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

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. to Otsuka Pharmaceutical Development & Commercialization, Inc. Enrollment closed, study ongoing · Enrollment target: estimated 522 to confirmed 538 · Eligibility criteria expanded, about 13 words · 2 more Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Enrollment target: estimated 522 to confirmed 538
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised at 73 of 73 sites
  2. Site details revised at 14 of 73 sitesv9
  3. Site details revised at 1 of 73 sitesv8
  4. Site details revised at 2 of 73 sitesv7
  5. Trial sites expanded: 60 → 73 locationsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 35 to 60v5
  2. Primary completion date: Apr 6, 2028 to Oct 20, 2026 Study sites: 36 to 35 · Completion date: Aug 31, 2028 to Oct 29, 2026 · Start date: Feb 25, 2025 to Feb 28, 2025 · 2 morev4 Show 5 more changesShow less
    • Study sites: 36 to 35
    • Completion date: Aug 31, 2028 to Oct 29, 2026
    • Start date: Feb 25, 2025 to Feb 28, 2025
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 23 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 34 to 36 Secondary endpoints: details revised at 1 of 1 entryv3 Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 1 entry
  4. Study sites: 11 to 34 Eligibility criteria shortened, about 118 words · Secondary endpoints: details revised at 1 of 1 entryv2 Show 2 more changesShow less
    • Eligibility criteria shortened, about 118 words
    • Secondary endpoints: details revised at 1 of 1 entry

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia
Trial Details
NCT Number NCT06894212
Lead Sponsor Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions Schizophrenia
Enrollment 538 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov