A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder.
- Conditions
- Depressive Episodes, Bipolar I Depression
- Interventions
- Drug: SEP-4199 CR 200 mgDrug: SEP-4199 CR 400 mgDrug: Placebo
- Registration Number
- NCT05169710
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 83
Inclusion Criteria (not all inclusive):
- 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 (not all inclusive):
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SEP-4199 CR 200 mg SEP-4199 CR 200 mg SEP-4199 CR 200 mg/day SEP-4199 CR 400 mg SEP-4199 CR 400 mg SEP-4199 CR 400 mg/day Placebo Placebo Placebo
- Primary Outcome Measures
Name Time Method Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 6 Weeks 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
- Secondary Outcome Measures
Name Time Method Change From Baseline in Global Severity Assessed by the Clinical Global Impressions Severity: Bipolar Version (CGI-BP-S) Score (Depression) at Week 6 6 Weeks 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.
Trial Locations
- Locations (88)
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.
🇺🇸Orlando, Florida, United States
Premier Clinical Research Institute, Inc.
🇺🇸Miami, Florida, United States
Central Miami Medical Institute
🇺🇸Miami, 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
🇺🇸Saint 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"
🇧🇬Ruse, 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-shi, Fukuoka-Ken, Japan
Shinseikai Kaku Mental Clinic
🇯🇵Fukuoka-Shi, Fukuoka-Ken, Japan
Mental Clinic Sakurazaka
🇯🇵Fukuoka-shi, Fukuoka-Ken, Japan
Someikai Kanagami Clinic
🇯🇵Kitakyushu-shi, Fukuoka-Ken, Japan
Kokura Mental Clinic
🇯🇵Kitakyushu-shi, Fukuoka-Ken, Japan
Hatakeyama Clinic
🇯🇵Kitakyushu, Fukuoka-Ken, Japan
Hirota Clinic
🇯🇵Kurume-shi, Fukuoka-Ken, Japan
Shiranui Hospital
🇯🇵Omuta-shi, Fukuoka-Ken, Japan
Jisenkai Nanko Psychiatric Institute
🇯🇵Shirakawa-shi, Fukushima-Ken, Japan
Teine Keijinkai Hospital
🇯🇵Sapporo-shi, Hokkaido, Japan
Tatsuta Clinic
🇯🇵Kobe-shi, Hyogo-Ken, Japan
Cerisier Heart Clinic
🇯🇵Kagoshima-shi, Kagoshima-Ken, Japan
Musashikosugi J Kokorono Clinic
🇯🇵Kawasaki-shi, Kanagawa-Ken, Japan
Yutaka Clinic
🇯🇵Sagamihara-shi, Kanagawa-Ken, Japan
Azamino Mental Clinic
🇯🇵Yokohama-shi, Kanagawa-Ken, Japan
Yamatenomori Kokorono Clinic
🇯🇵Yokohama-shi, Kanagawa-Ken, Japan
Satokai Yuge Hospital
🇯🇵Kumamoto-shi, Kumamoto-ken, Japan
Akari Clinic
🇯🇵Naha-shi, Okinawa-ken, Japan
Shiroma Clinic
🇯🇵Urasoe-shi, Okinawa-ken, Japan
Rainbow & Sea Hospital
🇯🇵Karatsu-shi, Saga-Ken, Japan
Juntendo University Hospital
🇯🇵Bunkyo-ku, Tokyo-To, Japan
Senzoku Psychosomatic Clinic
🇯🇵Meguro-ku, Tokyo-To, Japan
Minami-Aoyama Antique Street Clinic
🇯🇵Minato-ku, Tokyo-To, Japan
Heart Care Ginga Clinic
🇯🇵Nakano-ku, 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''
🇷🇴Bucuresti, Romania
Sectia Psihiatrie, Centrul de Evaluare si Tratament al Toxicodependentelor pentru Tineri "Sfantul Stelian", Sectia Psihiatrie
🇷🇴Bucuresti, Romania
Spitalul Clinic de Psihiatrie
🇷🇴București, 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
🇷🇴Iasi, Romania
Institutul de Psihiatrie Socola Iasi, Sectia Psihiatrie III Acuti
🇷🇴Iasi, Romania
PsychoLine s. r. o., Psychiatricka ambulancia
🇸🇰Rimavska Sobota, Slovakia
Crystal Comfort s.r.o., Psychiatricka ambulancia
🇸🇰Vranov Nad Topľou, Slovakia