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A Clinical Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic People With Schizophrenia, Followed by an Open-label Extension Phase

NCT04825860 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2024-03-15

No results posted yet for this study

Summary

A clinical study to investigate the effect of 2 doses of an investigational drug in acutely psychotic adult patients with schizophrenia. The study will consist of a double-blind phase followed by an open-label extension phase.

Conditions

Interventions

DRUG

SEP-363856 50 mg

Subjects will take one tablet of study drug per day at approximately the same time each evening at bedtime. Study drug may be taken orally with or without food.

DRUG

SEP-363856 75 mg

Subjects will take one tablet of study drug per day at approximately the same time each evening at bedtime. Study drug may be taken orally with or without food.

DRUG

Placebo

Subjects will take one tablet of study drug per day at approximately the same time each evening at bedtime. Study drug may be taken orally with or without food.

Sponsors & Collaborators

  • Sumitomo Pharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-29
Primary Completion
2023-10-12
Completion
2023-10-19

Countries

  • China
  • Japan
  • Philippines
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04825860 on ClinicalTrials.gov