An extension study to evaluate the long term safety, tolerability and effectiveness of SEP-4199 CR in patients with major depressive episodes associated with Bipolar I disorder.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 355

Inclusion Criteria

1.Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the investigator.
2.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.
3.Subject is medically appropriate for long-term open-label treatment with SEP 4199 CR in the opinion of the Investigator.
4.Female subjects of childbearing potential must agree to use effective and reliablecontraception throughout the study and for at least 30 days after the last dose of study drug hasbeen taken. In the Investigator’s judgment, the subject will adhere to this requirement.Contraception requirements are detailed in Section 10.4.
5.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. Contraception requirements are detailed in Section 10.4.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 355
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Subject is at high risk of non-compliance in the opinion of the Investigator.
2.Subject plans to initiate treatment with a prohibited psychotropic medication during the study.
3.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.
4.Subject experienced a moderate or severe hyperprolactinemia-related AESI in lead-in study of SEP-4199 CR.
5.Subject will require treatment with a drug that is associated with increases in QTc interval (see Section 23, Appendix IV for a list of medications, not all inclusive).
6. 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 from Baseline of the lead-in study of SEP-4199 CR AND a QTcF interval = 480 msec
•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.
7.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.
8.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.
9.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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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