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

Sumitomo Pharma America, Inc.86 sites in 4 countries344 target enrollmentJune 26, 2018

ConditionsDepressive Episode Bipolar 1 Depression

InterventionsSEP-4199 200 mg SEP-4199 400 mg Placebo

DrugsSEP-4199 200 mg SEP-4199 400 mg Placebo

Overview

Phase: Phase 2
Intervention: SEP-4199 200 mg
Conditions: Depressive Episode
Sponsor: Sumitomo Pharma America, Inc.
Enrollment: 344
Locations: 86
Primary Endpoint: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A clinical study to test the effectiveness of an investigational drug to treat people that have major depressive episodes when they have Bipolar 1 Depression

Detailed Description

This is a randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study designed to evaluate the efficacy, safety, and tolerability of treatment with SEP-4199 monotherapy given as 200 mg/day or 400 mg/day compared with placebo for the treatment of major depressive episodes associated with bipolar I disorder (bipolar I depression).

Registry

clinicaltrials.gov

Start Date

June 26, 2018

End Date

April 23, 2020

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sumitomo Pharma America, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the investigator.
•Subject or legally acceptable representative must possess an educational level and degree of understanding of English or the local language that enables them to communicate suitably with the Investigator and the study coordinator.
•Subject must have a lifetime history of at least one bipolar manic or mixed manic episode. It is strongly recommended that a reliable informant (e.g., family member or caregiver) be available to confirm this history.
•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 YMRS total score ≤ 12 at Screening.
•Female subjects of childbearing potential must have a negative serum ß-hCG test at Screening.
•Females who participate in this study must be . one of the following:
•unable to become pregnant (e.g., postmenopausal, surgically sterile, etc.) -OR-

Exclusion Criteria

•Subject has a lifelong history or presence of symptoms consistent with a major psychiatric disorder other than bipolar I disorder as defined by DSM
•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.
•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.
•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,eszopiclone, zopiclone, zolpidem and zolpidem CR require 3 days minimum washout. Depot neuroleptics must be discontinued at least one treatment cycle prior to randomization.
•Subject has suspected/confirmed Borderline Personality Disorder
•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.
•Note: Active medical conditions that are minor or well-controlled are not exclusionary if they do not affect risk to the subject or the study results. In cases in which the impact of the condition upon risk to the subject or study results is unclear, the Medical Monitor should be consulted. Any subject with a known cardiovascular disease or condition (even if under control) must be discussed with the Medical Monitor before being randomized in the study.
•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.
•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.
•Subject demonstrates evidence of acute hepatitis, clinically significant chronic hepatitis, or evidence of clinically significant impaired hepatic function through clinical and laboratory evaluation (use screening values for 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.

Arms & Interventions

SEP-4199 200 mg

SEP-4199 200 mg/day (supplied in two 100mg tablets)

Intervention: SEP-4199 200 mg

SEP-4199 400 mg

SEP-4199 400 mg/day (supplied in two 200mg tablets)

Intervention: SEP-4199 400 mg

Placebo

Placebo (supplied in two tablets/day

Intervention: Placebo

Outcomes

Primary Outcomes

Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6

Time Frame: 6 Weeks

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 Outcomes

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)