A Clinical Trial to Determine the Long-term Safety and Tolerability of an Investigational Drug in People With Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression).

Phase 3

Terminated

Conditions: Depressive Episodes, Bipolar I Depression

Interventions: Drug: SEP-4199 CR

Registration Number: NCT05227209

Lead Sponsor: Sumitomo Pharma America, Inc.

Brief Summary: This is a clinical trial to determine the long-term safety and tolerability of an investigational drug in people with Major Depressive Episode Associated with Bipolar I Disorder (Bipolar I Depression). Participants in the study will receive the drug being studied. This study is accepting male and female participants between 18 and 65 years old who have completed Study SEP380-301. This study will be conducted in approximately 90 study centers worldwide. The treatment duration for this study is one (1) year.

Detailed Description: This is a 12-month open-label safety extension study to evaluate the long-term safety, tolerability, and effectiveness of SEP-4199 CR 200-400 mg/day in the treatment of subjects with bipolar I depression who previously completed a lead-in study of SEP-4199 CR.

The study will consist of a 12-month open-label flexible-dose treatment period, and a safety follow-up period. There are 15 scheduled visits, including a Baseline visit, 13 visits during the open-label treatment period, and 1 safety follow-up visit 7 (± 2) days after the last dose of study drug. If necessary, subjects may return to the clinic at anytime for an unscheduled visit

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 64

Inclusion Criteria

Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.
Subject has completed 6 weeks of double-blind treatment and all scheduled assessments from Visit 6/EOT (Day 42) of the lead-in study of SEP-4199 CR.
Subject is medically appropriate for long-term open-label treatment with SEP-4199 CR in the opinion of the Investigator.
Female subjects of childbearing potential must agree to use effective and reliable contraception throughout the study and for at least 30 days after the last dose of study drug has been taken. In the Investigator's judgment, the subject will adhere to this requirement.
Male subjects agree to avoid fathering a child and to use effective methods of birth control throughout the study and until at least 90 days after the last study drug administration.

Exclusion Criteria

Subject is at high risk of non-compliance in the opinion of the Investigator.
Subject plans to initiate treatment with a prohibited psychotropic medication during the study.
Subject plans to initiate treatment with transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), vagus nerve stimulation (VNS), or deep brain stimulation (DBS) during the study.
Subject experienced a moderate or severe hyperprolactinemia-related AESI in the lead-in study of SEP-4199 CR.
Subject will require treatment with a drug that is associated with increases in QTc interval.
Subject had any of the following at Visit 6/EOT (Day 42) of the lead-in study of SEP-4199 CR based on machine reading:
increase in QTcF interval of ≥ 30 msec AND a QTcF interval ≥ 480 msec, from baseline of the lead-in study of SEP-4199 CR AND a QTCF interval ≥ 480msec
increase in QTcF interval ≥ 60 msec, from baseline of the lead-in study of SEP-4199 CR
QTcF interval ≥ 500 msec
treatment-emergent clinically significant ECG abnormality.
Subject is considered by the Investigator to be at imminent risk of suicide or injury to self or others, has a MADRS item 10 (suicidal ideation) score ≥ 4, or answers "yes" to "suicidal ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at Visit 6/EOT (Day 42) of the lead-in study of SEP-4199 CR.
Female subject of childbearing potential, has a positive urine pregnancy test at Visit 6/EOT (Day 42) of the lead-in study of SEP-4199 CR or plans to become pregnant during the current study.
Subject tests positive for any drug of abuse or cannabis at Visit 6/EOT (Day 42) of the lead-in study of SEP-4199 CR

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SEP-4199 CR	SEP-4199 CR	SEP-4199 CR either 200 mg (one 200 mg tablet) or 400 mg (two 200 mg tablets) once daily during open-label flexible-dose treatment period.

Primary Outcome Measures

Name	Time	Method
Number of Subjects Who Experienced Adverse Events in Study	12 months	Incidence of adverse events
Number of Subjects Who Discontinued Due to Adverse Events	12 months	Incidence of adverse events leading to discontinuation
Number of Subjects Who Experienced Serious Adverse Events in Study	12 months	Incidence of Serious Adverse Events

Secondary Outcome Measures

Name	Time	Method
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Change From Baseline	12 months	Open Label (OL) Month 12 (LOCF) is defined as the last non-missing post-OL Baseline measurement up to and including the OL Month 12 measurement and within 9 days post the last dose of open-label extension study medication. The 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 item is scored in a range of 0 to 6 points and total score range is of 0 to 60 with higher scores indicating increased depressive symptoms.Individual items are then summed to determine total score.
Clinical Global Impression Bipolar Version (CGI-BP-S) Depression Score - Change From Baseline	12 months	Open Label (OL) Month 12 (LOCF) is defined as the last non-missing post-OL Baseline measurement up to and including the OL Month 12 measurement and within 9 days post the last dose of open-label extension study medication.The Clinical Global Impression Bipolar Version (CGI-BP-S) scale is a clinician-rated assessment of the subject's current illness state on a 7-point scale, where a higher score is associated with greater illness severity. Depression Score is one the individual item on CGI-BP-S Scale.The CGI-BP-S depression score takes one of the following values: 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 patients).

Trial Locations

Locations (68): University of Alabama at Birmingham Huntsville Regional Medical Campus
🇺🇸
Huntsville, Alabama, United States
Advanced Research Center, Inc.
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Anaheim, California, United States
Sun Valley Research Center
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Imperial, California, United States
Clinical innovations, Inc.
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Riverside, California, United States
Collaborative Neuroscience Research, LLC
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Torrance, California, United States
Sarkis Clinical Trials
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Gainesville, Florida, United States
Clinical Neuroscience Solutions, Inc.
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Orlando, Florida, United States
Premier Clinical Research Institute, Inc
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Miami, Florida, United States
Atlanta Behavioral Research, LLC
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Atlanta, Georgia, United States
Psych Atlanta, P.C.
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Marietta, Georgia, United States
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University of Alabama at Birmingham Huntsville Regional Medical Campus
🇺🇸Huntsville, Alabama, United States