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

Primary Purpose

Generalized Anxiety Disorder

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SEP-363856
Placebo
Sponsored by
Sumitomo Pharma America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Generalized Anxiety Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Excell Research, Inc.Recruiting
  • Viking Pharmaceutical Trials Inc. dba Viking Clinical ResearchRecruiting
  • CenExel Collaborative Neuroscience ResearchRecruiting
  • Central Miami Medical Institute
  • Olympian Clinical ResearchRecruiting
  • NeuroTrials Research, Inc.Recruiting
  • Uptown Research Institute, LLCRecruiting
  • Boston Clinical TrialsRecruiting
  • Center for Emotional FitnessRecruiting
  • Neurobehavioral Research, Inc.Recruiting
  • The Medical Research Network, L.L.CRecruiting
  • Dr. Shishuka Malhotra
  • Sooner Clinical ResearchRecruiting
  • Lehigh Center for Clinical Research, LLCRecruiting
  • Donald J. Garcia Jr., MD, PARecruiting
  • FutureSearch Trials of Dallas, LPRecruiting
  • Medical Center Mentalcare OOD 107Recruiting
  • Medical Center Spectar - Plovdiv EOOD 107Recruiting
  • Medical Center Sveti Naum EOOD 1Recruiting
  • Medical Center Hera EOOD 20Recruiting
  • Medical Center Intermedica OOD 62Recruiting
  • DCC St. Vrach and St. St. Kuzma and DamianRecruiting
  • Mental Health Center - Sofia EOOD 309Recruiting
  • DCC Mladost-M Varna OOD 15Recruiting
  • DCC Mladost-M Varna OOD 15Recruiting
  • Medical Center Medconsult Pleven OODRecruiting
  • Marienthali Kliinik Kotka 12Recruiting
  • Lääkärikeskus Aava KamppiRecruiting
  • Savon Psykiatripalvelu OyRecruiting
  • Oulu Mentalcare OyRecruiting
  • Satakunnan Psykitaripalvelu Oy at Mehilainen Tampere FinlaysonRecruiting
  • Mederon Ltd.
  • Shinseikai Kaku Mental ClinicRecruiting
  • Kokura Mental ClinicRecruiting
  • Higashi-Sapporo Mental ClinicRecruiting
  • Senzoku Psychosomatic ClinicRecruiting
  • Sangenjaya Nakamura Mental ClinicRecruiting
  • Sangenjaya Neurology- Psychosomatic ClinicRecruiting
  • EPAMED s.r.o.Recruiting
  • PsychoLine s.r.o.Recruiting
  • MENTUM, s.r.o.
  • ProbarERecruiting
  • Sahlgrenska University Hospita/ Affektiva l, FoU-avdelningen Plan 3, PsykiatriRecruiting
  • ProbarE i Lund Lilla Fiskaregatan 10Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SEP-363856

Placebo

Arm Description

dosed once daily tablet

dosed once daily tablet

Outcomes

Primary Outcome Measures

Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Endpoint
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.

Secondary Outcome Measures

Change from Baseline in Clinical Global Impression-Severity (CGI-S) score at Endpoint
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.

Full Information

First Posted
February 6, 2023
Last Updated
September 25, 2023
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05729373
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2023 (Actual)
Primary Completion Date
February 8, 2025 (Anticipated)
Study Completion Date
February 8, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
Generalized Anxiety Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Double-blind, Parallel group, Placebo-controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double blind
Allocation
Randomized
Enrollment
434 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SEP-363856
Arm Type
Experimental
Arm Description
dosed once daily tablet
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
dosed once daily tablet
Intervention Type
Drug
Intervention Name(s)
SEP-363856
Intervention Description
once daily tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
once daily tablet
Primary Outcome Measure Information:
Title
Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Endpoint
Description
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.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Change from Baseline in Clinical Global Impression-Severity (CGI-S) score at Endpoint
Description
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.
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CNS Medical Director
Phone
1-866-503-6351
Email
ClinicalTrialDisclosure@sunovion.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CNS Medical Director
Organizational Affiliation
Sumitomo Pharma America, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Excell Research, Inc.
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherry Soefje
Phone
760-758-2222
Facility Name
Viking Pharmaceutical Trials Inc. dba Viking Clinical Research
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Alvarez
Phone
951-695-6238
Facility Name
CenExel Collaborative Neuroscience Research
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lara Shirikjian
Phone
310-523-4200
Facility Name
Central Miami Medical Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonardo Alonso
Phone
305-547-2011
Facility Name
Olympian Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelley Yokum
Phone
813-725-4020
Facility Name
NeuroTrials Research, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Russell Rosenberg
Phone
404-851-9934
Facility Name
Uptown Research Institute, LLC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Sonnenberg
Phone
773-989-8313
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darin Dougherty
Phone
617-477-4868
Facility Name
Center for Emotional Fitness
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leon Rosenberg
Phone
856-857-9500
Facility Name
Neurobehavioral Research, Inc.
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Brenner
Phone
516-295-7230
Facility Name
The Medical Research Network, L.L.C
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Careri
Phone
212-595-5012
Facility Name
Dr. Shishuka Malhotra
City
North Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
330-493-1118
First Name & Middle Initial & Last Name & Degree
Shishuka Malhotra
Facility Name
Sooner Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veronique Sebastian
Phone
405-843-0374
Facility Name
Lehigh Center for Clinical Research, LLC
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Gross
Phone
610-820-0342
Facility Name
Donald J. Garcia Jr., MD, PA
City
Austin
State/Province
Texas
ZIP/Postal Code
78737
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donald J. Garcia, Jr., MD
Phone
512-521-0595
Facility Name
FutureSearch Trials of Dallas, LP
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Downing
Phone
214-369-2600
Facility Name
Medical Center Mentalcare OOD 107
City
Aleksandar Stamboliyski Blvd.,
State/Province
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
Phone
359 878 294 611
First Name & Middle Initial & Last Name & Degree
Vasil Kotetarov, MD
Facility Name
Medical Center Spectar - Plovdiv EOOD 107
City
Makedonia Str., Ground Floor
State/Province
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
Phone
359 897 572 151
First Name & Middle Initial & Last Name & Degree
Nikolay Popov, MD
Facility Name
Medical Center Sveti Naum EOOD 1
City
Dr. Lyuben Russev Str.
State/Province
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
Phone
35929702139
First Name & Middle Initial & Last Name & Degree
Assen Karadaliev
Facility Name
Medical Center Hera EOOD 20
City
Klisura Str., Fl. 2
State/Province
Sofia
ZIP/Postal Code
1510
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Spiridon Spiridonov, MD
First Name & Middle Initial & Last Name & Degree
Spiridon Spiridonov, MD
Facility Name
Medical Center Intermedica OOD 62
City
Nishava Str.,
State/Province
Sofia
ZIP/Postal Code
1680
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
Phone
359 887 408 242
First Name & Middle Initial & Last Name & Degree
Toni Donchev, MD
Facility Name
DCC St. Vrach and St. St. Kuzma and Damian
City
OOD 17, Dimitar Manov Str.,
State/Province
Sofia
ZIP/Postal Code
1408
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
Phone
359 887303241
First Name & Middle Initial & Last Name & Degree
Petya Dimitrova, MD
Facility Name
Mental Health Center - Sofia EOOD 309
City
Slivnitsa Blvd.
State/Province
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
Phone
359 887 508 204
First Name & Middle Initial & Last Name & Degree
Emil Grashnov, MD
Facility Name
DCC Mladost-M Varna OOD 15
City
Republika Blvd., MC Mladost, 3rd Floor
State/Province
Varna
ZIP/Postal Code
9020
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
Phone
359 888 940142
First Name & Middle Initial & Last Name & Degree
Petar Petrov, MD
Facility Name
DCC Mladost-M Varna OOD 15
City
Republika Blvd., MC Mladost, 3rd Floor
State/Province
Varna
ZIP/Postal Code
9020
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
Phone
359 888 816 035
First Name & Middle Initial & Last Name & Degree
Hristo Kozhuharov, MD
Facility Name
Medical Center Medconsult Pleven OOD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
Phone
359 876 333 219
First Name & Middle Initial & Last Name & Degree
Mariya Alexandrova-Stoycheva, MD
Facility Name
Marienthali Kliinik Kotka 12
City
Tallinn
ZIP/Postal Code
11315
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
Phone
372 6505036
First Name & Middle Initial & Last Name & Degree
Anu Arold
Facility Name
Lääkärikeskus Aava Kamppi
City
Annankatu 32
State/Province
Helsinki
ZIP/Postal Code
00100
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
Phone
358505523185
First Name & Middle Initial & Last Name & Degree
Liisa Lahdelma
Facility Name
Savon Psykiatripalvelu Oy
City
Asemakatu 46 B 23
State/Province
Kuopio
ZIP/Postal Code
70110
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
Phone
358017 288 2710
First Name & Middle Initial & Last Name & Degree
Antti Lepola
Facility Name
Oulu Mentalcare Oy
City
Isokatu 8 B 8
State/Province
Oulu
ZIP/Postal Code
90100
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
Phone
358408324356
First Name & Middle Initial & Last Name & Degree
Markku Timonen
Facility Name
Satakunnan Psykitaripalvelu Oy at Mehilainen Tampere Finlayson
City
Ltainenkatu
State/Province
Tampere
ZIP/Postal Code
3 33210
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
Phone
358408233255
First Name & Middle Initial & Last Name & Degree
Marko Sorvaniemi
Facility Name
Mederon Ltd.
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
358505933451
First Name & Middle Initial & Last Name & Degree
Martti Heikkinen
Facility Name
Shinseikai Kaku Mental Clinic
City
Fukuoka-Shi
State/Province
Fukuoka-Ken
ZIP/Postal Code
810-0022
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaku
Phone
+81925253100
Facility Name
Kokura Mental Clinic
City
Kitakyushu-shi
State/Province
Fukuoka-Ken
ZIP/Postal Code
802-0006
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hamada
Phone
+81935518086
Facility Name
Higashi-Sapporo Mental Clinic
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
003-0003
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harada
Phone
+81118171556
Facility Name
Senzoku Psychosomatic Clinic
City
Meguro-ku
State/Province
Tokyo-To
ZIP/Postal Code
152-0012
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matsushima
Facility Name
Sangenjaya Nakamura Mental Clinic
City
Setagaya-ku
State/Province
Tokyo-To
ZIP/Postal Code
154-0004
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nakamura
Facility Name
Sangenjaya Neurology- Psychosomatic Clinic
City
Setagaya-ku
State/Province
Tokyo-To
ZIP/Postal Code
154-0004
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shigemori
Facility Name
EPAMED s.r.o.
City
Hlavna 68
State/Province
Kosice
ZIP/Postal Code
040 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
Phone
421902539617
First Name & Middle Initial & Last Name & Degree
Eva Palova, MD
Facility Name
PsychoLine s.r.o.
City
Dobsinskeho 4861
State/Province
Rimavska Sobota
ZIP/Postal Code
979 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
Phone
421905458236
First Name & Middle Initial & Last Name & Degree
Abdul Mohammad Shinwari, MD
Facility Name
MENTUM, s.r.o.
City
Bratislava
State/Province
Ruzinovska
ZIP/Postal Code
10, 820 07
Country
Slovakia
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
421903442910
First Name & Middle Initial & Last Name & Degree
Peter Molcan, MD
Facility Name
ProbarE
City
Vegagatan 8
State/Province
Stockholm
ZIP/Postal Code
113 29
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
Phone
46723942294
First Name & Middle Initial & Last Name & Degree
Peter Bosson
Facility Name
Sahlgrenska University Hospita/ Affektiva l, FoU-avdelningen Plan 3, Psykiatri
City
Gothenburgh
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
Phone
46(0)733600850
First Name & Middle Initial & Last Name & Degree
Michael Ioannou
Facility Name
ProbarE i Lund Lilla Fiskaregatan 10
City
Lund
ZIP/Postal Code
222 22
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
Phone
46705357869
First Name & Middle Initial & Last Name & Degree
Anders Luts

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://vivli.org

Learn more about this trial

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

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