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COMPLETED Phase 3

A Study of Paliperidone Palmitate 6-Month Formulation

NCT03345342 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • OTHER Placebo
  • DRUG PP6M
  • DRUG PP3M 350 mg eq.
  • DRUG PP3M 525 mg eq.
  • DRUG PP1M

Study Locations (20)

California

  • California Pharmaceutical Research Institute, Inc. — Anaheim
  • ATP Clinical Research — Costa Mesa
  • Collaborative NeuroScience Network — Garden Grove
  • Synergy East — Lemon Grove
  • Pacific Research Partners — Oakland
  • SF-Care, Inc — San Rafael

Florida

  • New Life Medical Research Center, Inc. — Hialeah
  • Clintex Research Group — Miami
  • Florida Research Center Inc. — Miami
  • Olympian Clinical Research — Tampa

Illinois

  • Uptown Research Institute — Chicago
  • Alexian Behavioral Health Hospital — Hoffman Estates

Arkansas

  • Woodland Research Northwest — Rogers

Georgia

  • Atlanta Center for Medical Research — Atlanta

Kansas

  • Ascension via Christi Research — Wichita

Massachusetts

  • Massachusetts General Hospital — Boston

Michigan

  • Cherry Street Services, Inc. — Grand Rapids

Trial Details

FieldValue
Enrollment Target 841 participants
Start Date 2017-11-20
Est. Completion 2020-05-08
Phase Phase 3

Sponsor

Janssen Research & Development

442 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03345342

The ClinicalTrials.gov registry entry for NCT03345342 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 841 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 5 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03345342 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03345342 about?

NCT03345342 is a clinical study titled "A Study of Paliperidone Palmitate 6-Month Formulation". 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 relaps...

What is the current status of trial NCT03345342?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 841 participants. The study started on 2017-11-20. Estimated completion is 2020-05-08.

What conditions does trial NCT03345342 study?

This clinical trial studies the following conditions: Schizophrenia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03345342?

The interventions under investigation include: Placebo (OTHER), PP6M (DRUG), PP3M 350 mg eq. (DRUG), PP3M 525 mg eq. (DRUG), PP1M (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03345342?

This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03345342 being conducted?

This trial has 20 study locations across Arkansas, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial