EUCTR2019-002992-33-AT进行中（未招募）1 期
A Randomized, Open-label, Rater-Blinded, Active-Controlled, International, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Flexibly Dosed Esketamine Nasal Spray Compared With Quetiapine Extended-Release in Adult and Elderly Participants With Treatment-Resistant Major Depressive Disorder Who are Continuing a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor - ESCAPE-TRD
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 622
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Each potential participant must satisfy all of the following criteria to be enrolled in the study:
- •1. male or female, 18 years (or older if the minimum legal age of consent in the country in which the study is taking place is >18 years) to 74 years of age, inclusive, at the time of signing the ICF.
- •2. at screening, each participant must meet DSM-5 diagnostic criteria for single-episode MDD or recurrent MDD, without psychotic features, based on clinical assessment and confirmed by the MINI.
- •3. at screening and baseline, each participant must have an IDS-C30 total score of =34.
- •4. must be on a current antidepressive treatment that includes an SSRI/SNRI at screening that resulted in nonresponse (less than 25%improvement of symptoms) after having been given at an adequate dosage (based on antidepressive dosages from SmPC [or local equivalent, if applicable]) for an adequate duration of at least 6 weeks and having been uptitrated to the maximum tolerated dose; however, at screening the participant must show signs of minimal clinical improvement to be eligible for the study. Clinical improvement of a participant on their current AD treatment will be retrospectively evaluated in a qualified psychiatric interview performed by an experienced clinician; additional guidance for this interview is provided in Section 8.1.1.1.
- •5. the current antidepressive treatment was immediately preceded by nonresponse to at least 1 but not more than 5 different consecutive treatments (all within the current moderate to severe antidepressive episode) with ADs taken at an adequate dosage for an adequate duration of at least 6 weeks and must be documented (as described in Appendix 3, Regulatory, Ethical, and Study Oversight Considerations: Source Documents) during screening.
- •6. must have been treated with at least 2 different antidepressive substance classes among the treatments taken at an adequate dosage for an adequate duration of at least 6 weeks resulting in nonresponse in the current moderate to severe depressive episode (including the current treatment with an SSRI/SNRI).
- •7. must be on a single oral SSRI/SNRI on Day 1 prior to randomization.
- •Participants who are taking combination ADs and/or augmentation at screening are eligible for the study. All AD treatments, including any augmenting substances, must be stopped prior to randomization on Day 1 according to applicable SmPCs (or local equivalents, if applicable), except the SSRI/SNRI to be continued;
- •8. must be medically stable based on physical examination, medical history, vital signs (including blood pressure) at screening. If there are any abnormalities that are not specified in the inclusion and exclusion criteria, their clinical significance must be determined by the investigator and recorded in the participant’s source documents.
- •9. must be comfortable with self-administration of nasal medication and be able to follow the nasal administration instructions provided.
- •10. must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
- •11. must sign a separate ICF at baseline (Day 1) visit if he or she agrees to provide optional biomarker and/or genomic (DNA and RNA) samples for research (where local regulations permit). Refusal to give consent for the optional biomarker and/or genomic DNA and RNA research samples does not exclude a participant from participation in the main study.
- •12. a woman of childbearing potent
排除标准
- •Any potential participant who meets any of the following criteria will be excluded from participating in the study:
- •1.received treatment with esketamine or ketamine in the current moderate to severe depressive episode.
- •2.received treatment with quetiapine extended- or immediate-release in the current moderate to severe depressive episode of a dose higher than 50 mg/day.
- •3.had depressive symptoms in the current moderate to severe depressive episode that previously did not respond to an adequate course of treatment with electroconvulsive therapy (ECT), defined as at least 7 treatments with unilateral/bilateral ECT.
- •4.has no signs of clinical improvement at all or with a significant improvement on their current AD treatment that includes an SSRI/SNRI as determined at screening by an experienced clinician during the qualified psychiatric interview.
- •5.received vagal nerve stimulation or has received deep brain stimulation in the current episode of depression.
- •6.has a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with psychotic features, bipolar or related disorders (confirmed by the MINI), obsessive compulsive disorder (current only), intellectual disability (DSM-5 diagnostic codes 317, 318.0, 318.1, 318.2, 315.8, and 319), autism spectrum disorder, borderline personality disorder, antisocial personality disorder, histrionic personality disorder, or narcissistic personality disorder.
- •7.age at onset of first episode of MDD was =55 years.
- •8.has homicidal ideation or intent, per the investigator's clinical judgment; or has suicidal ideation with some intent to act within 1 month prior to screening, per the investigator's clinical judgment; or based on the C-SSRS, corresponding to a response of Yes on Item 4
- •(active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) for suicidal ideation, or a history of suicidal behavior within the past year prior to screening. Participants reporting suicidal ideation with intent to act or suicidal behavior prior to the start of the acute phase should also be excluded.
- •9.history of moderate or severe substance use disorder or severe alcohol use disorder according to DSM-5 criteria, except nicotine or caffeine, within 6 months before the start of the screening or current clinical signs.
- •10.history (lifetime) of ketamine, PCP, lysergic acid diethylamide (LSD), or 3,4-methylenedioxy-methamphetamine (MDMA) hallucinogen-related use disorder.
- •11.has a neurodegenerative disorder (eg, Alzheimer's disease, vascular dementia, Parkinson's disease with clinical evidence of cognitive impairment) or evidence of mild cognitive impairment.
- •12.is currently suffering from seizures, has a history of epilepsy, Neuroleptic Malignant Syndrome, or Tardive Dyskinesia.
- •13.has one of the following cardiovascular-related conditions:
- •- cerebrovascular disease with a history of stroke or transient ischemic attack.
- •- aneurysmal vascular disease (including intracranial, thoracic, or abdominal aorta, or peripheral arterial vessels).
- •- history of intracerebral hemorrhage.
- •- coronary artery disease with myocardial infarction, unstable angina, or revascularization procedure (eg, coronary angioplasty or bypass graft surgery) within 12 months before baseline (Day 1). Participants who have had a revascularization performed >12 months prior to screening and are clinically stable and symptom-free, per investigator's clinical judgment, can be include
研究者
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