An Open-Label, Phase 2a Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BPL-003 in Patients With Treatment Resistant Depression
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 4
- 主要终点
- 1. To assess the safety and tolerability of single or multiple intranasal doses of BPL-003 in patients with treatment resistant depression
研究概览
简要总结
An open-label, multi-centre, Phase 2a study to evaluate the safety, tolerability, and pharmacodynamics of one and two doses of intranasal BPL-003 combined with psychological support, in patients with treatment resistant depression when administered as monotherapy or as adjunctive therapy with defined SSRIs (citalopram, escitalopram, sertraline or fluoxetine).
详细描述
Part 1: Up to 32 patients, across 2 parallel arms (Arms A and Arms B) will receive one of two single doses of BPL-003, given intranasally, with 12 weeks of follow-up assessments.
Part 2: Up to 40 patients, across 2 parallel arms (Arms A and Arms B) will receive two doses of BPL-003, given intranasally, with 10 weeks of follow-up assessments.
Psychological support will be given before, during and after dosing in Part 1 and Part 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosed with Major Depressive Disorder.
- •Diagnosed with TRD defined as failure to respond to an adequate dose and duration of at least 2 pharmacological treatments in the past 5 years prior to screening, at least one of which is during the current episode.
- •Montgomery-Asberg Depression Rating Scale score ≥24 at Screening.
- •Clinical Global Impression - Severity ≥4 at Screening.
- •Willing and able to discontinue current pharmacological anti-depressant therapy.
- •On current stable dose of pharmacological antidepressant therapy limited to one of 4 SSRIs (Arm B), i.e. either citalopram, escitalopram, sertraline or fluoxetine.
排除标准
- •Current or history of schizophrenia, psychotic disorder including psychotic depression, bipolar disorder, delusional disorder, schizoaffective disorder, or any other severe psychiatric disorder.
- •Current personality disorders.
- •First-degree family history of schizophrenia, bipolar disorder, delusional disorder, personality disorders or schizoaffective disorder.
- •Current alcohol or substance use disorder (other than caffeine or nicotine).
- •A participant who at any time, has been unresponsive to ketamine, esketamine, an adequate course of treatment with electroconvulsive therapy, or has received vagal nerve stimulation or deep brain stimulation.
- •Suicidal ideation with the intent to act or suicidal behaviour within the 12 months prior to the start of Screening or on Day 1 prior to dosing.
- •Suicide attempt and/or self-injurious behaviour within the last 12 months prior to Screening.
- •Uncontrolled medical conditions e.g. hypo/hyperthyroidism, diabetes, renal failure.
- •Seizure disorder or history of seizures (including febrile seizures).
- •Abnormal and clinically significant results on the physical examination, vital signs, electrocardiogram, or laboratory tests at Screening Baseline.
- •Any nasal obstruction, blockage, or symptoms of congestion at the time of dosing, that in the Investigator's opinion may interfere with administration of the study drug.
- •Currently receiving lithium, antipsychotics, serotonergic drugs (excluding the permitted SSRIs for arm B), psychostimulants, or any other prohibited medication.
- •Female patients who are pregnant or lactating, or of childbearing potential and not willing to use adequate forms of contraception.
- •Male patients who are sexually active and not willing to using adequate forms of contraception.
研究组 & 干预措施
Arm A
干预措施: BPL-003 (Drug)
Arm B
干预措施: BPL-003 (Drug)
结局指标
主要结局
1. To assess the safety and tolerability of single or multiple intranasal doses of BPL-003 in patients with treatment resistant depression
时间窗: Baseline to 12 weeks post dose
* Percentage of patients with treatment emergent adverse events * Percentage of patients with clinically significant abnormal laboratory tests * Percentage of patients with clinically significant abnormal vital signs * Percentage of patients with clinically significant findings in physical examination * Percentage of patients with clinically significant ECG parameters or cardiac telemetry abnormalities (Part 1 Arm B only) * Percentage of patients with suicidal ideation or behaviour
次要结局
未报告次要终点