EUCTR2018-000063-88-SE进行中（未招募）1 期
A Randomized, Double-blind, Placebo- and Active- controlled, Multicenter Study of Rapastinel as Monotherapy in Major Depressive Disorder
Allergan Ltd.0 个研究点目标入组 690 人开始时间: 2018年11月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 690
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
- •?Male and female outpatients who are 18 to 75 years of age
- •?Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD (based on confirmation from the Structured Clinical Interview for Diagnostic Statistic Manual of Mental
- •Health Disorders, Fifth Edition [SCID]), with a current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1
- •?Have a minimum score of 26 on the rater-administered Montgomery-Åsberg Depression Rating Scale (MADRS) and a minimum score of 24 on the computer administered MADRS at screening (Visit 1) and baseline (Visit 2)
- •?Have a Clinical Global Impressions - Severity (CGI-S) score of = 4 at screening and baseline
- •?Inadequate response (< 50% reduction in depressive symptoms) to 1 to 3 antidepressant therapies [ADTs] given at adequate doses (as defined by the ADT package insert) and duration of = 4 weeks during the present episode as documented using the Antidepressant
- •Treatment Response Questionnaire [ATRQ]
- •Note: Dose, duration, and likely adherence to antidepressant treatment should be verified by the investigator using the medical, pharmacy records, or communication with the treating physician.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 621
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 69
排除标准
- •?DSM-5–based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1. Comorbid generalized anxiety disorder, social anxiety disorder, or specific phobias are acceptable provided they play a secondary role in the balance of symptoms and are not the primary driver of treatment
- •? Lifetime history of meeting DSM-5 criteria for:
- •a. Schizophrenia spectrum or other psychotic disorder
- •b. Bipolar or related disorder
- •c. Major neurocognitive disorder
- •d. Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the patient’s ability to consent, follow study directions, or otherwise safely participate in the study
- •e. Dissociative disorder
- •f. Posttraumatic stress disorder
- •g. MDD with psychotic features
- •?History of meeting DSM-5 criteria for alcohol or substance use disorder (other than nicotine or caffeine) within the 6 months before Visit 1
- •? DSM-5–based diagnosis of any personality disorder of sufficient severity to interfere with participation in this study in the opinion of the investigator
- •? History (based on patient report, medical records, and investigator judgement) of:
- •a. Inadequate response to electroconvulsive therapy (ECT), a monoamine oxidase inhibitor or ketamine
- •b. Treatment with clozapine or any depot antipsychotic (exception: episodic use of clozapine at doses = 150 mg/day for the treatment of insomnia)
- •c. ECT, vagus nerve stimulation, transcranial magnetic stimulation, or any experimental central nervous system treatment during the current episode or in the 6 months before Visit 1 (whichever is longer)
- •d. Tardive dyskinesia, serotonin syndrome, or neuroleptic malignant syndrome
- •e. Intolerance or hypersensitivity to rapastinel or vortioxetine
- •f. f. Inadequate response to previous treatment with vortioxetine at adequate doses and for adequate duration
- •Other Medical Criteria
- •16. Females of childbearing potential and male partners of females of
- •childbearing potential, not using a highly effective means of
- •contraception (Section 9.4.10.2 and Appendix V for contraceptive
- •27. Known bleeding tendencies or related disorders
- •?Having received:
- •a. Anticonvulsant/mood stabilizer, within 1 year prior to Visit 1
- •b. Antipsychotic in the current episode, with the exception of quetiapine = 50 mg/day or clozapine = 150 mg/day given for insomnia provided it can be safely discontinued prior to Visit 2
- •c. Treatment with lithium as an ADT augmentation agent in the current episode
- •? Positive result at Visit 1 from the urine drug screen (UDS) test for any prohibited medication. Exception: patients with a positive UDS at Visit 1 for opiates, cannabinoids or episodic use of benzodiazepines may be allowed in the study provided:
- •a. The drug was used for a legitimate medical purpose (any recreational use is exclusionary);
- •b. The drug can be discontinued prior to participation in the study (except for episodic use of benzodiazepines which may be continued); and
- •c. A repeat UDS is negative for these substances prior to enrollment (except for episodic use of benzodiazepines which may be continued)
- •?Suicide risk, as determined by meeting any of the following criteria:
- •a. A suicide attempt within the past year
- •b. Significant risk, as judged by the investigator, based on the psychiatric interview or information collected in the C-SSRS at Visit 1 or Visit 2
- •c. MADRS Item 10 score = 5 at Visit 1 or Visit 2 on either the rater administered MADRS or computer
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