A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of SEP-4199 for the Treatment of Major Depressive Episode Associated with Bipolar I Disorder

SUNOVION PHARMACEUTICALS INC.0 sites341 target enrollmentJuly 30, 2018

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: SUNOVION PHARMACEUTICALS INC.
Enrollment: 341
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 30, 2018

End Date

April 23, 2020

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

SUNOVION PHARMACEUTICALS INC.

Eligibility Criteria

Inclusion Criteria

•1\. Subject is 18 to 65 years of age, inclusive, at the time of informed consent with 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 (diagnosed by DSM 5 criteria, and confirmed by the SCID 5 CT). The current episode of major depression associated with bipolar I disorder must be confirmed by the Investigator and noted in the source records.
•2\. Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the investigator.
•3\. Subject must possess an educational level and degree of understanding of English or the local language that enables them to communicate suitably
•4\. Subject must have a lifetime history of at least one bipolar manic or mixed manic episode. It is strongly recommended that a reliable informant (eg, family member or caregiver) be available to confirm this history.
•5\. Subject’s current major depressive episode is \= 4 weeks and less than 12 months in duration at Screening.
•6\. Subject has a MADRS total score \= 22 at both Screening and Baseline.
•7\. Subject has a YMRS total score \= 12 at Screening.
•8\. Female subjects of childbearing potential must have a negative serum ß\-HCG test at Screening.
•9\. Females subject of childbearing potentialwho participate in this study must be one of the following:
•are unable to become pregnant (eg, postmenopausal, surgically sterile, etc.)

Exclusion Criteria

•1\. Subject has a lifel ong history or presence of symptoms consistent with a major psychiatric disorder other than bipolar I disorder as defined by DSM 5\. Exclusionary disorders include but are not limited to moderate to severe alcohol use disorder (within past 12 months), substance use disorder (other than nicotine or caffeine) within past 12 months, bipolar II disorder, schizoaffective disorder, obsessive compulsive disorder, posttraumatic stress disorder.
•2\. Subject demonstrates a decrease (improvement) of \= 25% in MADRS total score from Screening to Baseline, or subject’s MADRS total score is \< 22 at Baseline.
•3\. Subject has received treatment with antidepressants within 3 days of randomization, fluoxetine at any time within 28 days, an MAO inhibitor within 21 days or clozapine within 120 days. All other psychotropic medications with the exceptions of lorazepam, temazepam, and zolpidem require 3 days minimum washout. Depot neuroleptics must be discontinued at least one treatment cycle prior to randomization.
•4\. Subject has suspected/confirmed Borderline Personality Disorder.
•5\. Subject currently has a clinically significant neurological, metabolic (including type 1 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorder such as unstable angina, congestive heart failure (uncontrolled), or central nervous system (CNS) infection that would pose a risk to the subject if they were to participate in the study or that might confound the results of the study. Subjects with a known history of HIV seropositivity will be excluded.
•6\. Subject has evidence of any chronic organic disease of the CNS such as tumors, inflammation, active (or history of) seizure disorder, vascular disorder, Parkinson’s disease, Alzheimer’s disease or other forms of dementia, myasthenia gravis, or other degenerative processes. In addition, subjects must not have a history of intellectual disability or persistent neurological symptoms attributable to serious head injury. Past history of febrile seizure, is not exclusionary.
•7\. Subject has a history of malignancy \< 5 years prior to signing the informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Subjects with pituitary tumors of any duration are excluded.
•8\. Subject demonstrates evidence of acute hepatitis, clinically significant chronic hepatitis, or evidence of clinically significant impaired hepatic function through clinical and laboratory evaluation . Subject has a history of stomach or intestinal surgery or any other condition that could interfere with absorption, distribution, metabolism, or excretion of medications.
•9\. Subject has knowledge of any kind of cardiovascular disorder/condition known to increase the possibility of QT prolongation or history of additional risk factors for torsade de pointes (eg, heart failure, hypokalemia, family history of Long QT Syndrome or Brugada Syndrome) or cardiac conduction disorders, or requires treatment with an antiarrhythmic medication.
•10\. Subject has family history of QTc prolongation or of unexplainable sudden death at \< 50 years of age.