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2018年9月13日

概览

暂无简介。

注册库

who.int

开始日期

2018年9月13日

结束日期

待定

最后更新

6年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

Allergan Ltd.

•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

•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