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

September 18, 2024 updated by: Sumitomo Pharma America, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
83

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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"
      • 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
      • 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
      • 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, Fukuoka-Ken, Japan, 802-0064
        • Hatakeyama Clinic
      • Kitakyushu-shi, Fukuoka-Ken, Japan, 800-0226
        • Someikai Kanagami Clinic
      • Kitakyushu-shi, Fukuoka-Ken, Japan, 802-0006
        • Kokura Mental 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 Nad Topľou, 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6
Time Frame: 6 Weeks
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 ranging from 0 to 6. The MADRS total score ranges from 0 to 60, with higher scores indicating increased depressive symptoms
6 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Global Severity Assessed by the Clinical Global Impressions Severity: Bipolar Version (CGI-BP-S) Score (Depression) at Week 6
Time Frame: 6 Weeks
Clinical Global Impressions Severity: Bipolar Version (CGI-BP-S) score (depression) is a single value, clinician-rated assessment of illness severity, and 7-point scale with range from 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill subjects. A higher score is associated with greater illness severity.
6 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sumitomo Pharma America, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: CNS Medical Director, Sumitomo Pharma America, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 21, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 18, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 18, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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