Generalized Anxiety Disorder Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 434 |
Est. completion date | February 8, 2025 |
Est. primary completion date | February 8, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Bulgaria | Medical Center Mentalcare OOD 107 | Aleksandar Stamboliyski Blvd., | Plovdiv |
Bulgaria | Medical Center Sveti Naum EOOD 1 | Dr. Lyuben Russev Str. | Sofia |
Bulgaria | Medical Center Hera EOOD 20 | Klisura Str., Fl. 2 | Sofia |
Bulgaria | Medical Center Spectar - Plovdiv EOOD 107 | Makedonia Str., Ground Floor | Plovdiv |
Bulgaria | Medical Center Intermedica OOD 62 | Nishava Str., | Sofia |
Bulgaria | DCC St. Vrach and St. St. Kuzma and Damian | OOD 17, Dimitar Manov Str., | Sofia |
Bulgaria | Medical Center Medconsult Pleven OOD | Pleven | |
Bulgaria | DCC Mladost-M Varna OOD 15 | Republika Blvd., MC Mladost, 3rd Floor | Varna |
Bulgaria | DCC Mladost-M Varna OOD 15 | Republika Blvd., MC Mladost, 3rd Floor | Varna |
Bulgaria | Mental Health Center - Sofia EOOD 309 | Slivnitsa Blvd. | Sofia |
Estonia | Tartu University Hospital | Raja 31 | Tartu |
Estonia | Marienthali Kliinik Kotka 12 | Tallinn | |
Finland | Lääkärikeskus Aava Kamppi | Annankatu 32 | Helsinki |
Finland | Savon Psykiatripalvelu Oy | Asemakatu 46 B 23 | Kuopio |
Finland | Mederon Ltd. | Helsinki | |
Finland | Oulu Mentalcare Oy | Isokatu 8 B 8 | Oulu |
Finland | Satakunnan Psykitaripalvelu Oy at Mehilainen Tampere Finlayson | Ltainenkatu | Tampere |
Japan | Uematsu Mental Clinic | Chikugo-shi | Fukuoka-Ken |
Japan | Hiro Mental Clinic | Fukuoka-shi | Fukuoka-Ken |
Japan | Mental Clinic Sakurazaka | Fukuoka-shi | Fukuoka-Ken |
Japan | Shinseikai Kaku Mental Clinic | Fukuoka-Shi | Fukuoka-Ken |
Japan | Kokura Mental Clinic | Kitakyushu-shi | Fukuoka-Ken |
Japan | Hayakawa Clinic | Kure-shi | Hiroshima-Ken |
Japan | Hirota Clinic | Kurume-shi | Fukuoka-Ken |
Japan | Senzoku Psychosomatic Clinic | Meguro-ku | Tokyo-To |
Japan | Akari Clinic | Naha-shi | Okinawa-Ken |
Japan | Higashi-Sapporo Mental Clinic | Sapporo-shi | Hokkaido |
Japan | Shimode Mental Clinic | Sapporo-shi | Hokkaido |
Japan | Sangenjaya Nakamura Mental Clinic | Setagaya-ku | Tokyo-To |
Japan | Sangenjaya Neurology- Psychosomatic Clinic | Setagaya-ku | Tokyo-To |
Japan | Barclay Imuro Mental Clinic | Urasoe-shi | Okinawa-Ken |
Slovakia | Bona Medic | Bernolákova 24 953 01 | Zlaté Moravce |
Slovakia | MENTUM, s.r.o. | Bratislava | Ruzinovska |
Slovakia | PsychoLine s.r.o. | Dobsinskeho 4861 | Rimavska Sobota |
Slovakia | EPAMED s.r.o. | Hlavna 68 | Kosice |
Slovakia | Crystal Comfort s.r.o. | M. R. Stefanika 2427 | Vranov Nad Toplou |
Spain | Hospital Universitario Fundacion Alcorcón | Alcorcón | Madrid |
Spain | Hospital de Antequera | Avda. Poeta Muñoz Rojas, S/n Antequera | Málaga |
Spain | Institucion Hospitalaria Hestia Palau | Barcelona | C/ De Saint Antoni Maria Claret, 135 |
Spain | Hospital Valle del Nalon | Langreo | Asturias |
Spain | Hospital Universitario Infanta Leonor, Dept of Psychiatry C/Gran Vía del | Madrid | |
Sweden | Pharmasite | Föreningsgatan 26, Malmö, | |
Sweden | Sahlgrenska University Hospita/ Affektiva l, FoU-avdelningen Plan 3, Psykiatri | Gothenburgh | |
Sweden | ProbarE i Lund Lilla Fiskaregatan 10 | Lund | |
Sweden | ProbarE | Vegagatan 8 | Stockholm |
United States | Lehigh Center for Clinical Research, LLC | Allentown | Pennsylvania |
United States | NeuroTrials Research, Inc. | Atlanta | Georgia |
United States | Donald J. Garcia Jr., MD, PA | Austin | Texas |
United States | Boston Clinical Trials | Boston | Massachusetts |
United States | Neurobehavioral Research, Inc. | Cedarhurst | New York |
United States | Center for Emotional Fitness | Cherry Hill | New Jersey |
United States | Uptown Research Institute, LLC | Chicago | Illinois |
United States | FutureSearch Trials of Dallas, LP | Dallas | Texas |
United States | UAB Huntsville Regional Medical Campus | Huntsville | Alabama |
United States | The Medical Research Network, L.L.C | New York | New York |
United States | Dr. Shishuka Malhotra | North Canton | Ohio |
United States | Excell Research, Inc. | Oceanside | California |
United States | Sooner Clinical Research | Oklahoma City | Oklahoma |
United States | Olympian Clinical Research | Tampa | Florida |
United States | Viking Pharmaceutical Trials Inc. dba Viking Clinical Research | Temecula | California |
United States | CenExel Collaborative Neuroscience Research | Torrance | California |
Lead Sponsor | Collaborator |
---|---|
Sumitomo Pharma America, Inc. |
United States, Bulgaria, Estonia, Finland, Japan, Slovakia, Spain, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Week 8 | |
Secondary | 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. | Week 8 |
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