The purpose of the study is to look at how safe and tolerable the study drug called lumateperone is and whether it works when given to adolescents for the treatment of bipolar (13 to 17 years old). This is a double-blind study meaning that participants may receive a placebo or the study drug.
CONTACT US ABOUT YOUTH BIPOLAR TRIALDepressive Bipolar I and II (Adolescents 13-17)
Description
Eligibility Criteria
Male or female patients 13 to 17 years of age; Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of bipolar I or II disorder with a current MDE without psychosis; Subject has a lifetime history of at least one manic or hypomanic episode. A reliable informant (eg, family member or caregiver) or medical records must be able to confirm this history; Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration.
Duration
Study duration will be approximately 9 weeks
Intervention
In this study, patients aged 13 to 17 with bipolar depression will receive lumateperone 42 mg capsules once daily in the evening.
Compensation
You may be compensated for your time and travel for each visit.
Categories
- Youth Clinical Trial