MedTrace Logo

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

NCT03978832 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2021-07-07

Study results available
· View outcomes & findings →

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

Interventions

DRUG

PERSERIS

PERSERIS is an extended-release SC injectable suspension administered once-monthly

DRUG

Risperidone

Oral risperidone

Sponsors & Collaborators

  • Indivior Inc.

    lead INDUSTRY

Principal Investigators

  • David Walling · Collaborative Neuroscience Network

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-06-28
Primary Completion
2020-05-12
Completion
2020-05-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT03978832 on ClinicalTrials.gov