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NCT05848700 · ClinicalTrials.gov registry record · Phase 1

A Clinical Study to Learn if SEP-363856 Has Physical Dependence in Adults With Schizophrenia

A Phase 1 study of Schizophrenia, sponsored by Otsuka Pharmaceutical Development & Commercialization.

Completed
Registry status
Phase 1
Development phase
60
Enrollment target
7
Study locations

NCT05848700 is a Phase 1 study of Schizophrenia that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 60 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (73% lower). The trial reports 7 study locations across 5 states.

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The verdict

NCT05848700, a Phase 1 study of Schizophrenia, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 1
Development phase
60 participants
Enrollment target
7
Study locations

Study Summary

A Clinical Study to learn if SEP-363856 has physical dependence in adults with schizophrenia. This study will be held in approximately 6 study sites in the United States. It will be accepting male and female participants age 18 years to 65 years. Participation will be up to approximately10 weeks.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG SEP-363856

Study Locations (7)

Arkansas

  • Woodland International Research Group, LLC - Little Rock
  • Woodland Research Northwest - Rogers

Florida

  • Behavioral Clinical Research, Inc - Miami Lakes
  • Research Centers of America at Fort Lauderdale Behavioral Health Center - Oakland Park

Georgia

  • Atlanta Center for Medical Research - Atlanta

Ohio

  • Neuro-Behavioral Clinical Research, Inc - North Canton

Texas

  • Pillar Clinical Research, LLC - Richardson

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2023-06-21
Est. Completion 2024-03-15
Phase Phase 1

What the Registry Record Tells You About NCT05848700

The ClinicalTrials.gov registry entry for NCT05848700 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (73% lower). The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05848700 reports 7 study locations spanning 5 distinct geographic areas - top geographies include Arkansas, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT05848700 about?

NCT05848700 is a clinical study titled "A Clinical Study to Learn if SEP-363856 Has Physical Dependence in Adults With Schizophrenia". A Clinical Study to learn if SEP-363856 has physical dependence in adults with schizophrenia. This study will be held in approximately 6 study sites in the United States. It will be accepting male and female participants age 18 years to 65 years. Participation will be up to approximately10 weeks.

What is the current status of trial NCT05848700?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2023-06-21. Estimated completion is 2024-03-15.

What conditions does trial NCT05848700 study?

This clinical trial studies the following conditions: Schizophrenia.

What interventions are being tested in trial NCT05848700?

The interventions under investigation include: Placebo (DRUG), SEP-363856 (DRUG).

Who is sponsoring clinical trial NCT05848700?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05848700 being conducted?

This trial has 7 study locations across Arkansas, Florida, Georgia, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.