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Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia
NCT01515423 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to demonstrate that a paliperidone palmitate 3 month formulation (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the treatment of patients with schizophrenia who have been stabilized on PP1M.
Conditions Studied
Interventions
- DRUG PP3M 350 mg eq.
- DRUG PP3M 525 mg eq.
- DRUG PP3M 175 mg eq.
- DRUG PP3M 263 mg eq.
- DRUG Placebo (20% Intralipid)
Study Locations (20)
California
- — Glendale
- — Long Beach
- — Oakland
- — Oceanside
- — Orange
- — San Diego
Florida
- — Bradenton
- — Kissimmee
- — Tampa
Arkansas
- — Little Rock
Connecticut
- — New Britain
Kansas
- — Wichita
Michigan
- — East Lansing
Missouri
- — St Louis
Nevada
- — Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,429 participants |
| Start Date | 2012-05 |
| Est. Completion | 2015-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01515423
The ClinicalTrials.gov registry entry for NCT01515423 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 1,429 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 PP3M 350 mg eq. 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: NCT01515423 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, Arkansas. 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 NCT01515423 about?
NCT01515423 is a clinical study titled "Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia". The purpose of this study is to demonstrate that a paliperidone palmitate 3 month formulation (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the treatment of patients with schizophrenia who have been stabilized on PP1M.
What is the current status of trial NCT01515423?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,429 participants. The study started on 2012-05. Estimated completion is 2015-03.
What conditions does trial NCT01515423 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 NCT01515423?
The interventions under investigation include: PP3M 350 mg eq. (DRUG), PP3M 525 mg eq. (DRUG), PP3M 175 mg eq. (DRUG), PP3M 263 mg eq. (DRUG), Placebo (20% Intralipid) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01515423?
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 NCT01515423 being conducted?
This trial has 20 study locations across Arkansas, California, Connecticut, Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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