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NCT04865835 · ClinicalTrials.gov registry record · Phase 1

A Clinical Trial Study to Determine the Effect of an Investigational Drug (SEP-363856) Has on the Way That the Drug Metformin Travels Through the Body in People With Schizophrenia.

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

Completed
Registry status
Phase 1
Development phase
21
Enrollment target
2
Study locations

NCT04865835 is a Phase 1 study of Schizophrenia that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 21 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (90% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT04865835, a Phase 1 study of Schizophrenia, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 1
Development phase
21 participants
Enrollment target
2
Study locations

Study Summary

A clinical trial study to determine the effect of an investigational drug (SEP-363856) has on the way that the drug Metformin travels through the body in people with schizophrenia. This clinical trial will have approximately 24 subjects both male and female 18 year of age and older. This study will be conducted in approximately 2 study sites in the United States.

Conditions Studied

Schizophrenia

Interventions

  • DRUG placebo
  • DRUG metformin
  • DRUG SEP-363856

Study Locations (2)

Florida

  • At Fort Lauderdale Behavioral Health Center - Oakland Park

New Jersey

  • Hassman Research Institute - Marlton

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2021-05-12
Est. Completion 2022-05-03
Phase Phase 1

Sponsor

Otsuka Pharmaceutical Development & Commercialization

221 total trials

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What the Registry Record Tells You About NCT04865835

The ClinicalTrials.gov registry entry for NCT04865835 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 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 (90% 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 3 interventions - of which placebo is the first listed.

NCT04865835 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Florida, New Jersey.

Frequently Asked Questions

What is clinical trial NCT04865835 about?

NCT04865835 is a clinical study titled "A Clinical Trial Study to Determine the Effect of an Investigational Drug (SEP-363856) Has on the Way That the Drug Metformin Travels Through the Body in People With Schizophrenia.". A clinical trial study to determine the effect of an investigational drug (SEP-363856) has on the way that the drug Metformin travels through the body in people with schizophrenia. This clinical trial will have approximately 24 subjects both male and female 18 year of age and older. This study will ...

What is the current status of trial NCT04865835?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2021-05-12. Estimated completion is 2022-05-03.

What conditions does trial NCT04865835 study?

This clinical trial studies the following conditions: Schizophrenia.

What interventions are being tested in trial NCT04865835?

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

Who is sponsoring clinical trial NCT04865835?

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

Where is trial NCT04865835 being conducted?

This trial has 2 study locations across Florida, New Jersey. 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.