Clinical trial NCT05729373: A Clinical Study That Will Measure How Well SEP-363856 Works and How Safe it is in Adults With Generalized Anxiety Disorder
Official title: A Phase 2/3, Randomized, Double-blind, Parallel Group, Placebo-controlled, Flexible-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in the Treatment of Adults With Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Generalized Anxiety Disorder
Keywords: Generalized Anxiety Disorder
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-15
Enrollment: 434
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, Parallel group, Placebo-controlled
Primary purpose: TREATMENT

Brief summary: A clinical study that will meaure how well SEP-363856 works and how safe it is in adults with Generalized Anixety Disorder. This study will be accepting both male and female subjects between the ages of 18 years and 65 years old. The study will be held in Approximately 50 global study centers and approximately 15 additional centers for a separate Japan population. Participation in the study can be up to approximately 12 weeks.

Detailed description: This is a multicenter, randomized, double-blind, parallel-group, flexible dose, outpatient study evaluating the efficacy and safety of SEP-363856 flexibly dosed (50 - 75 mg/day) versus placebo over an 8-week Treatment Period in subjects with GAD. This study is projected to randomize approximately 434 subjects to 2 treatment groups (SEP-363856 \[50 - 75 mg/day\] or placebo) in a 1:1 ratio.

Approximately 30 additional subjects (N = 15 per treatment group) are projected to enroll in the Japan Cohort. Treatment assignment will be stratified by country. Study drug will be taken at approximately the same time each evening at bedtime .

Eligibility criteria: Inclusion Criteria: (list is not all inclusive)

* Male or female subject between 18 to 65 years of age.
* Subject meets DSM-5 criteria for a diagnosis of Generalized Anxiety Disorder.
* Subject must be willing and able to comply with the study procedures and visit schedule and must be able to understand and follow verbal and written instructions.

Exclusion Criteria: (list is not all inclusive)

* Subject has DSM-5-based diagnosis of any disorder other than Generalized Anxiety Disorder that was the primary focus of treatment within 12 months before Screening.
* Subjects who report an inadequate response to more than 3 antidepressant treatments
* Subject is at significant risk of harming self or others based on Investigator's judgment.
* Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study.
* Female subject who is pregnant, lactating, or plans to get pregnant during the study.

Primary outcomes:
measure: Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Endpoint
timeFrame: Week 8
Secondary outcomes:
measure: Change from Baseline in Clinical Global Impression-Severity (CGI-S) score at Endpoint
timeFrame: Week 8
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: IMA Clinical Research Phoenix
state: Arizona
city: Culver City
country: United States
facility: ProScience Research Group
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc.
state: California
city: Redlands
country: United States
facility: Anderson Clinical Research
state: California
city: Sherman Oaks
country: United States
facility: Schuster Medical Research Institute
state: California
city: Sherman
country: United States
facility: California Neuroscience Research, LLC
state: California
city: Temecula
country: United States
facility: Viking Pharmaceutical Trials Inc. dba Viking Clinical Research
state: California
city: Torrance
country: United States
facility: CenExel Collaborative Neuroscience Research
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Management Group
state: California
city: Jacksonville
country: United States
facility: CNS Healthcare
state: Florida
city: Orlando
country: United States
facility: Combined Research Orlando
state: Florida
city: Tampa
country: United States
facility: K2 Medical Research, LLC
state: Florida
city: Atlanta
country: United States
facility: CenExel iResearch Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Advanced Discovery Research LLC
state: Georgia
city: Atlanta
country: United States
facility: NeuroTrials Research, Inc.
state: Georgia
city: Savannah
country: United States
facility: CenExel iResearch Savannah
state: Georgia
city: Chicago
country: United States
facility: Uptown Research Institute, LLC
state: Illinois
city: Warrenville
country: United States
facility: American Medical Research, Inc.
state: Illinois
city: Boston
country: United States
facility: Copley Clinical
state: Massachusetts
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Watertown
country: United States
facility: Adams Clinical
state: Massachusetts
city: Saint Charles
country: United States
facility: Midwest Research Group
state: Missouri
city: Cherry Hill
country: United States
facility: Center for Emotional Fitness Site
state: New Jersey
city: Marlton
country: United States
facility: CenExel Hassman Research Institute
state: New Jersey
city: Brooklyn
country: United States
facility: Social Psychiatry Research Institute
state: New York
city: Cedarhurst
country: United States
facility: Neurobehavioral Research, Inc.
state: New York
city: Mount Kisco
country: United States
facility: Bioscience Research, LLC
state: New York
city: New York
country: United States
facility: Berman Clinical
state: New York
city: New York
country: United States
facility: Manhattan Behavioral Medicine
state: New York
city: New York
country: United States
facility: The Medical Research Network, L.L.C
state: New York
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: Oklahoma City
country: United States
facility: Paradigm Research Professionals, LLP
state: Oklahoma
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research, LLC
state: Pennsylvania
city: Austin
country: United States
facility: Psychiatry and Psychotherapy Partners Austin
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LP
state: Texas
city: Draper
country: United States
facility: Cedar Clinical Research, Inc.
state: Utah
city: Sofia
country: Bulgaria
facility: Medical Center Mentalcare OOD
state: Plovdiv
city: Pleven
country: Bulgaria
facility: Medical Center Medconsult Pleven OOD
city: Plovdiv
country: Bulgaria
facility: Medical Center Spectar - Plovdiv EOOD
city: Sofia
country: Bulgaria
facility: MHC - Sofia, EOOD
city: Sofia
country: Bulgaria
facility: Medical Center "Sv.Naum"
city: Sofia
country: Bulgaria
facility: DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OOD
city: Sofia
country: Bulgaria
facility: Medical Center Hera EOOD
city: Sofia
country: Bulgaria
facility: Medical Center Intermedica, OOD
city: Varna
country: Bulgaria
facility: DCC "Mladost M" - Varna, OOD Site #156
city: Varna
country: Bulgaria
facility: DCC "Mladost M" - Varna, OOD Site #157
city: Tallinn
country: Estonia
facility: Marienthali Kliinik
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Kuopio
country: Finland
facility: Savon Psykiatripalvelu Oy
state: Savo
city: Helsinki
country: Finland
facility: Aava Laakarikeskus - Aava Kamppi
city: Helsinki
country: Finland
facility: Mederon Oy
city: Oulu
country: Finland
facility: Oulu Mentalcare Oy
city: Tampere
country: Finland
facility: Satakunnan Psykiatripalvelu
city: Chikugo-shi
country: Japan
facility: Uematsu Mental Clinic
state: Fukuoka-Ken
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: Kokura Mental Clinic
state: Fukuoka-Ken
city: Kurume-shi
country: Japan
facility: Hirota Clinic
state: Fukuoka-Ken
city: Kure-shi
country: Japan
facility: Hayakawa Clinic
state: Hiroshima-Ken
city: Sapporo-shi
country: Japan
facility: Higashi-Sapporo Mental Clinic
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Shimode Mental Clinic
state: Hokkaido
city: Naha-shi
country: Japan
facility: Akari Clinic
state: Okinawa-Ken
city: Urasoe-shi
country: Japan
facility: Barclay Imuro Mental Clinic
state: Okinawa-Ken
city: Meguro-ku
country: Japan
facility: Senzoku Psychosomatic Medicine 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: Bratislava
country: Slovakia
facility: MENTUM, s.r.o.
city: Košice
country: Slovakia
facility: Epamed sro
city: Rimavská Sobota
country: Slovakia
facility: PsychoLine s.r.o.
city: Vranov Nad Topľou
country: Slovakia
facility: Crystal Comfort s.r.o.
city: Zlaté Moravce
country: Slovakia
facility: BONA MEDIC, s.r.o.
city: Langreo
country: Spain
facility: Hospital Valle del Nalon
state: Asturias
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundacion Alcorcon
state: Madrid
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Institucion Hospitalaria Hestia Palau
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Málaga
country: Spain
facility: Hospital de Antequera
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset - Östra sjukhuset
city: Lund
country: Sweden
facility: ProbarE- Lund
city: Malmö
country: Sweden
facility: PharmaSite AB Malmö
city: Stockholm
country: Sweden
facility: ProbarE- Stockholm
Study officials:
References: