A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder.

Phase 3

Terminated

Interventions: Drug: SEP-4199 CR 200 mg
Drug: SEP-4199 CR 400 mg
Drug: Placebo

Brief 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.

Detailed Description: 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

Recruitment & Eligibility

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.

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6	6 Weeks	Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician-rated assessment of the subject's level of depression. The measure contains 10 items that measure apparent and reported sadness, inner tension, reduced sleep and appetite, difficulty concentrating, lassitude, inability to feel, and pessimistic and suicidal thoughts, each ranging from 0 to 6. The MADRS total score ranges from 0 to 60, with higher scores indicating increased depressive symptoms

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Global Severity Assessed by the Clinical Global Impressions Severity: Bipolar Version (CGI-BP-S) Score (Depression) at Week 6	6 Weeks	Clinical Global Impressions Severity: Bipolar Version (CGI-BP-S) score (depression) is a single value, clinician-rated assessment of illness severity, and 7-point scale with range from 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill subjects. A higher score is associated with greater illness severity.

Locations (88): University of Alabama at Birmingham Huntsville Regional Medical Campus
🇺🇸
Huntsville, Alabama, United States
Sanro Clinical Research Group LLC
🇺🇸
Bryant, Arkansas, United States
Advanced Research Center, Inc.
🇺🇸
Anaheim, California, United States
Sun Valley Research Center
🇺🇸
Imperial, California, United States
Clinical innovations, Inc.
🇺🇸
Riverside, California, United States
Siyan Clinical Research
🇺🇸
Santa Rosa, California, United States
Collaborative Neuroscience Research, LLC
🇺🇸
Torrance, California, United States
Vertex Research Group
🇺🇸
Clermont, Florida, United States
Sarkis Clinical Trials
🇺🇸
Gainesville, Florida, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸
Orlando, Florida, United States
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University of Alabama at Birmingham Huntsville Regional Medical Campus
🇺🇸Huntsville, Alabama, United States