A Multi-region, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating SEP-4199 Controlled Release (CR) for the Treatment of Major Depressive Episode Associated with Bipolar I Disorder (Bipolar I Depression)

Yabuuchi Kazuki0 个研究点目标入组 522 人开始时间: 2022年1月19日最近更新: 2024年4月23日

研究概览

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•Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.
•-Subject is 18 to 65 years of age, inclusive, at the time of informed consent.
•-Subject meets DSM-5 criteria, based on the SCID-5-CT, for bipolar I disorder, current episode depressed with or without rapid cycling disease course (>= 4 episodes of mood disturbance but < 8 episodes in the previous 12 months) with or without psychotic features.
•-Subject's current major depressive episode is >= 4 weeks and less than 12 months in duration at Screening.
•-Subject has a MADRS total score >= 22 at both Screening and Baseline.
•-Subject has a CGI-BP-S depression score >= 4 at both Screening and Baseline.
•-Subject has a YMRS total score =< 12 at both Screening and Baseline.
•-Subject is in good physical health, based on medical history, physical examination, neurological examination, vital signs, ECGs, and results of clinical laboratory tests (hematology, chemistry, and urinalysis).

•-Subject currently has any DSM-5 defined psychiatric diagnosis other than bipolar I disorder that was the primary focus of treatment, or is currently being treated with concomitant medication.
•-Subject has a lifetime history of, or symptoms consistent with, schizophrenia, schizoaffective disorder, or a major psychiatric diagnosis other than bipolar I disorder that is judged to pose risk to the study scientific objectives.
•-Subject has a history of non-response to an adequate (6-week) trial of 3 or more antidepressants (with or without mood stabilizers) during the current major depressive episode.
•-Subject was hospitalized during the Screening Period
•-Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that would pose a risk to the subject or that might confound the results of the study.

发起方

Yabuuchi Kazuki