Clinical trial NCT05227209: 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).
Official title: A 12-Month Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Effectiveness of 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: 2022-02-07
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model 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
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Number of Subjects Who Experienced Adverse Events in Study
timeFrame: 12 months
measure: Number of Subjects Who Discontinued Due to Adverse Events
timeFrame: 12 months
measure: Number of Subjects Who Experienced Serious Adverse Events in Study
timeFrame: 12 months
Secondary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Change From Baseline
timeFrame: 12 months
measure: Clinical Global Impression Bipolar Version (CGI-BP-S) Depression Score - Change From Baseline
timeFrame: 12 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: University of Alabama at Birmingham Huntsville Regional Medical Campus
state: Alabama
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: Torrance
country: United States
facility: Collaborative Neuroscience Research, LLC
state: California
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: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
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: 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: 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: 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: Tsarevo
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
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
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: Urasoe-shi
country: Japan
facility: Shiroma Clinic
state: Okinawa-ken
city: Karatsu-shi
country: Japan
facility: Rainbow & Sea Hospital
state: Saga-Ken
city: Bunkyō-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
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: CNS Medical Director
role: STUDY_CHAIR
References: