A Quadruple Masked, Dose-Finding Study to Evaluate the Efficacy and Safety of Intranasal BPL-003, With Open Label Extension, in Patients With Treatment-Resistant Depression
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 84
- 主要终点
- Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
This is a Phase 2 study randomized, quadruple-masked, multi-center trial with an open-label extension (OLE), designed to investigate the efficacy and safety of BPL-003 in patients with treatment resistant depression (TRD).
详细描述
During the main part of the trial, approximately 200 eligible participants will receive a either a low (sub-therapeutic), medium, or high single dose of BPL-003, given intranasally, with 8 weeks of follow-up assessments.
Following this, participants may receive a second high dose of BPL-003 during the OLE, given intranasally as either a single spray or two sprays 10 minutes apart, with another 8 weeks of follow-up assessments.
Psychological support will be given before, during, and after each dose.
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)
盲法说明
CORE: Quadruple masking: participant, investigator, outcomes assessor, and sponsor.
OLE: Open-label extension.
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
- •Diagnosis of TRD.
- •History consistent with TRD.
- •Current depressive episode which is at least moderate in severity (Hamilton Depression Rating Scale score is ≥19 and Clinical Global Impression-Severity score is ≥4).
- •Willing and able to discontinue current antidepressants, if applicable.
排除标准
- •1. Other co-morbidities.
研究组 & 干预措施
Medium dose
干预措施: BPL-003 (Drug)
Biphasic
干预措施: BPL-003 (Drug)
Low dose (sub-therapeutic)
Active placebo comparator
干预措施: BPL-003 (Drug)
High dose
干预措施: BPL-003 (Drug)
Monophasic
干预措施: BPL-003 (Drug)
结局指标
主要结局
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
时间窗: 4 weeks
High compared to low dose of BPL-003. The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. A higher MADRS score indicates more severe depression, and each item yields a score of 0-6.
OLE Primary Safety Outcome Measure
时间窗: 8 weeks
To determine the safety of a second dose of BPL-003 given with psychological support to participants with TRD as assessed by treatment-emergent adverse events.
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)
时间窗: 4 weeks
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.
OLE: Number of Participants With Treatment-emergent Adverse Events in the OLE
时间窗: 8 weeks
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.
次要结局
- Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant abnormal laboratory tests(8 weeks)
- Safety of BPL-003 given with psychological support as assessed by incidence of suicidal ideation or behavior(8 weeks)
- Safety of BPL-003 given with psychological support as assessed by number and percentage of participants with adverse events(8 weeks)
- Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant ECG parameters compared(8 weeks)
- Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)(4 weeks and 1 week)
- Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant abnormal vital sign measurements(8 weeks)
- Plasma levels of 5-MeO-DMT and its metabolites(1 day)
- Core: Change From Baseline in MADRS Total Score at Day 8 (12 mg vs 0.3 mg BPL-003)(1 week)
- Core: Change From Baseline in MADRS Total Score at Day 29 (8 mg vs 0.3 mg BPL-003)(4 weeks)
- Core: Change From Baseline in MADRS Total Score at Day 8 (8 mg vs 0.3 mg BPL-003)(1 week)
- Core: Number of Participants With Treatment-emergent Adverse Events in the Core Trial Period(8 weeks)