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).

NCT ID: NCT05227209

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-17
• Study Completion Date: 2023-11-17

Brief 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.

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

Depressive Episodes, Bipolar I Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SEP-4199 CR

Intervention Type: DRUG

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

Interventions

SEP-4199 CR

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

Intervention Type: DRUG

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

CNS Medical Director

Role: STUDY_CHAIR

Sumitomo Pharma America, Inc.

Locations

University of Alabama at Birmingham Huntsville Regional Medical Campus

Huntsville, Alabama, United States

Advanced Research Center, Inc.

Anaheim, California, United States

Sun Valley Research Center

Imperial, California, United States

Clinical innovations, Inc.

Riverside, California, United States

Collaborative Neuroscience Research, LLC

Torrance, California, United States

Sarkis Clinical Trials

Gainesville, Florida, United States

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, United States

Premier Clinical Research Institute, Inc

Miami, Florida, United States

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

Atlanta Behavioral Research, LLC

Atlanta, Georgia, United States

Psych Atlanta, P.C.

Marietta, Georgia, United States

AMR Conventions Research

Warrenville, Illinois, United States

St. Charles Psychiatric Associates / Midwest Research Group

Saint Charles, Missouri, United States

Alivation Research, LLC

Lincoln, Nebraska, United States

Center for Emotional Fitness

Cherry Hill, New Jersey, United States

Finger Lakes Clinical Research

Rochester, New York, United States

Richmond Behavioral Associates ERG Clinical Research - New York PLLC

Staten Island, New York, United States

New Hope Clinical Research

Charlotte, North Carolina, United States

Quest Therapeutics of Avon Lake

Avon Lake, Ohio, United States

Neuro-Behavioral Clinical Research, Inc

North Canton, Ohio, United States

Sooner Clinical Research

Oklahoma City, Oklahoma, United States

Lehigh Center for Clinical Research, LLC

Allentown, Pennsylvania, United States

Community Clinical Research, Inc.

Austin, Texas, United States

UTHealth Science Center at Houston

Houston, Texas, United States

Family Psychiatry of The Woodlands

The Woodlands, Texas, United States

State Psychiatric Hospital - Kardzhali First Women Department Third Men Department

Kardzhali, , Bulgaria

Medical Center Mentalcare OOD

Plovdiv, , 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, , Bulgaria

Mental Health Center - Sofia EOOD

Sofia, , Bulgaria

Medical Center Sveti Naum EOOD

Sofia, , Bulgaria

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

Sofia, , Bulgaria

Medical Center Hera EOOD

Sofia, , Bulgaria

Medical Center Intermedica OOD

Sofia, , 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, , Bulgaria

DCC Mladost-M Varna OOD

Varna, , Bulgaria

Hiro Mental Clinic

Fukuoka, Fukuoka, Japan

Shinseikai Kaku Mental Clinic

Fukuoka, Fukuoka, Japan

Mental Clinic Sakurazaka

Fukuoka, Fukuoka, Japan

Hatakeyama Clinic

Kitakyushu, Fukuoka, Japan

Someikai Kanagami Clinic

Kitakyushu-shi, Fukuoka, Japan

Kokura Mental Clinic

Kitakyushu-shi, Fukuoka, Japan

Hirota Clinic

Kurume-shi, Fukuoka, Japan

Shiranui Hospital

Omuta-shi, Fukuoka, Japan

Jisenkai Nanko Psychiatric Institute

Shirakawa-shi, Fukushima, Japan

Teine Keijinkai Hospital

Sapporo, Hokkaido, Japan

Tatsuta Clinic

Kobe, Hyōgo, Japan

Cerisier Heart Clinic

Kagoshima, Kagoshima-ken, Japan

Musashikosugi J Kokorono Clinic

Kawasaki, Kanagawa, Japan

Yutaka Clinic

Sagamihara-shi, Kanagawa, Japan

Azamino Mental Clinic

Yokohama, Kanagawa, Japan

Yamatenomori Kokorono Clinic

Yokohama, Kanagawa, Japan

Satokai Yuge Hospital

Kumamoto, Kumamoto, Japan

Shiroma Clinic

Urasoe-shi, Okinawa, Japan

Rainbow & Sea Hospital

Karatsu-shi, Saga-ken, Japan

Juntendo University Hospital

Bunkyō City, Tokyo-To, Japan

Senzoku Psychosomatic Clinic

Meguro-ku, Tokyo-To, Japan

Minami-Aoyama Antique Street Clinic

Minatoku, Tokyo-To, Japan

Heart Care Ginga Clinic

Nakano, Tokyo-To, Japan

Sangenjaya Nakamura Mental Clinic

Setagaya-Ku, Tokyo-To, Japan

Sangenjaya Neurology- Psychosomatic Clinic

Setagaya-Ku, Tokyo-To, Japan

Japanese Red Cross Medical Center

Shibuya-ku, Tokyo-To, Japan

Maynds Tower Mental Clinic

Shibuya-ku, Tokyo-To, Japan

Sangubashi Kokorono Clinic

Shibuya-ku, Tokyo-To, Japan

Etoh Mental Clinic

Shinagawa-ku, Tokyo-To, Japan

Tamaki Clinic

Shinjuku-ku, Tokyo-To, Japan

Himorogi Psychiatric Institute

Shinjuku-Ku, Tokyo-To, Japan

Uguisudani Mental Clinic

Taito-ku, Tokyo-To, Japan

Ohwa Mental Clinic

Toshima-ku, Tokyo-To, Japan

Kitaikebukuro Kokoro No Clinic

Toshima-ku, Tokyo-To, Japan

Countries

United States; Bulgaria; Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2021-002108-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

jRCT2031220302

Identifier Type: REGISTRY

Identifier Source: secondary_id

SEP380-303

Identifier Type: -

Identifier Source: org_study_id