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Recruiting NCT06894212

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

Phase III Interventional Schizophrenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SEP-363856, Placebo.
Who it may be relevant to
Registry conditions: Schizophrenia. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia

Detailed description

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

Interventions

  • Drug SEP-363856
    tablet
  • Other Placebo
    tablet

Primary outcome measures

  • The change from baseline in Positive And Negative Syndrome Scale (PANSS) total score at Week 6 [Time frame: Baseline to Week 6]
Secondary outcome measures (1)
  • Clinical Global Impression-Severity (CGI-S) [Time frame: Baseline to Week 6]

Eligibility criteria

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.

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Japan · 38 centers
  • Hotei Hospital — Konan-shi
  • Seishinkai Okehazama Hospital — Toyoake-shi
  • Seijinkai Seinan Hospital — Hachinohe-shi
  • National Hospital Organization Shimofusa Psychiatric Medical Center — Chiba
  • National Kohnodai Medical Center — Ichikawa-shi
  • Fukuoka University Hospital — Fukuoka
  • Kuramitsu Hospital — Fukuoka
  • National Hospital Organization Kokura Medical Center Site — Kokuraminami-ku, Kitakyushu-shi
  • … and 30 more centers
United States · 35 centers
  • Pillar Clinical Research LLC - Bentonville Site — Bentonville
  • Pillar Clinical Research (Little Rock AR) Site — Little Rock
  • Woodland International Research Group Site — Little Rock
  • Woodland Research Northwest Site — Rogers
  • Clinical Innovations, Inc. dba CITrials (Bellflower) — Bellflower
  • ProScience Research Group Site — Culver City
  • CenExel CNS - Garden Grove (Collaborative Neuroscience Research) Site — Garden Grove
  • Synergy San Diego Site — Lemon Grove
  • … and 27 more centers

Identifiers

NCT: NCT06894212 · 382-201-00035

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗