A Clinical Study That Will Measure How Well SEP-363856 Works and How Safe it is in Adults With Generalized Anxiety Disorder

March 25, 2024 updated by: Sumitomo Pharma America, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Estimated)

434

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Recruiting
        • Medical Center Medconsult Pleven Ood
        • Contact:
          • Phone Number: 359 876 333 219
        • Principal Investigator:
          • Mariya Alexandrova-Stoycheva, MD
    • Plovdiv
      • Aleksandar Stamboliyski Blvd.,, Plovdiv, Bulgaria, 4004
        • Recruiting
        • Medical Center Mentalcare OOD 107
        • Contact:
          • Phone Number: 359 878 294 611
        • Principal Investigator:
          • Vasil Kotetarov, MD
      • Makedonia Str., Ground Floor, Plovdiv, Bulgaria, 4004
        • Recruiting
        • Medical Center Spectar - Plovdiv EOOD 107
        • Contact:
          • Phone Number: 359 897 572 151
        • Principal Investigator:
          • Nikolay Popov, MD
    • Sofia
      • Dr. Lyuben Russev Str., Sofia, Bulgaria, 1113
        • Recruiting
        • Medical Center Sveti Naum EOOD 1
        • Contact:
          • Phone Number: 35929702139
        • Principal Investigator:
          • Assen Karadaliev
      • Klisura Str., Fl. 2, Sofia, Bulgaria, 1510
        • Recruiting
        • Medical Center Hera EOOD 20
        • Contact:
          • Spiridon Spiridonov, MD
        • Principal Investigator:
          • Spiridon Spiridonov, MD
      • Nishava Str.,, Sofia, Bulgaria, 1680
        • Recruiting
        • Medical Center Intermedica OOD 62
        • Contact:
          • Phone Number: 359 887 408 242
        • Principal Investigator:
          • Toni Donchev, MD
      • OOD 17, Dimitar Manov Str.,, Sofia, Bulgaria, 1408
        • Recruiting
        • DCC St. Vrach and St. St. Kuzma and Damian
        • Contact:
          • Phone Number: 359 887303241
        • Principal Investigator:
          • Petya Dimitrova, MD
      • Slivnitsa Blvd., Sofia, Bulgaria, 1000
        • Recruiting
        • Mental Health Center - Sofia EOOD 309
        • Contact:
          • Phone Number: 359 887 508 204
        • Principal Investigator:
          • Emil Grashnov, MD
    • Varna
      • Republika Blvd., MC Mladost, 3rd Floor, Varna, Bulgaria, 9020
        • Recruiting
        • DCC Mladost-M Varna OOD 15
        • Contact:
          • Phone Number: 359 888 816 035
        • Principal Investigator:
          • Hristo Kozhuharov, MD
  • Estonia
      • Tallinn, Estonia, 11315
        • Recruiting
        • Marienthali Kliinik Kotka 12
        • Contact:
          • Phone Number: 372 6505036
        • Principal Investigator:
          • Anu Arold
    • Tartu
      • Raja 31, Tartu, Estonia, 50417
        • Recruiting
        • Tartu University Hospital
        • Contact:
          • Innar Tõru
          • Phone Number: 37256696383
        • Principal Investigator:
          • Innar Tõru
  • Finland
      • Helsinki, Finland, 00100
        • Recruiting
        • Mederon Ltd.
        • Contact:
          • Phone Number: 358505933451
        • Principal Investigator:
          • Martti Heikkinen
    • Helsinki
      • Annankatu 32, Helsinki, Finland, 00100
        • Recruiting
        • Lääkärikeskus Aava Kamppi
        • Contact:
          • Phone Number: 358505523185
        • Principal Investigator:
          • Liisa Lahdelma
    • Kuopio
      • Asemakatu 46 B 23, Kuopio, Finland, 70110
        • Recruiting
        • Savon Psykiatripalvelu Oy
        • Contact:
          • Phone Number: 358017 288 2710
        • Principal Investigator:
          • Antti Lepola
    • Oulu
      • Isokatu 8 B 8, Oulu, Finland, 90100
        • Recruiting
        • Oulu Mentalcare Oy
        • Contact:
          • Phone Number: 358408324356
        • Principal Investigator:
          • Markku Timonen
    • Tampere
      • Ltainenkatu, Tampere, Finland, 3 33210
        • Recruiting
        • Satakunnan Psykitaripalvelu Oy at Mehilainen Tampere Finlayson
        • Contact:
          • Phone Number: 358408233255
        • Principal Investigator:
          • Marko Sorvaniemi
  • Japan
    • Fukuoka-Ken
      • Chikugo-shi, Fukuoka-Ken, Japan, 833-0041
        • Recruiting
        • Uematsu Mental Clinic
        • Contact:
          • Uematsu
        • Principal Investigator:
          • Uematsu
      • Fukuoka-Shi, Fukuoka-Ken, Japan, 810-0022
        • Recruiting
        • Shinseikai Kaku Mental Clinic
        • Contact:
          • Kaku
          • Phone Number: +81925253100
      • Fukuoka-shi, Fukuoka-Ken, Japan, 810-0004
        • Recruiting
        • Hiro Mental Clinic
        • Contact:
          • Furui
        • Principal Investigator:
          • Furui
      • Fukuoka-shi, Fukuoka-Ken, Japan, 810-0023
        • Recruiting
        • Mental Clinic Sakurazaka
        • Contact:
          • Watanabe
        • Principal Investigator:
          • Watanabe
      • Kitakyushu-shi, Fukuoka-Ken, Japan, 802-0006
        • Recruiting
        • Kokura Mental Clinic
        • Contact:
          • Hamada
          • Phone Number: +81935518086
      • Kurume-shi, Fukuoka-Ken, Japan, 830-0033
        • Recruiting
        • Hirota Clinic
        • Contact:
          • Hirota
        • Principal Investigator:
          • Hirota
    • Hiroshima-Ken
      • Kure-shi, Hiroshima-Ken, Japan, 737-0111
        • Recruiting
        • Hayakawa Clinic
        • Contact:
          • Hayakawa
        • Principal Investigator:
          • Hayakawa
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 003-0003
        • Recruiting
        • Higashi-Sapporo Mental Clinic
        • Contact:
          • Harada
          • Phone Number: +81118171556
      • Sapporo-shi, Hokkaido, Japan, 062-0922
        • Recruiting
        • Shimode Mental Clinic
        • Contact:
          • Shimode
          • Phone Number: 81118336662
        • Principal Investigator:
          • Shimode
    • Okinawa-Ken
      • Naha-shi, Okinawa-Ken, Japan, 900-0004
        • Recruiting
        • Akari Clinic
        • Contact:
          • Nakamura
          • Phone Number: 81989888864
        • Principal Investigator:
          • Nakamura
      • Urasoe-shi, Okinawa-Ken, Japan, 901-2104
        • Recruiting
        • Barclay Imuro Mental Clinic
        • Contact:
          • Imuro
          • Phone Number: 81988777700
        • Principal Investigator:
          • Imuro
    • Tokyo-To
      • Meguro-ku, Tokyo-To, Japan, 152-0012
        • Recruiting
        • Senzoku Psychosomatic Clinic
        • Contact:
          • Matsushima
      • Setagaya-ku, Tokyo-To, Japan, 154-0004
        • Recruiting
        • Sangenjaya Nakamura Mental Clinic
        • Contact:
          • Nakamura
      • Setagaya-ku, Tokyo-To, Japan, 154-0004
        • Recruiting
        • Sangenjaya Neurology- Psychosomatic Clinic
        • Contact:
          • Shigemori
  • Slovakia
    • Kosice
      • Hlavna 68, Kosice, Slovakia, 040 01
        • Recruiting
        • EPAMED s.r.o.
        • Contact:
          • Phone Number: 421902539617
        • Principal Investigator:
          • Eva Palova, MD
    • Rimavska Sobota
      • Dobsinskeho 4861, Rimavska Sobota, Slovakia, 979 01
        • Recruiting
        • PsychoLine s.r.o.
        • Contact:
          • Phone Number: 421905458236
        • Principal Investigator:
          • Abdul Mohammad Shinwari, MD
    • Ruzinovska
      • Bratislava, Ruzinovska, Slovakia, 10, 820 07
        • Recruiting
        • MENTUM, s.r.o.
        • Contact:
          • Phone Number: 421903442910
        • Principal Investigator:
          • Peter Molcan, MD
    • Vranov Nad Toplou
      • M. R. Stefanika 2427, Vranov Nad Toplou, Slovakia, 093 01
        • Recruiting
        • Crystal Comfort s.r.o.
        • Contact:
          • Dagmar Breznoscakova, MD, PhD.
          • Phone Number: 421918773918
    • Zlaté Moravce
      • Bernolákova 24 953 01, Zlaté Moravce, Slovakia, 953 01
        • Recruiting
        • Bona Medic
        • Contact:
          • Marta Pavlikova, MD
          • Phone Number: 421905390233
        • Principal Investigator:
          • Marta Pavlikova, MD
  • Spain
      • Madrid, Spain, 28031
        • Recruiting
        • Hospital Universitario Infanta Leonor, Dept of Psychiatry C/Gran Vía del
        • Contact:
          • Javier Quintero
          • Phone Number: +34626009755
        • Principal Investigator:
          • Javier Quintero, MD
    • Asturias
      • Langreo, Asturias, Spain, 33920
        • Recruiting
        • Hospital Valle del Nalon
        • Contact:
          • Celso Iglesias, Dr
          • Phone Number: 34697669755
        • Principal Investigator:
          • Celso Iglesias, Dr.
    • C/ De Saint Antoni Maria Claret, 135
      • Barcelona, C/ De Saint Antoni Maria Claret, 135, Spain, 08025
        • Recruiting
        • Institucion Hospitalaria Hestia Palau
        • Contact:
          • Elena R Cucurull
          • Phone Number: 34610219165
        • Principal Investigator:
          • Elena R Cucurull, Dr.
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Recruiting
        • Hospital Universitario Fundacion Alcorcon
        • Contact:
          • Montañes R Francisco
          • Phone Number: +34916219851
        • Principal Investigator:
          • Montañes R Francisco
    • Málaga
      • Avda. Poeta Muñoz Rojas, S/n Antequera, Málaga, Spain, 29200
        • Recruiting
        • Hospital de Antequera
        • Contact:
          • Fontalba Andrés, MD
          • Phone Number: 34670943728
        • Principal Investigator:
          • 34670943728 Andrés, MD
  • Sweden
      • Föreningsgatan 26, Malmö,, Sweden, 211 52
        • Recruiting
        • PharmaSite
        • Contact:
          • Pekka Koskinen
          • Phone Number: 4640971260
        • Principal Investigator:
          • Pekka Koskinen
      • Gothenburgh, Sweden
        • Recruiting
        • Sahlgrenska University Hospita/ Affektiva l, FoU-avdelningen Plan 3, Psykiatri
        • Contact:
          • Phone Number: 46(0)733600850
        • Principal Investigator:
          • Michael Ioannou
      • Lund, Sweden, 222 22
        • Recruiting
        • ProbarE i Lund Lilla Fiskaregatan 10
        • Contact:
          • Phone Number: 46705357869
        • Principal Investigator:
          • Anders Luts
    • Stockholm
      • Vegagatan 8, Stockholm, Sweden, 113 29
        • Recruiting
        • ProbarE
        • Contact:
          • Phone Number: 46723942294
        • Principal Investigator:
          • Peter Bosson
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Recruiting
        • UAB Huntsville Regional Medical Campus
        • Principal Investigator:
          • Richard Shelton
        • Contact:
          • Richard Shelton
          • Phone Number: 256-551-4425
    • California
      • Oceanside, California, United States, 92056
        • Recruiting
        • Excell Research, Inc.
        • Contact:
          • Sherry Soefje
          • Phone Number: 760-758-2222
      • Temecula, California, United States, 92591
        • Recruiting
        • Viking Pharmaceutical Trials Inc. dba Viking Clinical Research
        • Contact:
          • Pamela Alvarez
          • Phone Number: 951-695-6238
      • Torrance, California, United States, 90502
        • Recruiting
        • CenExel Collaborative Neuroscience Research
        • Contact:
          • Lara Shirikjian
          • Phone Number: 310-523-4200
    • Florida
      • Tampa, Florida, United States, 33607
        • Recruiting
        • Olympian Clinical Research
        • Contact:
          • Kelley Yokum
          • Phone Number: 813-725-4020
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Recruiting
        • NeuroTrials Research, Inc.
        • Contact:
          • Matthews W Gwynn, MD
          • Phone Number: 404-851-9934
        • Principal Investigator:
          • Matthews W Gwynn, MD
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Recruiting
        • Uptown Research Institute, LLC
        • Contact:
          • John Sonnenberg
          • Phone Number: 773-989-8313
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Recruiting
        • Boston Clinical Trials
        • Contact:
          • Darin Dougherty
          • Phone Number: 617-477-4868
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08002
        • Recruiting
        • Center for Emotional Fitness
        • Contact:
          • Leon I. Rosenberg
          • Phone Number: 856-857-9500
        • Principal Investigator:
          • Leon I. Rosenberg, MD
    • New York
      • Cedarhurst, New York, United States, 11516
        • Recruiting
        • Neurobehavioral Research, Inc.
        • Contact:
          • Ronald Brenner
          • Phone Number: 516-295-7230
      • New York, New York, United States, 10128
        • Recruiting
        • The Medical Research Network, L.L.C
        • Contact:
          • Jason Careri
          • Phone Number: 212-595-5012
    • Ohio
      • North Canton, Ohio, United States, 44720
        • Recruiting
        • Dr. Shishuka Malhotra
        • Contact:
          • Phone Number: 330-493-1118
        • Principal Investigator:
          • Shishuka Malhotra
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Recruiting
        • Sooner Clinical Research
        • Contact:
          • Veronique Sebastian
          • Phone Number: 405-843-0374
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Recruiting
        • Lehigh Center for Clinical Research, LLC
        • Contact:
          • Paul Gross
          • Phone Number: 610-820-0342
    • Texas
      • Austin, Texas, United States, 78737
        • Recruiting
        • Donald J. Garcia Jr., MD, PA
        • Contact:
          • Donald J. Garcia, Jr., MD
          • Phone Number: 512-521-0595
      • Dallas, Texas, United States, 75231
        • Recruiting
        • FutureSearch Trials of Dallas, LP
        • Contact:
          • Michael Downing
          • Phone Number: 214-369-2600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SEP-363856
dosed once daily tablet
Drug: SEP-363856
once daily tablet
Placebo Comparator: Placebo
dosed once daily tablet
Drug: Placebo
once daily tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Endpoint
Time Frame: Week 8
The HAM-A scale consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point (0-4) scale, with higher scores indicating greater severity.
Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Clinical Global Impression-Severity (CGI-S) score at Endpoint
Time Frame: Week 8
The CGI-S is a clinician-rated assessment of the subject's current illness state on a 7-point scale, where a higher score is associated with greater illness severity.
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sumitomo Pharma America, Inc.

Investigators

  • Study Chair: CNS Medical Director, Sumitomo Pharma America, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2023

Primary Completion (Estimated)

February 8, 2025

Study Completion (Estimated)

February 8, 2025

Study Registration Dates

First Submitted

February 6, 2023

First Submitted That Met QC Criteria

February 6, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEP361-226
  • 2022-502077-42-00 (Other Identifier: EMA)
  • jRCT2031230152 (Registry Identifier: Japan Registry for Clinical Trials (jRCT))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD for this study may be made available upon request via the VivliCenter for Global Clinical Data Research site.

IPD Sharing Time Frame

IPD will be made available upon request within 12 months of posting the study results on ct.gov

IPD Sharing Access Criteria

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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