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

NCT ID: NCT05169710

Last Updated: 2024-10-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-21
• Study Completion Date: 2023-10-18

Brief 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. 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.

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

Conditions

Depressive Episodes, Bipolar I Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SEP-4199 CR 200 mg

SEP-4199 CR 200 mg/day

Group Type: EXPERIMENTAL

SEP-4199 CR 200 mg

Intervention Type: DRUG

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

SEP-4199 CR 400 mg

SEP-4199 CR 400 mg/day

Group Type: EXPERIMENTAL

SEP-4199 CR 400 mg

Intervention Type: DRUG

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

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablet (supplied in two tablets)

Interventions

SEP-4199 CR 200 mg

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

Intervention Type: DRUG

SEP-4199 CR 400 mg

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

Intervention Type: DRUG

Placebo

Placebo tablet (supplied in two tablets)

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 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

• 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.

• 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

Sanro Clinical Research Group LLC

Bryant, Arkansas, 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

Siyan Clinical Research

Santa Rosa, California, United States

Collaborative Neuroscience Research, LLC

Torrance, California, United States

Vertex Research Group

Clermont, Florida, 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

Central Miami Medical Institute

Miami, Florida, United States

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

GCP Clinical Research LLC

Tampa, 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

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

Louisville, Kentucky, 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

Global Medical Institutes, LLC

Princeton, New Jersey, United States

UB Department of Psychiatry

Buffalo, New York, 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

Integrated Clinical Research

St. George, Utah, 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

Tsarev Brod, , Bulgaria

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

Varna, , Bulgaria

AMNDX Inc.

Markham, Ontario, Canada

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-shi, 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

Akari Clinic

Naha, Okinawa, 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

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

Brasov, , Romania

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

Bucharest, , Romania

Spitalul Clinic de Psihiatrie

Bucharest, , Romania

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

Bucharest, , Romania

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

Craiova, , Romania

Institutul de Psihiatrie Socola Iasi, Sectia Psihiatrie I Femei

Iași, , Romania

Institutul de Psihiatrie Socola Iasi, Sectia Psihiatrie III Acuti

Iași, , Romania

PsychoLine s. r. o., Psychiatricka ambulancia

Rimavská Sobota, , Slovakia

Crystal Comfort s.r.o., Psychiatricka ambulancia

Vranov nad Topľou, , Slovakia

Countries

United States; Bulgaria; Canada; Japan; Romania; Slovakia

References

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.

Reference Type: DERIVED

PMID: 39098761 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2021-002126-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

jRCT2031210559

Identifier Type: REGISTRY

Identifier Source: secondary_id

SEP380-301

Identifier Type: -

Identifier Source: org_study_id