Clinical trial NCT05169710: A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder.
Official title: A Multi-region, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating SEP-4199 Controlled Release (CR) for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Depressive Episodes, Bipolar I Depression
Keywords: Depression, Depressive episode, Bipolar, Bipolar 1, Bipolar 1 depression
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2021-12-27
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

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:

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.

Primary outcomes:
measure: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6
timeFrame: 6 Weeks
Secondary outcomes:
measure: Change From Baseline in Global Severity Assessed by the Clinical Global Impressions Severity: Bipolar Version (CGI-BP-S) Score (Depression) at Week 6
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: University of Alabama at Birmingham Huntsville Regional Medical Campus
state: Alabama
city: Bryant
country: United States
facility: Sanro Clinical Research Group LLC
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Research Center, Inc.
state: California
city: Imperial
country: United States
facility: Sun Valley Research Center
state: California
city: Riverside
country: United States
facility: Clinical innovations, Inc.
state: California
city: Santa Rosa
country: United States
facility: Siyan Clinical Research
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Research, LLC
state: California
city: Clermont
country: United States
facility: Vertex Research Group
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Miami
country: United States
facility: Premier Clinical Research Institute, Inc.
state: Florida
city: Miami
country: United States
facility: Central Miami Medical Institute
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Tampa
country: United States
facility: GCP Clinical Research LLC
state: Florida
city: Atlanta
country: United States
facility: Atlanta Behavioral Research, LLC
state: Georgia
city: Marietta
country: United States
facility: Psych Atlanta, P.C.
state: Georgia
city: Warrenville
country: United States
facility: AMR Conventions Research
state: Illinois
city: Louisville
country: United States
facility: Dept. of Psychiatry & Behavioral Sciences, University of Louisville School of Medicine
state: Kentucky
city: Saint Charles
country: United States
facility: St. Charles Psychiatric Associates / Midwest Research Group
state: Missouri
city: Lincoln
country: United States
facility: Alivation Research, LLC
state: Nebraska
city: Cherry Hill
country: United States
facility: Center for Emotional Fitness
state: New Jersey
city: Princeton
country: United States
facility: Global Medical Institutes, LLC
state: New Jersey
city: Buffalo
country: United States
facility: UB Department of Psychiatry
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates ERG Clinical Research - New York PLLC
state: New York
city: Charlotte
country: United States
facility: New Hope Clinical Research
state: North Carolina
city: Avon Lake
country: United States
facility: Quest Therapeutics of Avon Lake
state: Ohio
city: North Canton
country: United States
facility: Neuro-Behavioral Clinical Research, Inc
state: Ohio
city: Oklahoma City
country: United States
facility: Sooner Clinical Research
state: Oklahoma
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research, LLC
state: Pennsylvania
city: Austin
country: United States
facility: Community Clinical Research, Inc.
state: Texas
city: Houston
country: United States
facility: UTHealth Science Center at Houston
state: Texas
city: The Woodlands
country: United States
facility: Family Psychiatry of The Woodlands
state: Texas
city: Saint George
country: United States
facility: Integrated Clinical Research
state: Utah
city: Kardzhali
country: Bulgaria
facility: State Psychiatric Hospital - Kardzhali First Women Department Third Men Department
city: Plovdiv
country: Bulgaria
facility: Medical Center Mentalcare OOD
city: Ruse
country: Bulgaria
facility: 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"
city: Sofia
country: Bulgaria
facility: Mental Health Center - Sofia EOOD
city: Sofia
country: Bulgaria
facility: Medical Center Sveti Naum EOOD
city: Sofia
country: Bulgaria
facility: DCC St. Vrach and St. St. Kuzma and Damian OOD
city: Sofia
country: Bulgaria
facility: Medical Center Hera EOOD
city: Sofia
country: Bulgaria
facility: Medical Center Intermedica OOD
city: Tsarev Brod
country: Bulgaria
facility: 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
city: Varna
country: Bulgaria
facility: DCC Mladost-M Varna OOD 15, Republika Blvd., MC Mladost, 3rd floor
city: Markham
country: Canada
facility: AMNDX Inc.
state: Ontario
city: Fukuoka-shi
country: Japan
facility: Hiro Mental Clinic
state: Fukuoka-Ken
city: Fukuoka-Shi
country: Japan
facility: Shinseikai Kaku Mental Clinic
state: Fukuoka-Ken
city: Fukuoka-shi
country: Japan
facility: Mental Clinic Sakurazaka
state: Fukuoka-Ken
city: Kitakyushu-shi
country: Japan
facility: Someikai Kanagami Clinic
state: Fukuoka-Ken
city: Kitakyushu-shi
country: Japan
facility: Kokura Mental Clinic
state: Fukuoka-Ken
city: Kitakyushu
country: Japan
facility: Hatakeyama Clinic
state: Fukuoka-Ken
city: Kurume-shi
country: Japan
facility: Hirota Clinic
state: Fukuoka-Ken
city: Omuta-shi
country: Japan
facility: Shiranui Hospital
state: Fukuoka-Ken
city: Shirakawa-shi
country: Japan
facility: Jisenkai Nanko Psychiatric Institute
state: Fukushima-Ken
city: Sapporo-shi
country: Japan
facility: Teine Keijinkai Hospital
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Tatsuta Clinic
state: Hyogo-Ken
city: Kagoshima-shi
country: Japan
facility: Cerisier Heart Clinic
state: Kagoshima-Ken
city: Kawasaki-shi
country: Japan
facility: Musashikosugi J Kokorono Clinic
state: Kanagawa-Ken
city: Sagamihara-shi
country: Japan
facility: Yutaka Clinic
state: Kanagawa-Ken
city: Yokohama-shi
country: Japan
facility: Azamino Mental Clinic
state: Kanagawa-Ken
city: Yokohama-shi
country: Japan
facility: Yamatenomori Kokorono Clinic
state: Kanagawa-Ken
city: Kumamoto-shi
country: Japan
facility: Satokai Yuge Hospital
state: Kumamoto-ken
city: Naha-shi
country: Japan
facility: Akari Clinic
state: Okinawa-ken
city: Urasoe-shi
country: Japan
facility: Shiroma Clinic
state: Okinawa-ken
city: Karatsu-shi
country: Japan
facility: Rainbow & Sea Hospital
state: Saga-Ken
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo-To
city: Meguro-ku
country: Japan
facility: Senzoku Psychosomatic Clinic
state: Tokyo-To
city: Minato-ku
country: Japan
facility: Minami-Aoyama Antique Street Clinic
state: Tokyo-To
city: Nakano-ku
country: Japan
facility: Heart Care Ginga Clinic
state: Tokyo-To
city: Setagaya-ku
country: Japan
facility: Sangenjaya Nakamura Mental Clinic
state: Tokyo-To
city: Setagaya-ku
country: Japan
facility: Sangenjaya Neurology- Psychosomatic Clinic
state: Tokyo-To
city: Shibuya-ku
country: Japan
facility: Japanese Red Cross Medical Center
state: Tokyo-To
city: Shibuya-ku
country: Japan
facility: Maynds Tower Mental Clinic
state: Tokyo-To
city: Shibuya-ku
country: Japan
facility: Sangubashi Kokorono Clinic
state: Tokyo-To
city: Shinagawa-ku
country: Japan
facility: Etoh Mental Clinic
state: Tokyo-To
city: Shinjuku-ku
country: Japan
facility: Tamaki Clinic
state: Tokyo-To
city: Shinjuku-ku
country: Japan
facility: Himorogi Psychiatric Institute
state: Tokyo-To
city: Taito-ku
country: Japan
facility: Uguisudani Mental Clinic
state: Tokyo-To
city: Toshima-ku
country: Japan
facility: Ohwa Mental Clinic
state: Tokyo-To
city: Toshima-ku
country: Japan
facility: Kitaikebukuro Kokoro No Clinic
state: Tokyo-To
city: Brasov
country: Romania
facility: Spitalul Clinic de Psihiatrie si Neurologie Brasov, Sectia Psihiatrie Clinică I
city: Bucuresti
country: Romania
facility: Spitalul Clinic de Psihiatrie ''Prof. Dr. Alexandru Obregia''
city: Bucuresti
country: Romania
facility: Sectia Psihiatrie, Centrul de Evaluare si Tratament al Toxicodependentelor pentru Tineri "Sfantul Stelian", Sectia Psihiatrie
city: București
country: Romania
facility: Spitalul Clinic de Psihiatrie
city: Craiova
country: Romania
facility: Institutul Privat De Cercetări Melchisedec, Pentru Boli Autoimune, Ereditare Şi Rare - I.P.C.M.
city: Iasi
country: Romania
facility: Institutul de Psihiatrie Socola Iasi, Sectia Psihiatrie I Femei
city: Iasi
country: Romania
facility: Institutul de Psihiatrie Socola Iasi, Sectia Psihiatrie III Acuti
city: Rimavska Sobota
country: Slovakia
facility: PsychoLine s. r. o., Psychiatricka ambulancia
city: Vranov Nad Topľou
country: Slovakia
facility: Crystal Comfort s.r.o., Psychiatricka ambulancia
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: CNS Medical Director
role: STUDY_CHAIR
References: