A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder.

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

A clinical trial to study the efficacy and safety of an investigational drug in people with major depressive episodes associated with with Bipolar I disorder (bipolar I depression) Participants in the study will either receive the drug being studied or a placebo. The study will be conducted in approximately 90 sites in North America, Europe, Latin America and Japan. It will be have both male and female participants ages 18-65. Participation in the study will be approximately 10 weeks.

Study Overview

• Status: Terminated
• Conditions: Depressive Episodes, Bipolar I Depression
• Intervention / Treatment: Drug: SEP-4199 CR 200 mg; Drug: SEP-4199 CR 400 mg; Drug: Placebo

Detailed Description

This study is a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety, and tolerability of treatment with SEP-4199 CR at fixed doses of 200 mg/day or 400 mg/day compared with placebo for the treatment of major depressive episode associated with bipolar I disorder (bipolar I depression). The study is projected to randomize approximately 522 subjects inNorth America, Japan, Europe and Latin America, to SEP-4199 CR 200 mg/day, SEP-4199 CR 400 mg/day, and placebo treatment groups in a 1:1:1 ratio

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Kardzhali, Bulgaria, 6600
    • State Psychiatric Hospital - Kardzhali First Women Department Third Men Department
  • Plovdiv, Bulgaria, 4004
    • Medical Center Mentalcare OOD
  • Ruse, Bulgaria, 7003
    • Mental Health Center- Ruse EOOD,Men Department for treatment of persons with acute psychotic disorders; Women Department for treatment of persons with acute psychotic disorders; Department "Daily stationary"
  • S. Tsarev Brod, Bulgaria, 9747
    • State Psychiatric Hospital - s. Tsarev brod First Department for Active Treatment - Men Second Department for Active Treatment - Men Women Department - Rehabilitation Sector Women Department - Acute Sector
  • Sofia, Bulgaria, 1510
    • Medical Center Hera Eood
  • Sofia, Bulgaria, 1113
    • Medical Center Sveti Naum EOOD
  • Sofia, Bulgaria, 1408
    • DCC St. Vrach and St. St. Kuzma and Damian OOD
  • Sofia, Bulgaria, 1680
    • Medical Center Intermedica OOD
  • Sofia, Bulgaria, 1000
    • Mental Health Center - Sofia EOOD
  • Varna, Bulgaria, 0920
    • DCC Mladost-M Varna OOD 15, Republika Blvd., MC Mladost, 3rd floor
• Canada
  • Ontario
    • Markham, Ontario, Canada, L3R 1A3
      • AMNDX Inc.
• Japan
  • Fukuoka-Ken
    • Fukuoka-Shi, Fukuoka-Ken, Japan, 810-0022
      • Shinseikai Kaku Mental Clinic
    • Fukuoka-shi, Fukuoka-Ken, Japan, 810-0004
      • Hiro Mental Clinic
    • Fukuoka-shi, Fukuoka-Ken, Japan, 810-0023
      • Mental Clinic Sakurazaka
    • Kitakyushu-shi, Fukuoka-Ken, Japan, 800-0226
      • Someikai Kanagami Clinic
    • Kitakyushu-shi, Fukuoka-Ken, Japan, 802-0006
      • Kokura Mental Clinic
    • Kitakyusyu-shi, Fukuoka-Ken, Japan, 802-0064
      • Hatakeyama Clinic
    • Kurume-shi, Fukuoka-Ken, Japan, 830-0033
      • Hirota Clinic
    • Omuta-shi, Fukuoka-Ken, Japan, 836-0004
      • Shiranui Hospital
  • Fukushima-Ken
    • Shirakawa-shi, Fukushima-Ken, Japan, 961-0021
      • Jisenkai Nanko Psychiatric Institute
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan, 006-8555
      • Teine Keijinkai Hospital
  • Hyogo-Ken
    • Kobe-shi, Hyogo-Ken, Japan, 651-0097
      • Tatsuta Clinic
  • Kagoshima-Ken
    • Kagoshima-shi, Kagoshima-Ken, Japan, 890-0069
      • Cerisier Heart Clinic
  • Kanagawa-Ken
    • Kawasaki-shi, Kanagawa-Ken, Japan, 211-0004
      • Musashikosugi J Kokorono Clinic
    • Sagamihara-shi, Kanagawa-Ken, Japan, 252-0303
      • Yutaka Clinic
    • Yokohama-shi, Kanagawa-Ken, Japan, 225-0011
      • Azamino Mental Clinic
    • Yokohama-shi, Kanagawa-Ken, Japan, 231-0846
      • Yamatenomori Kokorono Clinic
  • Kumamoto-ken
    • Kumamoto-shi, Kumamoto-ken, Japan, 861-8002
      • Satokai Yuge Hospital
  • Okinawa-ken
    • Naha-shi, Okinawa-ken, Japan, 900-0004
      • Akari Clinic
    • Urasoe-shi, Okinawa-ken, Japan, 901-2102
      • Shiroma Clinic
  • Saga-Ken
    • Karatsu-shi, Saga-Ken, Japan, 847-0031
      • Rainbow & Sea Hospital
  • Tokyo-To
    • Bunkyo-ku, Tokyo-To, Japan, 113-8431
      • Juntendo University Hospital
    • Meguro-ku, Tokyo-To, Japan, 152-0012
      • Senzoku Psychosomatic Clinic
    • Minato-ku, Tokyo-To, Japan, 107-0062
      • Minami-Aoyama Antique Street Clinic
    • Nakano-ku, Tokyo-To, Japan, 164-0012
      • Heart Care Ginga Clinic
    • Setagaya-ku, Tokyo-To, Japan, 154-0004
      • Sangenjaya Nakamura Mental Clinic
    • Setagaya-ku, Tokyo-To, Japan, 154-0004
      • Sangenjaya Neurology- Psychosomatic Clinic
    • Shibuya-ku, Tokyo-To, Japan, 150-8935
      • Japanese Red Cross Medical Center
    • Shibuya-ku, Tokyo-To, Japan, 151-0053
      • Maynds Tower Mental Clinic
    • Shibuya-ku, Tokyo-To, Japan, 151-0053
      • Sangubashi Kokorono Clinic
    • Shinagawa-ku, Tokyo-To, Japan, 141-0021
      • Etoh Mental Clinic
    • Shinjuku-ku, Tokyo-To, Japan, 160-0023
      • Tamaki Clinic
    • Shinjuku-ku, Tokyo-To, Japan, 162-0843
      • Himorogi Psychiatric Institute
    • Taito-ku, Tokyo-To, Japan, 110-0003
      • Uguisudani Mental Clinic
    • Toshima-ku, Tokyo-To, Japan, 170-0002
      • Ohwa Mental Clinic
    • Toshima-ku, Tokyo-To, Japan, 170-0011
      • Kitaikebukuro Kokoro No Clinic
• Romania
  • Brasov, Romania, 500123
    • Spitalul Clinic de Psihiatrie si Neurologie Brasov, Sectia Psihiatrie Clinică I
  • Bucuresti, Romania, 040874
    • Spitalul Clinic de Psihiatrie ''Prof. Dr. Alexandru Obregia''
  • Bucuresti, Romania, 060222
    • Sectia Psihiatrie, Centrul de Evaluare si Tratament al Toxicodependentelor pentru Tineri "Sfantul Stelian", Sectia Psihiatrie
  • București, Romania, 041914
    • Spitalul Clinic de Psihiatrie
  • Craiova, Romania, 200157
    • Institutul Privat De Cercetări Melchisedec, Pentru Boli Autoimune, Ereditare Şi Rare - I.P.C.M.
  • Iasi, Romania, 700282
    • Institutul de Psihiatrie Socola Iasi, Sectia Psihiatrie III Acuti
  • Iasi, Romania, 700282
    • Institutul de Psihiatrie Socola Iasi, Sectia Psihiatrie I Femei
• Slovakia
  • Rimavska Sobota, Slovakia, 979 01
    • PsychoLine s. r. o., Psychiatricka ambulancia
  • Vranov And Toplou, Slovakia, 093 01
    • Crystal Comfort s.r.o., Psychiatricka ambulancia
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • University of Alabama at Birmingham Huntsville Regional Medical Campus
  • Arkansas
    • Bryant, Arkansas, United States, 72022
      • Sanro Clinical Research Group LLC
  • California
    • Anaheim, California, United States, 92805
      • Advanced Research Center, Inc.
    • Imperial, California, United States, 92251
      • Sun Valley Research Center
    • Riverside, California, United States, 92506
      • Clinical Innovations, Inc.
    • Santa Rosa, California, United States, 95401
      • Siyan Clinical Research
    • Torrance, California, United States, 90502
      • Collaborative Neuroscience Research, LLC
  • Florida
    • Clermont, Florida, United States, 34711
      • Vertex Research Group
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions, Inc.
    • Miami, Florida, United States, 33122
      • Premier Clinical Research Institute, Inc.
    • Miami, Florida, United States, 33125
      • Central Miami Medical Institute
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions, Inc.
    • Tampa, Florida, United States, 33609
      • GCP Clinical Research LLC
  • Georgia
    • Atlanta, Georgia, United States, 30338
      • Atlanta Behavioral Research, LLC
    • Marietta, Georgia, United States, 30060
      • Psych Atlanta, P.C.
  • Illinois
    • Warrenville, Illinois, United States, 60555
      • AMR Conventions Research
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Dept. of Psychiatry & Behavioral Sciences, University of Louisville School of Medicine
  • Missouri
    • Saint Charles, Missouri, United States, 63304
      • St. Charles Psychiatric Associates / Midwest Research Group
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Alivation Research, LLC
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08002
      • Center for Emotional Fitness
    • Princeton, New Jersey, United States, 08540
      • Global Medical Institutes, LLC
  • New York
    • Buffalo, New York, United States, 14215
      • UB Department of Psychiatry
    • Rochester, New York, United States, 14618
      • Finger Lakes Clinical Research
    • Staten Island, New York, United States, 10312
      • Richmond Behavioral Associates ERG Clinical Research - New York PLLC
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
      • New Hope Clinical Research
  • Ohio
    • Avon Lake, Ohio, United States, 44012
      • Quest Therapeutics of Avon Lake
    • North Canton, Ohio, United States, 44720
      • Neuro-Behavioral Clinical Research, Inc
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Sooner Clinical Research
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Lehigh Center for Clinical Research, LLC
  • Texas
    • Austin, Texas, United States, 78754
      • Community Clinical Research, Inc.
    • Houston, Texas, United States, 77054
      • UTHealth Science Center at Houston
    • The Woodlands, Texas, United States, 77381
      • Family Psychiatry of The Woodlands
  • Utah
    • Saint George, Utah, United States, 84770
      • Integrated Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Inclusion Criteria (not all inclusive):

• Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.
• Subject is 18 to 65 years of age, inclusive, at the time of informed consent.
• Subject meets DSM-5 criteria, based on the SCID-5-CT, for 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.
• 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 CGI-BP-S depression score ≥ 4 at both Screening and Baseline.
• Subject has a YMRS total score ≤ 12 at both Screening and Baseline.
• Subject is in good physical health, based on medical history, physical examination, neurological examination, vital signs, ECGs, and results of clinical laboratory tests (hematology, chemistry, and urinalysis).

Exclusion Criteria:

Exclusion Criteria (not all inclusive):

• Subject currently has any DSM-5 defined psychiatric diagnosis other than bipolar I disorder that was the primary focus of treatment, or is currently being treated with concomitant medication
• Subject has a lifetime history of, or symptoms consistent with, schizophrenia, schizoaffective disorder, or a major psychiatric diagnosis other than bipolar I disorder that is judged to pose risk to the study scientific objectives
• Subject has a history of non-response to an adequate (6-week) trial of 3 or more antidepressants (with or without mood stabilizers) during the current major depressive episode.
• Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that would pose a risk to the subject or that might confound the results of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo tablet (supplied in two tablets)
Experimental: SEP-4199 CR 200 mg; SEP-4199 CR 200 mg/day	Drug: SEP-4199 CR 200 mg; SEP-4199 CR 200 mg Tablet (supplied in one 200mg tablet and one placebo tablet)
Experimental: SEP-4199 CR 400 mg; SEP-4199 CR 400 mg/day	Drug: SEP-4199 CR 400 mg; SEP-4199 CR 400 mg tablet (supplied in two 200mg tablets)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) total score	The Montgomery-Asberg Depression Rating Scale (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, with higher scores indicating increased depressive symptoms.	Baseline and Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline to Week 6 in Clinical Global Impressions-Severity: Bipolar Version (CGI-BP-S) depression score	Clinical Global Impressions - Severity: Bipolar Version (CGI-BP-S) is 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.	Baseline and Week 6

Collaborators and Investigators

• Sponsor: Sumitomo Pharma America, Inc.
• Investigators: Study Chair: CNS Medical Director, Sumitomo Pharma America, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2021
• Primary Completion (Actual): October 18, 2023
• Study Completion (Actual): October 18, 2023

Study Registration Dates

• First Submitted: December 13, 2021
• First Submitted That Met QC Criteria: December 13, 2021
• First Posted (Actual): December 27, 2021

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Depression, Depressive episode, Bipolar, Bipolar 1, Bipolar 1 depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: SEP380-301; 2021-002126-24 (EudraCT Number); jRCT2031210559 (Registry Identifier: Japan Registry for Clincal Trials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study may be made available upon request via the Vivli Center for Global Clinical Research Data Site
• IPD Sharing Time Frame: IPD will be made available upon request within 12 months of posting the study results on ct.gov.
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No