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NCT03978832 · ClinicalTrials.gov registry record · Phase 4

Safety, Tolerability, Pharmacokinetics and Efficacy of 180 mg Subcutaneous Risperidone From 6 mg Oral Risperidone

A Phase 4 study of Schizophrenia, sponsored by Indivior.

Completed
Registry status
Phase 4
Development phase
69
Enrollment target
1
Study location

NCT03978832 is a Phase 4 study of Schizophrenia that has completed, run by Indivior. The registered enrollment target is 69 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03978832, a Phase 4 study of Schizophrenia, has completed, sponsored by Indivior.

COMPLETED
Registry status
Phase 4
Development phase
69 participants
Enrollment target
1
Study location

Study Summary

This study evaluates PERSERIS at a higher dose than what has been administered in previous clinical trials. Subjects with stable schizophrenia on a dose of 5-6 mg oral risperidone will be switched to PERSERIS at the higher dose, which is believed to be similar to the oral dose

Conditions Studied

Interventions

  • DRUG Risperidone
  • DRUG PERSERIS

Study Locations (1)

California

  • Collaborative Neuroscience Network - Garden Grove

Trial Details

FieldValue
Enrollment Target 69 participants
Start Date 2019-06-28
Est. Completion 2020-05-12
Phase Phase 4

Sponsor

Indivior

37 total trials

What the Registry Record Tells You About NCT03978832

The ClinicalTrials.gov registry entry for NCT03978832 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 69 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 (68% lower). The listed sponsor is Indivior, which has 37 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 Risperidone is the first listed.

NCT03978832 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT03978832 about?

NCT03978832 is a clinical study titled "Safety, Tolerability, Pharmacokinetics and Efficacy of 180 mg Subcutaneous Risperidone From 6 mg Oral Risperidone". This study evaluates PERSERIS at a higher dose than what has been administered in previous clinical trials. Subjects with stable schizophrenia on a dose of 5-6 mg oral risperidone will be switched to PERSERIS at the higher dose, which is believed to be similar to the oral dose

What is the current status of trial NCT03978832?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 69 participants. The study started on 2019-06-28. Estimated completion is 2020-05-12.

What conditions does trial NCT03978832 study?

This clinical trial studies the following conditions: Schizophrenia.

What interventions are being tested in trial NCT03978832?

The interventions under investigation include: Risperidone (DRUG), PERSERIS (DRUG).

Who is sponsoring clinical trial NCT03978832?

This trial is sponsored by Indivior, which has 37 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03978832 being conducted?

This trial has 1 study location across California. 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.