EUCTR2018-000064-28-HU进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel in the Prevention of Relapse in Patients with Major Depressive Disorder
Allergan Ltd.0 个研究点目标入组 1,400 人开始时间: 2018年9月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,400
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. Written informed consent, obtained from the patient before the initiation of any study specific procedures
- •2. Completion of RAP-MD-30, RAP-MD-31, or RAP-MD-32
- •3. Male or female outpatients, 18 to 75 years of age (at time of entry to lead-in study)
- •4. Normal physical-examination findings, clinical-laboratory test results, and ECG results from Visit 1 or abnormal results that are determined to be not clinically significant with regard to participation in the study by the investigator (Note: Because Visit 1 ECG and laboratory results will not be available on the day of Visit 1, patients can be discontinued at Visit 2 if upon receipt of results the investigator determines clinically significant abnormalities are present.)
- •5. If female of childbearing potential, has a negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test. Because Visit 1 pregnancy test results will not be available on the day of Visit 1, patients can be discontinued at Visit 2 if Visit 1 pregnancy test is positive.
- •6. Ability to follow study instructions and likely to complete all required visits
- •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 1260
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 140
排除标准
- •1. 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 or episodic use of benzodiazepines may be allowed in the study as described more detailed in the protocol
- •(Note: Because Visit 1 UDS results will not be available on the day of Visit 1, patients can be discontinued at Visit 2 if upon receipt of results the investigator determines exclusionary results are present.)
- •2. 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
- •c. MADRS Item 10 score = 5 on the MADRS at Visit 1 of this study or at any visit during participation in the lead-in study
- •3. At imminent risk of injuring self or others or causing significant damage to property, as judged by the investigator
- •4. Requiring concomitant treatment with any of the prohibited medications, supplements, or herbal products listed in Appendix III, including any psychotropic drug or any drug with psychotropic activity except as described in Section 9.4.9.1.
- •5. Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
- •6. Females of childbearing potential, not using a reliable means of contraception
- •7. Any change in overall medical condition since entry in to the lead-in study that is determined by the investigator to be clinically significant with regard to participation in the study, including but not limited to: vital signs, ECG parameters, laboratory parameters, psychiatric status and neurological status
- •8. Current enrollment in an investigational drug or device study or participation in such a study within 6 months of entry into this study with the exception of the lead-in rapastinel study (RAP-MD-30, RAP-MD-31, or RAP-MD-32)
- •9. Employee, or immediate relative of an employee, of the sponsor, any of its affiliates or partners, or the study center
- •10. Inability to speak, read, and understand the local language sufficiently to understand the nature of the study, to provide written informed consent, or to allow the completion of all study assessments
- •11. Patient has a condition or is in a situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
研究者
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