Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia
Public ClinicalTrials.gov record NCT01515423. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects With Schizophrenia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01515423
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,429 participants
Conditions and interventions
Conditions
Interventions
- PP3M 175 mg eq. Drug
- PP3M 263 mg eq. Drug
- PP3M 350 mg eq. Drug
- PP3M 525 mg eq. Drug
- Placebo (20% Intralipid) Drug
- PP1M 50 mg eq. Drug
- PP1M 75 mg eq. Drug
- PP1M 100 mg eq. Drug
- PP1M 150 mg eq. Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2012
- Primary completion
- Jan 31, 2015
- Completion
- Feb 28, 2015
- Last update posted
- May 1, 2016
2012 – 2015
United States locations
- U.S. sites
- 24
- U.S. states
- 17
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Little Rock | Arkansas | — | — |
| Not listed | Glendale | California | — | — |
| Not listed | Long Beach | California | — | — |
| Not listed | Oakland | California | — | — |
| Not listed | Oceanside | California | — | — |
| Not listed | Orange | California | — | — |
| Not listed | San Diego | California | — | — |
| Not listed | New Britain | Connecticut | — | — |
| Not listed | Bradenton | Florida | — | — |
| Not listed | Kissimmee | Florida | — | — |
| Not listed | Tampa | Florida | — | — |
| Not listed | Wichita | Kansas | — | — |
| Not listed | East Lansing | Michigan | — | — |
| Not listed | St Louis | Missouri | — | — |
| Not listed | Las Vegas | Nevada | — | — |
| Not listed | Jamaica | New York | — | — |
| Not listed | Durham | North Carolina | — | — |
| Not listed | Canton | Ohio | — | — |
| Not listed | Oklahoma City | Oklahoma | — | — |
| Not listed | Philadelphia | Pennsylvania | — | — |
| Not listed | Charleston | South Carolina | — | — |
| Not listed | Memphis | Tennessee | — | — |
| Not listed | Austin | Texas | — | — |
| Not listed | Bothell | Washington | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 150 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01515423, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 1, 2016 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01515423 live on ClinicalTrials.gov.