A Multicentre, Open-Label, Phase 2 Safety Extension Study to Evaluate the Safety and Tolerability of R-107 in subjects with Refractory Major Depressive Disorder.

Douglas Pharmaceuticals Ltd.0 个研究点目标入组 153 人开始时间: 2018年6月22日最近更新: 2022年11月14日

适应症

试验速览

暂无简介。

•Subjects must meet all of the following criteria:
•1. Provision of written informed consent prior to any study specific procedures
•2. Female or male subjects aged 18-81 years inclusive at the time of enrolment (Screening visit).
•3. Enrolled into the double-blind treatment phase of the R107-C205 (BEDROC) study.
•4. Met relapse criteria at or before Day 92 of the R107-C205 study; or have completed the R107-C205 study.
•5. Treatment resistance in major depression defined as lack of clinically meaningful improvement despite the use of adequate doses of at least two antidepressant agents, derived from the group(s) of commonly used first line treatment, prescribed for adequate duration with adequate affirmation of treatment adherence.

•Subjects must NOT meet any of the following exclusion criteria to be enrolled:
•1. Any significant disease or disorder (e.g., cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient’s ability to participate in the study.
•2. Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening and at baseline, which in the opinion of the Investigator, may put the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subject’s ability to complete entire duration of the study.
•3. Any ECG abnormality obtained during the screening period that in Investigator’s judgement may put the patient at risk or negatively affect the outcome of the study.
•4. Pregnant, breastfeeding, or lactating women (Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1).
•5. Significant current risk of suicide

发起方