a clinical study of an investigational drug for the treatment of major depressive episode associated with bipolar i disorder.

Conditions: Depressive Episodes, Bipolar I Depression

Summary: a clinical trial to study the efficacy and safety of an investigational drug in people with major depressive episodes associated with with bipolar i disorder (bipolar i depression) participants in the study will either receive the drug being studied or a placebo. the study will be conducted in approximately 90 sites in north america, europe, latin america and japan. it will be have both male and female participants ages 18-65. participation in the study will be approximately 10 weeks.

this study is a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety, and tolerability of treatment with sep-4199 cr at fixed doses of 200 mg/day or 400 mg/day compared with placebo for the treatment of major depressive episode associated with bipolar i disorder (bipolar i depression). the study is projected to randomize approximately 522 subjects innorth america, japan, europe and latin america, to sep-4199 cr 200 mg/day, sep-4199 cr 400 mg/day, and placebo treatment groups in a 1:1:1 ratio

Eligibility criteria:
inclusion criteria: inclusion criteria (not all inclusive): * 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). exclusion criteria: exclusion criteria (not all inclusive): * 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 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.

Keywords: depression, depressive episode, bipolar, bipolar 1, bipolar 1 depression