EUCTR2020-003720-16-DE进行中（未招募）1 期
A double-blind, placebo-controlled, randomized dose-ranging trial to investigate efficacy and safety of intravenous MIJ821 infusion in addition to comprehensive standard of care on the rapid reduction of symptoms of Major Depressive Disorder in subjects who have suicidal ideation with intent
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 195
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
- •1. Signed informed consent must be obtained prior to participation in the study
- •2. Male and female participants, 18 to 65 years of age (inclusive), body weight from 50 kg to 120 kg (inclusive) at screening
- •3. DSM-5 defined major depressive disorder (MDD) with a current major depressive episode (MDE) without psychotic features at the time of screening based upon clinical assessment and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I.) assessed at Screening
- •4. Participants must have current suicidal ideation with intent, confirmed by a Yes response to Question B3 AND either Question B10 or Question B11 obtained from the M.I.N.I., assessed at Screening
- •5. Current suicidal ideation with intent, confirmed by Yes (>0) response to Question 3 AND either Question 9 or Question 10 obtained from the SSTS at Baseline
- •6. Montgomery-Åsberg Depression Rating Scale (MADRS) score > 28 at Screening and before randomization on Day 1
- •7. Participants must agree to receive pharmacological standard of care treatment to treat their MDD (as determined by the treating physician(s) based on clinical judgement and local treatment guidelines) during the trial duration
- •8. In the physician's opinion, acute psychiatric hospitalization is clinically warranted to treat the patient’s condition, and the patient is either already in the hospital or agrees to be hospitalized voluntarily for the required per protocol period
- •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 195
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any prior or current diagnosis of bipolar disorder, MDD with psychotic features, schizophrenia, or schizoaffective disorder as obtained from M.I.N.I. at Screening
- •2. Patients with acute alcohol or substance use disorder or withdrawal symptoms requiring detoxification, or patients who went through detoxification treatment (inpatient or outpatient) within 1 month before Screening.
- •3. Participant has a current clinical diagnosis of autism, dementia, or intellectual disability
- •4. History of seizures. Note: childhood febrile seizures are not exclusionary
- •5. Participants with current borderline personality disorder as obtained from M.I.N.I. at Screening.
- •6. Participants with suicidal ideation or behavior caused primarily by another non-MDD condition as obtained from M.I.N.I. at Screening
- •7. Known worsening or new appearance of suicidal ideation or behavior during a prior treatment with ketamine or esketamine or within 2 months after last ketamine or esketamine administration
- •8. Intake of the following medications: a. Esketamine or Ketamine within 2 months before Screening b. Monoamine oxidase inhibitors (MAOIs) within 14 days before Screening
- •9. Any other condition (e.g. known liver disease/liver dysfunction, active malignancy, etc.) which in the opinion of the investigator would put the safety of the participant at risk, impede compliance or hinder completion of the study.
研究者
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