
- Insite clinical research
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Plano、Texas、美国、75093
- AIM Trials
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Utah
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Draper、Utah、美国、84020
- Cedar Clinical Research
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Wisconsin
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Madison、Wisconsin、美国、53705
- University of Wisconsin, Dept of Family Medicine & Community Health
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Exeter、英国、EX2 5DW
- NIHR Exeter Clinical Research Facility
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London、英国、W1G 8DR
- Clerkenwell Health
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London、英国、SE5 8AF
- King's College London - Institute of Psychiatry, Psychology & Neuroscience (IoPPN) - Centre for Affective Disorders (CfAD)
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Barcelona、西班牙、08003
- Hospital Del Mar
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Barcelona、西班牙、08029
- Parc Sanitari Sant Joan de Deu HD Numancia
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Barcelona、西班牙、08036
- Hospital Clinic de Barcelona, Psychiatry and Psychology Dept.
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Madrid、西班牙、28050
- Fundación de Investigación HM Hospital
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Oviedo、西班牙、33011
- Centro de Salud Mental La Corredoria
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Salamanca、西班牙、37005
- Centro Salud San Juan
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
纳入标准：
- 至少是中度重度抑郁症。
- 根据 MGH ATRQ 评估，诊断为 TRD 定义为对至少 2 种药物治疗的足够剂量和持续时间没有反应。
- 筛选和基线时汉密尔顿抑郁量表得分≥19。
- CGI-S ≥ 4 在筛选和基线。
- QIDS-SR-16 基线时≥13。
- 如果目前正在服用抗抑郁药物，愿意并且能够停用目前的抗抑郁药物。
排除标准：
- 目前或过去有精神分裂症、精神障碍（包括精神病性抑郁症）、双相情感障碍、妄想症、分裂情感障碍或任何其他严重精神障碍的病史。
- 目前的人格障碍。
- 一级精神分裂症、双相情感障碍、妄想症或分裂情感障碍的家族史。
- 当前酒精或物质使用障碍（咖啡因或尼古丁除外）。
- 参与者在任何时候对氯胺酮、艾氯胺酮、足够疗程的电休克疗法无反应，或接受过迷走神经刺激或脑深部刺激。
- 筛选开始前 12 个月内或给药前第 1 天有自杀意念或行为。
- 筛选前的最后 12 个月内有自杀企图和/或自残行为。
- 不受控制的医疗条件，例如 甲状腺机能减退/甲状腺机能亢进、糖尿病、肾功能衰竭。
- 历史或当前未控制的高血压。
- 筛选前 2 年内有癫痫症或任何癫痫发作。
- 在筛选期间对心电图有临床意义的结果。
- 研究者认为可能会干扰研究药物给药的给药时出现的任何鼻塞、堵塞或充血症状。
- 怀孕、哺乳或有生育能力且不愿在研究期间采取适当避孕措施的女性参与者。
- 性活跃且不愿在研究期间采取适当避孕措施的男性参与者。
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：高剂量
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单剂量鼻内给药
A single dose administered intranasally (administered as 2 nasal sprays, 10 minutes apart)
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实验性的：中剂量
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单剂量鼻内给药
A single dose administered intranasally (administered as 2 nasal sprays, 10 minutes apart)
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实验性的：单相
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单剂量鼻内给药
A single dose administered intranasally (administered as 2 nasal sprays, 10 minutes apart)
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实验性的：双相
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单剂量鼻内给药
A single dose administered intranasally (administered as 2 nasal sprays, 10 minutes apart)
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实验性的：Low dose (sub-therapeutic)
Active placebo comparator
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单剂量鼻内给药
A single dose administered intranasally (administered as 2 nasal sprays, 10 minutes apart)
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Core: Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Day 29 (12 mg vs 0.3 mg BPL-003)
大体时间：4 weeks
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The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. The MADRS was administered remotely throughout the trial by independent, centralized, qualified raters. The rater used the SIGMA to interview the participant, moving from broadly based questions about symptoms to more detailed questions that allowed the precise rating of symptom severity. The SIGMA provides structured probes to ensure standardization of administration and comprehensiveness of coverage of the 10 items of the scale. A higher MADRS score indicates more severe depression, with each item yielding a score of 0-6. Total overall scores therefore range from 0-60. The change from baseline in MADRS total score for 12 mg (high dose) vs 0.3 mg (low dose) BPL-003 at Day 29 was assessed. |
4 weeks
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OLE: Number of Participants With Treatment-emergent Adverse Events in the OLE
大体时间：8 weeks
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The safety of a second dose of BPL-003 given with psychological support to participants with TRD was assessed by the number and percentage of participants with treatment-emergent adverse events.
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8 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Core: Change From Baseline in MADRS Total Score at Day 8 (12 mg vs 0.3 mg BPL-003)
大体时间：1 week
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The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. The MADRS was administered remotely throughout the trial by independent, centralized, qualified raters. The rater used the SIGMA to interview the participant, moving from broadly based questions about symptoms to more detailed questions that allowed the precise rating of symptom severity. The SIGMA provides structured probes to ensure standardization of administration and comprehensiveness of coverage of the 10 items of the scale. A higher MADRS score indicates more severe depression, with each item yielding a score of 0-6. Total overall scores therefore range from 0-60. The change from baseline in MADRS total score for 12 mg (high dose) vs 0.3 mg (low dose) BPL-003 at Day 8 was assessed. |
1 week
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Core: Change From Baseline in MADRS Total Score at Day 29 (8 mg vs 0.3 mg BPL-003)
大体时间：4 weeks
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The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. The MADRS was administered remotely throughout the trial by independent, centralized, qualified raters. The rater used the SIGMA to interview the participant, moving from broadly based questions about symptoms to more detailed questions that allowed the precise rating of symptom severity. The SIGMA provides structured probes to ensure standardization of administration and comprehensiveness of coverage of the 10 items of the scale. A higher MADRS score indicates more severe depression, with each item yielding a score of 0-6. Total overall scores therefore range from 0-60. The change from baseline in MADRS total score for 8 mg (medium dose) vs 0.3 mg (low dose) BPL-003 at Day 29 was assessed. |
4 weeks
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Core: Change From Baseline in MADRS Total Score at Day 8 (8 mg vs 0.3 mg BPL-003)
大体时间：1 week
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The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. The MADRS was administered remotely throughout the trial by independent, centralized, qualified raters. The rater used the SIGMA to interview the participant, moving from broadly based questions about symptoms to more detailed questions that allowed the precise rating of symptom severity. The SIGMA provides structured probes to ensure standardization of administration and comprehensiveness of coverage of the 10 items of the scale. A higher MADRS score indicates more severe depression, with each item yielding a score of 0-6. Total overall scores therefore range from 0-60. The change from baseline in MADRS total score for 8 mg (medium dose) vs 0.3 mg (low dose) BPL-003 at Day 8 was assessed. |
1 week
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Core: Number of Participants With Treatment-emergent Adverse Events in the Core Trial Period
大体时间：8 weeks
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The safety of BPL-003 given with psychological support to participants with TRD was assessed by the number and percentage of participants with treatment-emergent adverse events.
Any clinically significant findings during the trial have been included as adverse events.
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8 weeks
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合作者和调查者
调查人员
- 研究主任：Kevin Craig, M.D.、Beckley Psytech Ltd
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.