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Depressive Episodes, Bipolar I DepressionPhase 3NCT05169710

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

A Phase 3 study testing SEP-4199 CR 200 mg and SEP-4199 CR 400 mg in people with Depressive Episodes, Bipolar I Depression, run by Sumitomo Pharma America, Inc. at 89 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
SEP-4199 CR 200 mg and SEP-4199 CR 400 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
83 participants
Where
89 sitesin 6 countries
Study dates
21 Dec 2021to 18 Oct 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

89 sites in 6 countries.

89 sites in 6 countries

Japan35 sites

  • Juntendo University Hospital

    Bunkyō City, Tokyo-To, 113-8431

  • Hiro Mental Clinic

    Fukuoka, Fukuoka, 810-0004

  • Shinseikai Kaku Mental Clinic

    Fukuoka, Fukuoka, 810-0022

  • Mental Clinic Sakurazaka

    Fukuoka, Fukuoka, 810-0023

  • Cerisier Heart Clinic

    Kagoshima, Kagoshima-ken, 890-0069

  • Rainbow & Sea Hospital

    Karatsu-shi, Saga-ken, 847-0031

  • Musashikosugi J Kokorono Clinic

    Kawasaki-shi, Kanagawa, 211-0004

  • Hatakeyama Clinic

    Kitakyushu, Fukuoka, 802-0064

  • Someikai Kanagami Clinic

    Kitakyushu-shi, Fukuoka, 800-0226

  • Kokura Mental Clinic

    Kitakyushu-shi, Fukuoka, 802-0006

  • Tatsuta Clinic

    Kobe, Hyōgo, 651-0097

  • Satokai Yuge Hospital

    Kumamoto, Kumamoto, 861-8002

  • Hirota Clinic

    Kurume-shi, Fukuoka, 830-0033

  • Senzoku Psychosomatic Clinic

    Meguro-ku, Tokyo-To, 152-0012

  • Minami-Aoyama Antique Street Clinic

    Minatoku, Tokyo-To, 107-0062

  • Akari Clinic

    Naha, Okinawa, 900-0004

  • Heart Care Ginga Clinic

    Nakano, Tokyo-To, 164-0012

  • Shiranui Hospital

    Omuta-shi, Fukuoka, 836-0004

  • Yutaka Clinic

    Sagamihara-shi, Kanagawa, 252-0303

  • Teine Keijinkai Hospital

    Sapporo, Hokkaido, 006-8555

  • Sangenjaya Nakamura Mental Clinic

    Setagaya-ku, Tokyo-To, 154-0004

  • Sangenjaya Neurology- Psychosomatic Clinic

    Setagaya-ku, Tokyo-To, 154-0004

  • Japanese Red Cross Medical Center

    Shibuya-ku, Tokyo-To, 150-8935

  • Maynds Tower Mental Clinic

    Shibuya-ku, Tokyo-To, 151-0053

  • Sangubashi Kokorono Clinic

    Shibuya-ku, Tokyo-To, 151-0053

  • Etoh Mental Clinic

    Shinagawa-ku, Tokyo-To, 141-0021

  • Tamaki Clinic

    Shinjuku-ku, Tokyo-To, 160-0023

  • Himorogi Psychiatric Institute

    Shinjuku-ku, Tokyo-To, 162-0843

  • Jisenkai Nanko Psychiatric Institute

    Shirakawa-shi, Fukushima, 961-0021

  • Uguisudani Mental Clinic

    Taito-ku, Tokyo-To, 110-0003

  • Ohwa Mental Clinic

    Toshima-ku, Tokyo-To, 170-0002

  • Kitaikebukuro Kokoro No Clinic

    Toshima-ku, Tokyo-To, 170-0011

  • Shiroma Clinic

    Urasoe-shi, Okinawa, 901-2102

  • Azamino Mental Clinic

    Yokohama, Kanagawa, 225-0011

  • Yamatenomori Kokorono Clinic

    Yokohama, Kanagawa, 231-0846

Other trials in Japan

United States34 sites

  • Lehigh Center for Clinical Research, LLC

    Allentown, Pennsylvania, 18104

  • Advanced Research Center, Inc.

    Anaheim, California, 92805

  • Atlanta Behavioral Research, LLC

    Atlanta, Georgia, 30338

  • Community Clinical Research, Inc.

    Austin, Texas, 78754

  • Quest Therapeutics of Avon Lake

    Avon Lake, Ohio, 44012

  • Sanro Clinical Research Group LLC

    Bryant, Arkansas, 72022

  • UB Department of Psychiatry

    Buffalo, New York, 14215

  • New Hope Clinical Research

    Charlotte, North Carolina, 28211

  • Center for Emotional Fitness

    Cherry Hill, New Jersey, 08002

  • Vertex Research Group

    Clermont, Florida, 34711

  • Sarkis Clinical Trials

    Gainesville, Florida, 32607

  • UTHealth Science Center at Houston

    Houston, Texas, 77054

  • University of Alabama at Birmingham Huntsville Regional Medical Campus

    Huntsville, Alabama, 35801

  • Sun Valley Research Center

    Imperial, California, 92251

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32256

  • Alivation Research, LLC

    Lincoln, Nebraska, 68526

  • Dept. of Psychiatry & Behavioral Sciences, University of Louisville School of Medicine

    Louisville, Kentucky, 40202

  • Psych Atlanta, P.C.

    Marietta, Georgia, 30060

  • Premier Clinical Research Institute, Inc.

    Miami, Florida, 33122

  • Central Miami Medical Institute

    Miami, Florida, 33125

  • Neuro-Behavioral Clinical Research, Inc

    North Canton, Ohio, 44720

  • Sooner Clinical Research

    Oklahoma City, Oklahoma, 73112

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32801

  • Global Medical Institutes, LLC

    Princeton, New Jersey, 08540

  • Clinical innovations, Inc.

    Riverside, California, 92506

  • Finger Lakes Clinical Research

    Rochester, New York, 14618

  • St. Charles Psychiatric Associates / Midwest Research Group

    Saint Charles, Missouri, 63304

  • Siyan Clinical Research

    Santa Rosa, California, 95401

  • Integrated Clinical Research

    St. George, Utah, 84770

  • Richmond Behavioral Associates ERG Clinical Research - New York PLLC

    Staten Island, New York, 10312

  • GCP Clinical Research LLC

    Tampa, Florida, 33609

  • Family Psychiatry of The Woodlands

    The Woodlands, Texas, 77381

  • Collaborative Neuroscience Research, LLC

    Torrance, California, 90502

  • AMR Conventions Research

    Warrenville, Illinois, 60555

Other trials in United States

Bulgaria10 sites

  • State Psychiatric Hospital - Kardzhali First Women Department Third Men Department

    Kardzhali, 6600

  • Medical Center Mentalcare OOD

    Plovdiv, 4004

  • 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"

    Rousse, 7003

  • Mental Health Center - Sofia EOOD

    Sofia, 1000

  • Medical Center Sveti Naum EOOD

    Sofia, 1113

  • DCC St. Vrach and St. St. Kuzma and Damian OOD

    Sofia, 1408

  • Medical Center Hera EOOD

    Sofia, 1510

  • Medical Center Intermedica OOD

    Sofia, 1680

  • 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

    Tsarev Brod, 9747

  • DCC Mladost-M Varna OOD 15, Republika Blvd., MC Mladost, 3rd floor

    Varna, 0920

Other trials in Bulgaria

Romania7 sites

  • Spitalul Clinic de Psihiatrie si Neurologie Brasov, Sectia Psihiatrie Clinică I

    Brasov, 500123

  • Spitalul Clinic de Psihiatrie ''Prof. Dr. Alexandru Obregia''

    Bucharest, 040874

  • Spitalul Clinic de Psihiatrie

    Bucharest, 041914

  • Sectia Psihiatrie, Centrul de Evaluare si Tratament al Toxicodependentelor pentru Tineri "Sfantul Stelian", Sectia Psihiatrie

    Bucharest, 060222

  • Institutul Privat De Cercetări Melchisedec, Pentru Boli Autoimune, Ereditare Şi Rare - I.P.C.M.

    Craiova, 200157

  • Institutul de Psihiatrie Socola Iasi, Sectia Psihiatrie I Femei

    Iași, 700282

  • Institutul de Psihiatrie Socola Iasi, Sectia Psihiatrie III Acuti

    Iași, 700282

Other trials in Romania

Slovakia2 sites

  • PsychoLine s. r. o., Psychiatricka ambulancia

    Rimavská Sobota, 979 01

  • Crystal Comfort s.r.o., Psychiatricka ambulancia

    Vranov nad Topľou, 093 01

Other trials in Slovakia

Canada1 site

  • AMNDX Inc.

    Markham, Ontario, L3R 1A3

Other trials in Canada

About this study

Official title: 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.

Read the 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

Being tested
SEP-4199 CR 200 mg, SEP-4199 CR 400 mg, Placebo
Keywords
Depression, Depressive episode, Bipolar, Bipolar 1, Bipolar 1 depression
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SEP-4199 CR 200 mgDrug

    SEP-4199 CR 200 mg Tablet (supplied in one 200mg tablet and one placebo tablet)

  • SEP-4199 CR 400 mgDrug

    SEP-4199 CR 400 mg tablet (supplied in two 200mg tablets)

  • PlaceboDrug

    Placebo tablet (supplied in two tablets)

Study groups in NCT05169710
Study groupRoleWhat they receive
SEP-4199 CR 200 mgExperimentalSEP-4199 CR 200 mg/day
Receives: Drug: SEP-4199 CR 200 mg
SEP-4199 CR 400 mgExperimentalSEP-4199 CR 400 mg/day
Receives: Drug: SEP-4199 CR 400 mg
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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

    Measured: 6 Weeks

Secondary outcomes (1)

  1. Change From Baseline in Global Severity Assessed by the Clinical Global Impressions Severity: Bipolar Version (CGI-BP-S) Score (Depression) at Week 6

    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.

    Measured: 6 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2021
  2. Study start21 Dec 2021
  3. Primary completion18 Oct 2023
  4. Study completion18 Oct 2023

Why it stopped: Company decided not to move forward with further accrual.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05169710
Sponsor's protocol ID
SEP380-301
Other IDs
2021-002126-24, jRCT2031210559
Status last verified
Sep 2024
First submitted
13 Dec 2021
Last updated
3 Oct 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study may be made available upon request via the Vivli Center for Global Clinical Research Data Site

Publications

  • Hopkins SC, Tomioka S, Szabo ST, Koblan KS. A clinical trial inclusion criteria to enrich for patients presenting with canonical symptom structure in bipolar depression. Contemp Clin Trials. 2024 Oct;145:107644. doi: 10.1016/j.cct.2024.107644. Epub 2024 Aug 3.

    PubMed 39098761

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SEP-4199 CR 200 mg and SEP-4199 CR 400 mg in people with Depressive Episodes, Bipolar I Depression, run by Sumitomo Pharma America, Inc. at 89 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in Japan, United States, Bulgaria, Romania, Slovakia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 (time frame: 6 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05169710, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.

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