TerminatedNCT05227209Updated Feb 21, 2025Results posted

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 interventional study of SEP-4199 CR in Depressive Episodes, Bipolar I Depression, sponsored by Sumitomo Pharma America, Inc.. Terminated at 69 sites in 3 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-21.

Sponsored by Sumitomo Pharma America, Inc. (part of Sumitomo Pharma Co., Ltd.) · Phase 3, Interventional, and Treatment

Why this study was terminated

Company decided not to move forward with further accrual.

Phase: Phase 3
Study type: Interventional
Enrollment: 64
Allocation: Not applicable
Ages: 18 Years to 65 Years
Sex: All

Study 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. 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

Conditions studied

Depressive Episodes, Bipolar I Depression

Browse trials for

Depression 8,240

Keywords

Depression, Depressive episode, Bipolar, Bipolar 1, Bipolar 1 depression

In context

Depression

8,240 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 64 is below the median of 84 across 6,869 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Sumitomo Pharma America, Inc. is the lead sponsor of 181 studies on the registry; 5 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 21 (64%) have results posted.

First submitted after Sumitomo Pharma America, Inc. became part of Sumitomo Pharma Co., Ltd..

Browse Sumitomo Pharma America, Inc. studies →All Sumitomo Pharma Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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:
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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 64 participants (actual)

Study arms

Experimental
SEP-4199 CR
SEP-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.
Drug: SEP-4199 CR

Interventions

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

What researchers measure

Primary outcomes

Number of Subjects Who Experienced Adverse Events in Study
Incidence of adverse events
Time frame: 12 months
Number of Subjects Who Discontinued Due to Adverse Events
Incidence of adverse events leading to discontinuation
Time frame: 12 months
Number of Subjects Who Experienced Serious Adverse Events in Study
Incidence of Serious Adverse Events
Time frame: 12 months

Secondary outcomes

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.
Time frame: 12 months
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).
Time frame: 12 months

Results

Posted Feb 21, 2025

Participant flow

Participant flow — Overall Study
Milestone	SEP-4199 CR
Started	64
Completed	9
Not completed	55
Withdrew: Adverse event	11
Withdrew: Lost to follow-up	1
Withdrew: Withdrawal by subject	7
Withdrew: Other early termination reason (not listed on crf)	36

Outcome measures

PrimaryNumber of Subjects Who Experienced Adverse Events in Study

Incidence of adverse events

Time frame:: 12 months
Reported as:: Count of participants · Participants

Number of Subjects Who Experienced Adverse Events in Study
Participants	SEP-4199 CR
Number of Subjects Who Experienced Adverse Events in Study	39

PrimaryNumber of Subjects Who Discontinued Due to Adverse Events

Incidence of adverse events leading to discontinuation

Time frame:: 12 months
Reported as:: Count of participants · Participants

Number of Subjects Who Discontinued Due to Adverse Events
Participants	SEP-4199 CR
Number of Subjects Who Discontinued Due to Adverse Events	9

PrimaryNumber of Subjects Who Experienced Serious Adverse Events in Study

Incidence of Serious Adverse Events

Time frame:: 12 months
Reported as:: Count of participants · Participants

Number of Subjects Who Experienced Serious Adverse Events in Study
Participants	SEP-4199 CR
Number of Subjects Who Experienced Serious Adverse Events in Study	3

SecondaryMontgomery-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.

Time frame:: 12 months
Reported as:: Mean · score on a scale

Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Change From Baseline
score on a scale	SEP-4199 CR
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Change From Baseline	-6 ± 12.54

SecondaryClinical 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).

Time frame:: 12 months
Reported as:: Mean · score on a scale

Clinical Global Impression Bipolar Version (CGI-BP-S) Depression Score - Change From Baseline
score on a scale	SEP-4199 CR
Clinical Global Impression Bipolar Version (CGI-BP-S) Depression Score - Change From Baseline	-0.8 ± 1.34

Adverse events

Collected over 12 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
SEP-4199 CR	0/64 (0%)	3/64 (4.7%)	39/64 (60.9%)

Most frequent serious events

Most frequent serious events
Event	SEP-4199 CR
SarcoidosisImmune system disorders	1/64
Psychotic disorderPsychiatric disorders	1/64
Suicide attemptPsychiatric disorders	1/64

Most frequent other events

Most frequent other events
Event	SEP-4199 CR
Blood prolactin increasedInvestigations	20/64
HyperprolactinaemiaEndocrine disorders	6/64
NasopharyngitisInfections and infestations	5/64
Weight increasedInvestigations	5/64
DepressionPsychiatric disorders	4/64
InsomniaPsychiatric disorders	4/64
HeadacheNervous system disorders	4/64
Electrocardiogram QT prolongedInvestigations	4/64

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	SEP-4199 CR
Mean	44.8 ± 12.57

Sex: Female, Male
Sex: Female, Male(Participants)	SEP-4199 CR
Female	40
Male	24

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	SEP-4199 CR
Hispanic or Latino	5
Not Hispanic or Latino	59
Unknown or Not Reported	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	SEP-4199 CR
American Indian or Alaska Native	0
Asian	20
Native Hawaiian or Other Pacific Islander	0
Black or African American	1
White	43
More than one race	0
Unknown or Not Reported	0

Study locations

69 sites

University of Alabama at Birmingham Huntsville Regional Medical Campus
Huntsville, Alabama 35801, United States
Advanced Research Center, Inc.
Anaheim, California 92805, United States
Sun Valley Research Center
Imperial, California 92251, United States
Clinical innovations, Inc.
Riverside, California 92506, United States
Collaborative Neuroscience Research, LLC
Torrance, California 90502, United States
Sarkis Clinical Trials
Gainesville, Florida 32607, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida 32256, United States
Premier Clinical Research Institute, Inc
Miami, Florida 33122, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida 32801, United States
Atlanta Behavioral Research, LLC
Atlanta, Georgia 30338, United States
Psych Atlanta, P.C.
Marietta, Georgia 30060, United States
AMR Conventions Research
Warrenville, Illinois 60555, United States
St. Charles Psychiatric Associates / Midwest Research Group
Saint Charles, Missouri 63304, United States
Alivation Research, LLC
Lincoln, Nebraska 68526, United States
Center for Emotional Fitness
Cherry Hill, New Jersey 08002, United States
Finger Lakes Clinical Research
Rochester, New York 14618, United States
Richmond Behavioral Associates ERG Clinical Research - New York PLLC
Staten Island, New York 10312, United States
New Hope Clinical Research
Charlotte, North Carolina 28211, United States
Quest Therapeutics of Avon Lake
Avon Lake, Ohio 44012, United States
Neuro-Behavioral Clinical Research, Inc
North Canton, Ohio 44720, United States
Sooner Clinical Research
Oklahoma City, Oklahoma 73112, United States
Lehigh Center for Clinical Research, LLC
Allentown, Pennsylvania 18104, United States
Community Clinical Research, Inc.
Austin, Texas 78754, United States
UTHealth Science Center at Houston
Houston, Texas 77054, United States
Family Psychiatry of The Woodlands
The Woodlands, Texas 77381, United States
State Psychiatric Hospital - Kardzhali First Women Department Third Men Department
Kardzhali, 6600, Bulgaria
Medical Center Mentalcare OOD
Plovdiv, 4004, Bulgaria
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, Bulgaria
Mental Health Center - Sofia EOOD
Sofia, 1000, Bulgaria
Medical Center Sveti Naum EOOD
Sofia, 1113, Bulgaria
DCC St. Vrach and St. St. Kuzma and Damian OOD
Sofia, 1408, Bulgaria
Medical Center Hera EOOD
Sofia, 1510, Bulgaria
Medical Center Intermedica OOD
Sofia, 1680, Bulgaria
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, Bulgaria
DCC Mladost-M Varna OOD
Varna, 9020, Bulgaria
Hiro Mental Clinic
Fukuoka, Fukuoka 810-0004, Japan
Shinseikai Kaku Mental Clinic
Fukuoka, Fukuoka 810-0022, Japan
Mental Clinic Sakurazaka
Fukuoka, Fukuoka 810-0023, Japan
Hatakeyama Clinic
Kitakyushu, Fukuoka 802-0064, Japan
Someikai Kanagami Clinic
Kitakyushu-shi, Fukuoka 800-0226, Japan
Kokura Mental Clinic
Kitakyushu-shi, Fukuoka 802-0006, Japan
Hirota Clinic
Kurume-shi, Fukuoka 830-0033, Japan
Shiranui Hospital
Omuta-shi, Fukuoka 836-0004, Japan
Jisenkai Nanko Psychiatric Institute
Shirakawa-shi, Fukushima 961-0021, Japan
Teine Keijinkai Hospital
Sapporo, Hokkaido 006-8555, Japan
Tatsuta Clinic
Kobe, Hyōgo 651-0097, Japan
Cerisier Heart Clinic
Kagoshima, Kagoshima-ken 890-0069, Japan
Musashikosugi J Kokorono Clinic
Kawasaki, Kanagawa 211-0004, Japan
Yutaka Clinic
Sagamihara-shi, Kanagawa 252-0303, Japan
Azamino Mental Clinic
Yokohama, Kanagawa 225-0011, Japan
Yamatenomori Kokorono Clinic
Yokohama, Kanagawa 231-0846, Japan
Satokai Yuge Hospital
Kumamoto, Kumamoto 861-8002, Japan
Shiroma Clinic
Urasoe-shi, Okinawa 901-2102, Japan
Rainbow & Sea Hospital
Karatsu-shi, Saga-ken 847-0031, Japan
Juntendo University Hospital
Bunkyō City, Tokyo-To 113-8431, Japan
Senzoku Psychosomatic Clinic
Meguro-ku, Tokyo-To 152-0012, Japan
Minami-Aoyama Antique Street Clinic
Minatoku, Tokyo-To 107-0062, Japan
Heart Care Ginga Clinic
Nakano, Tokyo-To 164-0012, Japan
Sangenjaya Nakamura Mental Clinic
Setagaya-Ku, Tokyo-To 154-0004, Japan
Sangenjaya Neurology- Psychosomatic Clinic
Setagaya-Ku, Tokyo-To 154-0004, Japan
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo-To 150-8935, Japan
Maynds Tower Mental Clinic
Shibuya-ku, Tokyo-To 151-0053, Japan
Sangubashi Kokorono Clinic
Shibuya-ku, Tokyo-To 151-0053, Japan
Etoh Mental Clinic
Shinagawa-ku, Tokyo-To 141-0021, Japan
Tamaki Clinic
Shinjuku-ku, Tokyo-To 160-0023, Japan
Himorogi Psychiatric Institute
Shinjuku-Ku, Tokyo-To 162-0843, Japan
Uguisudani Mental Clinic
Taito-ku, Tokyo-To 110-0003, Japan
Ohwa Mental Clinic
Toshima-ku, Tokyo-To 170-0002, Japan
Kitaikebukuro Kokoro No Clinic
Toshima-ku, Tokyo-To 170-0011, Japan

References and documents

Study documents

Study protocol · Dec 6, 2022
Statistical analysis plan · Jan 25, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — IPD for this study may be made available upon request via theVivli Center for Global Clinical Reserach Data site

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: IPD will be made available upon request within 12 months of posting the study results on ct.gov.

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.

Data sharing details ↗ · vivli.org

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05227209
Lead sponsor: Sumitomo Pharma America, Inc.
Responsible party: Sponsor
First posted: Feb 7, 2022
Start date: Mar 17, 2022
Primary completion: Nov 17, 2023
Completion: Nov 17, 2023
Results posted: Feb 21, 2025
Last update: Feb 21, 2025

Study contacts

CNS Medical Director

study chair · Sumitomo Pharma America, Inc.

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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