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Completed Phase 1 Interventional

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.

ClinicalTrials.gov ID: NCT04865835

Public ClinicalTrials.gov record NCT04865835. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 12:17 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Single-blind, Two-period Crossover to Investigate the Effect of SEP-363856 on the Pharmacokinetics of Metformin in Subjects With Schizophrenia.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04865835
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
21 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 11, 2021
Primary completion
May 2, 2022
Completion
May 2, 2022
Last update posted
Jun 25, 2024

2021 – 2022

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
At Fort Lauderdale Behavioral Health Center Oakland Park Florida 33334
Hassman Research Institute Marlton New Jersey 08053

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Recently updated Schizophrenia trials

Other public records listing Schizophrenia. Sorted by last update posted; newest first. Not a recommendation.

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About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04865835, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 25, 2024 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04865835 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →