A clinical study of an investigational drug for the treatment of Major Depressive Episode Associated with Bipolar I Disorder

JRCT ID: jRCT2031210559

Registered date:19/01/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: major depressive episodes associated with bipolar I disorder
• Date of first enrollment: 21/12/2021
• Target sample size: 522
• Countries of recruitment: United States of America,Japan,Bulgaria,Japan,Canada,Japan,Romania,Japan,Slovakia,Japan
• Study type: Interventional
• Intervention(s): SEP-4199 CR 200 mg/day, SEP-4199 CR 400 mg/day or placebo

Outcome(s)

• Primary Outcome: Change from Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) total score

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

-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).

Exclude criteria

-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.

Related Information

• Primary Sponsor: Yabuuchi Kazuki
• Secondary ID(s): NCT05169710,2021-002126-24