• Able to provide consent as follows:

‣ The Legally Authorized Representative (LAR) must provide written, informed consent.

⁃ The patient must provide written assent;

• Male or female patients 10 to 17 years of age, inclusive;

• Have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of bipolar I or bipolar II disorder with a current MDE without psychosis as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL);

• Subject has a lifetime history of at least one manic or hypomanic episode.

• Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration;

• CDRS-R total score ≥ 45 with ≥ 5 on Item 11 (depressed feelings) at Screening and Baseline;

• Young Mania Rating Scale (YMRS) score ≤ 15 (with YMRS Item 1 \[elevated mood\] score ≤ 2) at Screening and Baseline.