Clinical Research Directory
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A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Summary
Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia
Official title: A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
522
Start Date
2025-02-28
Completion Date
2026-10-29
Last Updated
2026-02-18
Healthy Volunteers
No
Conditions
Interventions
SEP-363856
tablet
Placebo
tablet
Locations (60)
Pillar Clinical Research LLC - Bentonville Site # 145
Bentonville, Arkansas, United States
Pillar Clinical Research (Little Rock AR) Site #153
Little Rock, Arkansas, United States
Woodland International Research Group Site #141
Little Rock, Arkansas, United States
Woodland Research Northwest Site # 138
Rogers, Arkansas, United States
Clinical Innovations, Inc. dba CITrials (Bellflower) Site #131
Bellflower, California, United States
ProScience Research Group Site #134
Culver City, California, United States
CenExel CNS - Garden Grove (Collaborative Neuroscience Research) Site #123
Garden Grove, California, United States
Synergy San Diego Site #128
Lemon Grove, California, United States
Catalina Research Institute Site #142
Montclair, California, United States
Clinical Innovations Inc. DBA CITrials (Riverside) Site #151
Riverside, California, United States
Richmond Behavioral Associates LLC Site # 136
Riverside, California, United States
CNRI - San Diego LLC Site # 126
San Diego, California, United States
Schuster Medical Research Institute Site # 130
Sherman Oaks, California, United States
CenExel CNS - Los Alamitos (Collaborative Neuroscience Research) Site #149
Torrance, California, United States
Galiz Research Site #146
Hialeah, Florida, United States
Segal Trials - Larkin Behavioral Health - Inpatient & Early Phase Site #147
Hollywood, Florida, United States
Cenexel RCA (Research Centers of America) Site #124
Hollywood, Florida, United States
Premier Clinical Research Institute - Site #150
Miami, Florida, United States
D & H National Research Centers NC Site #143
Miami, Florida, United States
Innovative Clinical Research, Inc. Site # 125
Miami Lakes, Florida, United States
Health Synergy Clinical Research LLC Site #140
West Palm Beach, Florida, United States
Synexus Clinical Research US Inc - Atlanta Site #148
Atlanta, Georgia, United States
CenExel ACMR (Atlanta Center for Medical Research, LLC) Site #122
Atlanta, Georgia, United States
CenExel IRA (CenExcel iResearch, LLC) Site #132
Decatur, Georgia, United States
Accelerated Clinical Trials in Peachtree Corners GA Site # 127
Peachtree Corners, Georgia, United States
Uptown Research Institute Site # 121
Chicago, Illinois, United States
Pillar Clinical Research LLC (Chicago) Site #144
Chicago, Illinois, United States
Eastern Clinical Research Associates - Site # 156
New Orleans, Louisiana, United States
Cenexel CBH (CBH Health) Site # 129
Gaithersburg, Maryland, United States
Hassman Research Institute, LLC Site #120
Marlton, New Jersey, United States
Neuro-Behavioral Clinical Research Site # 135
Canton, Ohio, United States
Community Clinical Research Inc Site # 133
Austin, Texas, United States
InSite Clinical Research Site #152
DeSoto, Texas, United States
HD Research - Memorial Hermann Surgery Center Memorial Village Site #137
Houston, Texas, United States
Pillar Clinical Research LLC (Richardson, TX) Site #155
Richardson, Texas, United States
Hotei Hospital Site # 183
Konan-shi, Aichi-ken, Japan
Seishinkai Okehazama Hospital Site #162
Toyoake-shi, Aichi-ken, Japan
Seijinkai Seinan Hospital Site # 172
Hachinohe-shi, Aomori, Japan
National Hospital Organization Shimofusa Psychiatric Medical Center Site # 171
Chiba, Chiba, Japan
National Kohnodai Medical Center Site # 174
Ichikawa-shi, Chiba, Japan
Kuramitsu Hospital Site # 164
Fukuoka, Fukuoka, Japan
National Hospital Organization Kokura Medical Center Site # 188
Kokuraminami-ku, Kitakyushu-shi, Fukuoka, Japan
Shiranui Hospital Site # 179
Omuta-shi, Fukuoka, Japan
Hayakawa Clinic Site # 163
Kure, Hiroshima, Japan
NHO Kure Medical Center # 178
Kure-shi, Hiroshima, Japan
Nayoro City General Hospital Site # 173
Nayoro-shi, Hokkaido, Japan
Obihiro Kosei Hospital Site # 175
Obihiro, Hokkaido, Japan
Goryokai Medical Corporation Hospital Site # 168
Sapporo, Hokkaido, Japan
Hatano Kousei Hospital # 190
Hadano-shi, Kanagawa, Japan
Tanzawa Hospital # 187
Hadano-shi, Kanagawa, Japan
Fujimidai Hospital Site # 166
Hiratsuka-shi, Kanagawa, Japan
Yuge Hospital Site # 165
Kumamoto, Kumamoto, Japan
Miyakonojo Shinsei Hospital Site # 167
Miyakonojo-shi, Miyazaki, Japan
Neyagawa Sanatorium Site # 169
Neyagawa, Osaka, Japan
National Hospital Organization Hizen Psychiatric Medical Center Site # 177
Kanzaki-gun, Saga-ken, Japan
Rainbow and Sea Hospital Site # 170
Karatsu-shi, Saga-ken, Japan
Tochigi Prefectural Okamotodai Hospital Site # 189
Utsunomiya, Tochigi, Japan
Asuka Hospital Site # 161
Machida-shi, Tokyo, Japan
Showa Medical University Karasuyama Hospital Site # 180
Setagaya-ku, Tokyo, Japan
Yamagata Sakuracho Hospital Site # 176
Yamagata, Yamagata, Japan