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Depressive Episodes, Bipolar I DepressionPhase 3NCT05227209

A Clinical Trial to Determine the Long-term Safety and Tolerability of an Investigational Drug in People With Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression).

A Phase 3 study testing SEP-4199 CR in people with Depressive Episodes, Bipolar I Depression, run by Sumitomo Pharma America, Inc. at 69 sites in 3 countries.

Terminated

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

Official record
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Trial summary

This is a clinical trial to determine the long-term safety and tolerability of an investigational drug in people with Major Depressive Episode Associated with Bipolar I Disorder (Bipolar I Depression). Participants in the study will receive the drug being studied. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
SEP-4199 CR
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
69 sitesin 3 countries
Study dates
17 Mar 2022to 17 Nov 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 has completed 6 weeks of double-blind treatment and all scheduled assessments from Visit 6/EOT (Day 42) of the lead-in study of SEP-4199 CR.
  • Subject is medically appropriate for long-term open-label treatment with SEP-4199 CR in the opinion of the Investigator.
  • Female subjects of childbearing potential must agree to use effective and reliable contraception throughout the study and for at least 30 days after the last dose of study drug has been taken. In the Investigator's judgment, the subject will adhere to this requirement.
  • Male subjects agree to avoid fathering a child and to use effective methods of birth control throughout the study and until at least 90 days after the last study drug administration.

Who cannot join

  • Subject is at high risk of non-compliance in the opinion of the Investigator.
  • Subject plans to initiate treatment with a prohibited psychotropic medication during the study.
  • Subject plans to initiate treatment with transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), vagus nerve stimulation (VNS), or deep brain stimulation (DBS) during the study.
  • Subject experienced a moderate or severe hyperprolactinemia-related AESI in the lead-in study of SEP-4199 CR.
  • Subject will require treatment with a drug that is associated with increases in QTc interval.
  • Subject had any of the following at Visit 6/EOT (Day 42) of the lead-in study of SEP-4199 CR based on machine reading:
Show all 13Show fewer
  • increase in QTcF interval of ≥ 30 msec AND a QTcF interval ≥ 480 msec, from baseline of the lead-in study of SEP-4199 CR AND a QTCF interval ≥ 480msec
  • increase in QTcF interval ≥ 60 msec, from baseline of the lead-in study of SEP-4199 CR
  • QTcF interval ≥ 500 msec
  • treatment-emergent clinically significant ECG abnormality.
  • Subject is considered by the Investigator to be at imminent risk of suicide or injury to self or others, has a MADRS item 10 (suicidal ideation) score ≥ 4, or answers "yes" to "suicidal ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at Visit 6/EOT (Day 42) of the lead-in study of SEP-4199 CR.
  • Female subject of childbearing potential, has a positive urine pregnancy test at Visit 6/EOT (Day 42) of the lead-in study of SEP-4199 CR or plans to become pregnant during the current study.
  • Subject tests positive for any drug of abuse or cannabis at Visit 6/EOT (Day 42) of the lead-in study of SEP-4199 CR

Trial locations and contacts

69 sites in 3 countries.

69 sites in 3 countries

Japan34 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, 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

  • 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 States25 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

  • New Hope Clinical Research

    Charlotte, North Carolina, 28211

  • Center for Emotional Fitness

    Cherry Hill, New Jersey, 08002

  • 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

  • Psych Atlanta, P.C.

    Marietta, Georgia, 30060

  • Premier Clinical Research Institute, Inc

    Miami, Florida, 33122

  • Neuro-Behavioral Clinical Research, Inc

    North Canton, Ohio, 44720

  • Sooner Clinical Research

    Oklahoma City, Oklahoma, 73112

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32801

  • 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

  • Richmond Behavioral Associates ERG Clinical Research - New York PLLC

    Staten Island, New York, 10312

  • 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

    Tsarevo, 9747

  • DCC Mladost-M Varna OOD

    Varna, 9020

Other trials in Bulgaria

About this study

Official title: A 12-Month Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Effectiveness of SEP-4199 Controlled Release (CR) for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression)

This is a clinical trial to determine the long-term safety and tolerability of an investigational drug in people with Major Depressive Episode Associated with Bipolar I Disorder (Bipolar I Depression). Participants in the study will receive the drug being studied. This study is accepting male and female participants between 18 and 65 years old who have completed Study SEP380-301. This study will be conducted in approximately 90 study centers worldwide. The treatment duration for this study is one (1) year.

Read the detailed description

This is a 12-month open-label safety extension study to evaluate the long-term safety, tolerability, and effectiveness of SEP-4199 CR 200-400 mg/day in the treatment of subjects with bipolar I depression who previously completed a lead-in study of SEP-4199 CR.

The study will consist of a 12-month open-label flexible-dose treatment period, and a safety follow-up period. There are 15 scheduled visits, including a Baseline visit, 13 visits during the open-label treatment period, and 1 safety follow-up visit 7 (± 2) days after the last dose of study drug. If necessary, subjects may return to the clinic at anytime for an unscheduled visit

Being tested
SEP-4199 CR
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 CRDrug

    SEP-4199 CR either 200 mg (one 200 mg tablet) or 400 mg (two 200 mg tablets) once daily

Study groups in NCT05227209
Study groupRoleWhat they receive
SEP-4199 CRExperimentalSEP-4199 CR either 200 mg (one 200 mg tablet) or 400 mg (two 200 mg tablets) once daily during open-label flexible-dose treatment period.
Receives: Drug: SEP-4199 CR

What is being measured

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

  1. Number of Subjects Who Experienced Adverse Events in Study

    Incidence of adverse events

    Measured: 12 months

  2. Number of Subjects Who Discontinued Due to Adverse Events

    Incidence of adverse events leading to discontinuation

    Measured: 12 months

  3. Number of Subjects Who Experienced Serious Adverse Events in Study

    Incidence of Serious Adverse Events

    Measured: 12 months

Secondary outcomes (2)

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

    Open Label (OL) Month 12 (LOCF) is defined as the last non-missing post-OL Baseline measurement up to and including the OL Month 12 measurement and within 9 days post the last dose of open-label extension study medication. The 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 and total score range is of 0 to 60 with higher scores indicating increased depressive symptoms.Individual items are then summed to determine total score.

    Measured: 12 months

  2. Clinical Global Impression Bipolar Version (CGI-BP-S) Depression Score - Change From Baseline

    Open Label (OL) Month 12 (LOCF) is defined as the last non-missing post-OL Baseline measurement up to and including the OL Month 12 measurement and within 9 days post the last dose of open-label extension study medication.The Clinical Global Impression Bipolar Version (CGI-BP-S) scale is a 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. Depression Score is one the individual item on CGI-BP-S Scale.The CGI-BP-S depression score takes one of the following values: 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 patients).

    Measured: 12 months

Timeline

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

  1. First posted7 Feb 2022
  2. Study start17 Mar 2022
  3. Primary completion17 Nov 2023
  4. Study completion17 Nov 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
Not applicable
Intervention model
Single group
Model description
This is a 12-month open-label safety extension study to evaluate the long-term safety, tolerability, and effectiveness of SEP-4199 CR 200-400 mg/day in the treatment of subjects with bipolar I depression who previously completed a lead-in study of SEP-4199 CR.The study will consist of a 12-month open-label flexible-dose treatment period, and a safety follow-up period
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05227209
Sponsor's protocol ID
SEP380-303
Other IDs
2021-002108-11, jRCT2031220302
Status last verified
Feb 2025
First submitted
27 Jan 2022
Last updated
21 Feb 2025
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 theVivli Center for Global Clinical Reserach Data site

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SEP-4199 CR in people with Depressive Episodes, Bipolar I Depression, run by Sumitomo Pharma America, Inc. at 69 sites in 3 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 5 inclusion and 13 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 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in Japan, United States, Bulgaria. 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. 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 21 Feb 2025). 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?

Number of Subjects Who Experienced Adverse Events in Study (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT05227209.

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 21 Feb 2025.

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