RECRUITING

A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia

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Conditions

Schizophrenia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-02-28
Study Completion:2026-10-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06894212

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female participants between 18 to 65 years of age (inclusive) at the time of consent.
  2. * Participant has an identified reliable informant (eg, caregiver, relative, friend, case worker, residential treatment staff).
  3. * Participant is experiencing an acute exacerbation or relapse of symptoms, with onset ≤ 2 months prior to screening
  4. 1. The participant requires hospitalization for this acute exacerbation or relapse of symptoms.
  5. 2. If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening.
  6. * 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:
  7. 1. Participant must have a PANSS total score ≥ 80
  8. 2. Participant must have a CGI-S score ≥ 4.
  9. * 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.
  1. * 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.
  2. * Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia.
  3. * Participant has had psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days prior to screening.
  4. * Participant has previously received SEP-363856 or was previously enrolled in a SEP-363856 clinical study

Contacts and Locations

Study Contact

Otsuka Call Center
CONTACT
844-687-8522
Otsuka-ProfessionalServices@otsuka-us.com

Study Locations (Sites)

Pillar Clinical Research LLC - Bentonville Site # 145
Bentonville, Arkansas, 72712
United States
Pillar Clinical Research (Little Rock AR) Site #153
Little Rock, Arkansas, 72204
United States
Woodland International Research Group Site #141
Little Rock, Arkansas, 72211
United States
Woodland Research Northwest Site # 138
Rogers, Arkansas, 72758
United States
Clinical Innovations, Inc. dba CITrials (Bellflower) Site #131
Bellflower, California, 90706
United States
ProScience Research Group Site #134
Culver City, California, 90230
United States
CenExel CNS - Garden Grove (Collaborative Neuroscience Research) Site #123
Garden Grove, California, 92845
United States
Synergy San Diego Site #128
Lemon Grove, California, 91945
United States
Catalina Research Institute Site #142
Montclair, California, 91763
United States
Clinical Innovations Inc. DBA CITrials (Riverside) Site #151
Riverside, California, 92506
United States
Richmond Behavioral Associates LLC Site # 136
Riverside, California, 92506
United States
CNRI - San Diego LLC Site # 126
San Diego, California, 92123
United States
Schuster Medical Research Institute Site # 130
Sherman Oaks, California, 91403
United States
CenExel CNS - Los Alamitos (Collaborative Neuroscience Research) Site #149
Torrance, California, 90504
United States
Galiz Research Site #146
Hialeah, Florida, 33016
United States
Segal Trials - Larkin Behavioral Health - Inpatient & Early Phase Site #147
Hollywood, Florida, 33021
United States
Cenexel RCA (Research Centers of America) Site #124
Hollywood, Florida, 33024
United States
Premier Clinical Research Institute - Site #150
Miami, Florida, 33122
United States
D & H National Research Centers NC Site #143
Miami, Florida, 33155
United States
Innovative Clinical Research, Inc. Site # 125
Miami Lakes, Florida, 33016
United States
Health Synergy Clinical Research LLC Site #140
West Palm Beach, Florida, 33407
United States
Synexus Clinical Research US Inc - Atlanta Site #148
Atlanta, Georgia, 30328
United States
CenExel ACMR (Atlanta Center for Medical Research, LLC) Site #122
Atlanta, Georgia, 30331
United States
CenExel IRA (CenExcel iResearch, LLC) Site #132
Decatur, Georgia, 30030
United States
Accelerated Clinical Trials in Peachtree Corners GA Site # 127
Peachtree Corners, Georgia, 30071
United States
Uptown Research Institute Site # 121
Chicago, Illinois, 60640
United States
Pillar Clinical Research LLC (Chicago) Site #144
Chicago, Illinois, 60641
United States
Eastern Clinical Research Associates - Site # 156
New Orleans, Louisiana, 70127
United States
Cenexel CBH (CBH Health) Site # 129
Gaithersburg, Maryland, 20877
United States
Hassman Research Institute, LLC Site #120
Marlton, New Jersey, 20877
United States
Neuro-Behavioral Clinical Research Site # 135
Canton, Ohio, 44720
United States
Community Clinical Research Inc Site # 133
Austin, Texas, 78754
United States
InSite Clinical Research Site #152
DeSoto, Texas, 75115
United States
HD Research - Memorial Hermann Surgery Center Memorial Village Site #137
Houston, Texas, 77043
United States
Pillar Clinical Research LLC (Richardson, TX) Site #155
Richardson, Texas, 75080
United States

Collaborators and Investigators

Sponsor: Otsuka Pharmaceutical Development & Commercialization, 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 Registration Dates

Study Start Date2025-02-28
Study Completion Date2026-10-29

Study Record Updates

Study Start Date2025-02-28
Study Completion Date2026-10-29

Terms related to this study

Additional Relevant MeSH Terms

  • Schizophrenia