Major Depressive Episodes Associated with Bipolar I Disorder MedDRA version: 20.0 Level: PT Classification code 10004939 Term: Bipolar I disorder System Organ Class: 10037175 - Psychiatric disorders
Conditions
Sponsors
Sunovion Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 highly 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 highly 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 345 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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 AND a QTcF interval = 480 msec •increase in QTcF interval = 60 msec •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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety, tolerability, and effectiveness of SEP 4199 controlled release (CR) formulation at a flexible daily dose of 200 mg/day or 400 mg/day in subjects who previously completed a 6-week double-blind placebo-controlled lead-in study of SEP 4199 CR for the treatment of Major Depressive Episode associated with Bipolar I Disorder (Bipolar I Depression). Primary Objective: The primary objective of the current study is to evaluate long-term safety and tolerability of treatment with SEP-4199 CR 200-400 mg/day, as reflected in rates of adverse events (AE), discontinuations due to an AE, serious AEs (SAE), and adverse events of special interest (AESI). ;Secondary Objective: Additional Safety Objectives: Long-term safety and tolerability of flexible-dose SEP-4199 CR treatment will be evaluated as follows: •Measurements including 12-lead electrocardiogram (ECG), clinical laboratory values, vital signs, body weight, and metabolic parameters •Prolactin levels •Manic symptoms using the Young Mania Rating Scale (YMRS) •Suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS) •Movement disorders using the Barnes Akathisia Rating Scale (BARS), Abnormal Involuntary Movement Scale (AIMS), and modified Simpson Angus Scale (SAS) •Potential for withdrawal symptoms after discontinuation, using the Physician’s Withdrawal Checklist (PWC).;Primary end point(s): Safety Endpoints: •The incidence of overall AEs, discontinuation due to an AEs, and SAEs •The incidence of AESI including but not limited to hyperprolactinemia-related AEs •Clinical laboratory evaluations (chemistry, hematology, thyroid panel, urinalysis) •Clinical evaluation (vital signs including orthostatic effects, and 12-lead ECG measurements) •Changes in prolactin values •Changes in metabolic parameters (insulin, glucose, hemoglobin A1c (HbA1c), lipid panel) •Change and percent change in body weight •Change in BMI •Incidence of treatment-emergent mania, defined as a YMRS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Effectiveness Endpoints: •Changes in MADRS total score •Changes in CGI-BP-S depression score •The proportion of subjects with treatment response, defined as = 50% reduction from Baseline in MADRS total score •The proportion of subjects meeting criteria for remission, defined as MADRS total score = 12 •Changes in HAM-A total score •Changes in QIDS-SR16 total score •Changes in SDS total and subscale scores (work/school, family, and social function) •The proportion of subjects meeting criteria for functional remission, defined as having a score = 2 on each of the SDS subscale scores (work/school, family, and social function) •Changes in the EQ-5D-5L VAS and Index scores •Changes in the SHAPS total score ;Timepoint(s) of evaluation of this end point: Week 52 | — |
Countries
Bulgaria, Colombia, Croatia, Japan, Romania, Russian Federation, Serbia, Slovakia, Ukraine, United States
Contacts
Public ContactDr Steven Szabo
SUNOVION PHARMACEUTICALS INC.
Outcome results
None listed