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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)

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

83

In the placebo group, SEP-4199 CR 200 mg/day group, SEP-4199 CR 400 mg/day group and all SEP-4199 CR group (same order below), the number of males was 9, 10, 11, 21 and the number of females was 18, 17, 17, 34, respectively. The mean (SD) age was 43.9 (11.34) years, 46.7 (11.67) years, 42.8 (12.53) years, 44.7 (12.16) years. Baseline mean (SD) MADRS total score was 36.6 (5.64), 37.5(6.22), 37.6(4.92), 37.5 (5.54) and baseline mean (SD) CGI-BP-S (depression) score was 5(0.65), 5(0.68), 4.9(0.69), 4.9 (0.68).

A total of 83 subjects were randomized in this study. One subject, who was randomized but never received any dose of study medication, was not included in the reporting. The study drug was administered to 27 subjects, 27 subjects, 28 subjects and 55 subjects in the placebo group, SEP-4199 CR 200 mg/day group, SEP-4199 CR 400 mg/day group and all SEP-4199 CR group (same order below), respectively, and the treatment period (6 weeks) was completed in 24 subjects, 22 subjects, 25 subjects and 47 subjects. 3 subjects, 6 subjects, 3 subjects and 9 subjects discontinued during the treatment period.

No deaths were reported during the study. No serious adverse events that occurred during the treatment period were reported. In the placebo group (27 subjects), SEP-4199 CR 200 mg/day group (27 subjects), SEP-4199 CR 400 mg/day group (28 subjects), and all SEP-4199 CR group (55 subjects) (same order below), the incidence of adverse events (number of subjects experiencing adverse events) was 40.7% (11 subjects), 37.0% (10 subjects), 39.3% (11 subjects), and 38.2% (21 subjects), respectively. Common adverse events (2% or more in all SEP-4199 CR group and at least twice the incidence of the placebo group) were electrocardiogram QT prolonged (0%, 3.7%, 7.1%, 5.5%), increased appetite (0%, 3.7%, 3.6%, 3.6%), diarrhoea (0%, 3.7%, 3.6%, 3.6%), and weight increased (0%, 3.7%, 3.6%, 3.6%).

Compared with placebo, the LS mean (SE) differences in change from baseline of MADRS total score at Week 6 were -3.94 (2.857), -6.34 (2.837) and -5.14 (2.453) for SEP 4199 CR 200 mg/day group, SEP-4199 CR 400 mg/day group, and all SEP-4199 CR group (same order below), respectively, (MMRM). For CGI-BP-S (depression) score, these values were -0.11 (0.308), -0.31 (0.305), and -0.21(0.262) (MMRM).

The sponsor ended the study earlier than planned. This decision was not related to any safety issues or concerns. Results of this study tell us that treatment with SEP-4199 CR 200 mg and 400 mg once daily for 6 weeks was generally safe and well tolerated in participants with bipolar I depression.

Oct. 17, 2024

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2031210559

Yabuuchi Kazuki

Sumitomo Pharma Co., Ltd.

6-8, Doshomachi 2-chome,Chuo-ku,Osaka,Osaka 541-0045,Japan

cr@sumitomo-pharma.co.jp

Product information center

Sumitomo Pharma Co., Ltd.

6-8, Doshomachi 2-chome,Chuo-ku,Osaka,Osaka 541-0045,Japan

+81-120-034-389

cc@sumitomo-pharma.co.jp

Complete

Jan. 19, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- 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.

Both

major depressive episodes associated with bipolar I disorder

SEP-4199 CR 200 mg/day, SEP-4199 CR 400 mg/day or placebo

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

+81-3-5433-3343

Jan. 11, 2022

United States of America/Bulgaria/Canada/Romania/Slovakia