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A Study of Paliperidone Palmitate 6-Month Formulation

NCT03345342 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 841

Last updated 2025-04-29

Study results available
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Summary

The purpose of this study is to demonstrate that injection cycles consisting of a single administration of paliperidone palmitate 6-month (PP6M) are not less effective than 2 sequentially administered injections of paliperidone palmitate 3-month PP3M) (350 or 525 mg eq.) for the prevention of relapse in participants with schizophrenia previously stabilized on corresponding doses of paliperidone palmitate 1-month (PP1M) (100 or 150 mg eq.) or PP3M (350 or 525 mg eq.).

Conditions

Interventions

DRUG

PP6M

Participants will receive intramuscular injection of PP6M.

DRUG

PP3M 350 mg eq.

Participants will receive intramuscular injection of PP3M 350 mg eq.

DRUG

PP3M 525 mg eq.

Participants will receive intramuscular injection of PP3M 525 mg eq.

DRUG

PP1M

Participants will receive intramuscular injection of PP1M 50 to 150 mg eq.

OTHER

Placebo

Participants will receive matching placebo.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-11-20
Primary Completion
2020-05-08
Completion
2020-05-08
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Bulgaria
  • Czechia
  • France
  • Hong Kong
  • Hungary
  • India
  • Italy
  • Malaysia
  • Mexico
  • Poland
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine

Study Locations

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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 NCT03345342 on ClinicalTrials.gov