A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia
Recruiting · NCT06894212 · Interventional (participants receive a specific treatment) · Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboSEP-363856
What this trial is about
Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Male or female participants between 18 to 65 years of age (inclusive) at the time of consent.
- Participant has an identified reliable informant (eg, caregiver, relative, friend, case worker, residential treatment staff).
- Participant is experiencing an acute exacerbation or relapse of symptoms, with onset ≤ 2 months prior to screening
- The participant requires hospitalization for this acute exacerbation or relapse of symptoms.
- If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening.
- Participants who are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by meeting ALL of the following criteria at the screening and baseline visits:
- Participant must have a PANSS total score ≥ 80
- AND
- Participant must have a CGI-S score ≥ 4.
- Participants who have received previous outpatient antipsychotic treatment at an adequate dose (minimal recommended dose for the treatment of schizophrenia according to the manufacturer labeling) for an adequate duration (at least 6 weeks) and who showed a previous good response.
- Key
Exclusion criteria
- Sexually active participants or persons of childbearing potential who do not agree to practice 2 different clinical trial sponsor approved methods of birth control or remain abstinent during the course of the trial and for 30 days after the last dose of study drug.
- Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia.
- Participant has had psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days prior to screening.
- Participant has previously received SEP-363856 or was previously enrolled in a SEP-363856 clinical study
Where it is running
60 locations listed across 10 US states.
- Pillar Clinical Research LLC - Bentonville Site - Bentonville, Arkansas, United States
- Pillar Clinical Research (Little Rock AR) Site - Little Rock, Arkansas, United States
- Woodland International Research Group Site - Little Rock, Arkansas, United States
- Woodland Research Northwest Site - Rogers, Arkansas, United States
- Clinical Innovations, Inc. dba CITrials (Bellflower) - Bellflower, California, United States
- ProScience Research Group Site - Culver City, California, United States
- CenExel CNS - Garden Grove (Collaborative Neuroscience Research) Site - Garden Grove, California, United States
- Synergy San Diego Site - Lemon Grove, California, United States
- Catalina Research Institute Site - Montclair, California, United States
- Clinical Innovations Inc. DBA CITrials (Riverside) - Riverside, California, United States
- Richmond Behavioral Associates LLC - Riverside, California, United States
- CNRI - San Diego LLC Site - San Diego, California, United States
- Schuster Medical Research Institute - Sherman Oaks, California, United States
- CenExel CNS - Los Alamitos (Collaborative Neuroscience Research) - Torrance, California, United States
- Galiz Research Site - Hialeah, Florida, United States
- Segal Trials - Larkin Behavioral Health - Inpatient & Early Phase Site - Hollywood, Florida, United States
- Cenexel RCA (Research Centers of America) Site - Hollywood, Florida, United States
- Premier Clinical Research Institute - Miami, Florida, United States
- D & H National Research Centers NC - Miami, Florida, United States
- Innovative Clinical Research, Inc. Site - Miami Lakes, Florida, United States
- Health Synergy Clinical Research LLC Site - West Palm Beach, Florida, United States
- Synexus Clinical Research US Inc - Atlanta - Atlanta, Georgia, United States
- CenExel ACMR (Atlanta Center for Medical Research, LLC) Site - Atlanta, Georgia, United States
- CenExel IRA (CenExcel iResearch, LLC) Site - Decatur, Georgia, United States
- Accelerated Clinical Trials in Peachtree Corners GA Site - Peachtree Corners, Georgia, United States
- Uptown Research Institute - Chicago, Illinois, United States
- Pillar Clinical Research LLC (Chicago) - Chicago, Illinois, United States
- Eastern Clinical Research Associates - New Orleans, Louisiana, United States
- Cenexel CBH (CBH Health) - Gaithersburg, Maryland, United States
- Hassman Research Institute, LLC - Marlton, New Jersey, United States
- Neuro-Behavioral Clinical Research Site - North Canton, Ohio, United States
- Community Clinical Research Inc - Austin, Texas, United States
- InSite Clinical Research - DeSoto, Texas, United States
- HD Research - Memorial Hermann Surgery Center Memorial Village - Houston, Texas, United States
- Pillar Clinical Research LLC (Richardson, TX) Site - Richardson, Texas, United States
- Wakayama Medical University Hospital - Wakayama, Japan
- Hotei Hospital - Konan-shi, Aichi-ken, Japan
- Seishinkai Okehazama Hospital - Toyoake-shi, Aichi-ken, Japan
- Seijinkai Seinan Hospital - Hachinohe-shi, Aomori, Japan
- National Hospital Organization Shimofusa Psychiatric Medical Center - Chiba, Chiba, Japan
- National Kohnodai Medical Center - Ichikawa-shi, Chiba, Japan
- Fukuoka University Hospital - Fukuoka, Fukuoka, Japan
- Kuramitsu Hospital - Fukuoka, Fukuoka, Japan
- National Hospital Organization Kokura Medical Center Site - Kokuraminami-ku, Kitakyushu-shi, Fukuoka, Japan
- Shiranui Hospital - Omuta-shi, Fukuoka, Japan
- Social Medical Corporation Asaka Hospital - Kōriyama, Fukushima, Japan
- Hayakawa Clinic - Kure, Hiroshima, Japan
- NHO Kure Medical Center - Kure-shi, Hiroshima, Japan
- Nayoro City General Hospital - Nayoro-shi, Hokkaido, Japan
- Obihiro Kosei Hospital - Obihiro, Hokkaido, Japan
- Goryokai Medical Corporation Hospital - Sapporo, Hokkaido, Japan
- Iwate Medical University Hospital - Shiwa-gun, Iwate, Japan
- Hatano Kousei Hospital - Hadano-shi, Kanagawa, Japan
- Tanzawa Hospital - Hadano-shi, Kanagawa, Japan
- Fujimidai Hospital Site - Hiratsuka-shi, Kanagawa, Japan
- Yokohama Hino Hospital - Yokohama, Kanagawa, Japan
- Yuge Hospital - Kumamoto, Kumamoto, Japan
- Miyakonojo Shinsei Hospital - Miyakonojo-shi, Miyazaki, Japan
- Kansai Medical University Medical Center - Moriguchi-shi, Osaka, Japan
- Neyagawa Sanatorium - Neyagawa, Osaka, Japan
Showing 60 of 73 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →