A Study of Paliperidone Palmitate 6-Month Formulation
Public ClinicalTrials.gov record NCT03345342. 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 Double-blind, Randomized, Active-controlled, Parallel-group Study of Paliperidone Palmitate 6-Month Formulation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.).
Study identification
- NCT ID
- NCT03345342
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 841 participants
Conditions and interventions
Conditions
Interventions
- PP6M Drug
- PP3M 350 mg eq. Drug
- PP3M 525 mg eq. Drug
- PP1M Drug
- Placebo Other
Drug · Other
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
- Nov 19, 2017
- Primary completion
- May 7, 2020
- Completion
- May 7, 2020
- Last update posted
- Apr 28, 2025
2017 – 2020
United States locations
- U.S. sites
- 25
- U.S. states
- 15
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Woodland Research Northwest | Rogers | Arkansas | 72758 | — |
| California Pharmaceutical Research Institute, Inc. | Anaheim | California | 92804 | — |
| ATP Clinical Research | Costa Mesa | California | 92626 | — |
| Collaborative NeuroScience Network | Garden Grove | California | 92845 | — |
| Synergy East | Lemon Grove | California | 91945 | — |
| Pacific Research Partners | Oakland | California | 94607 | — |
| SF-Care, Inc | San Rafael | California | 94901 | — |
| New Life Medical Research Center, Inc. | Hialeah | Florida | 33012 | — |
| Clintex Research Group | Miami | Florida | 33135 | — |
| Florida Research Center Inc. | Miami | Florida | 33174 | — |
| Olympian Clinical Research | Tampa | Florida | 33614 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | — |
| Uptown Research Institute | Chicago | Illinois | 60640 | — |
| Alexian Behavioral Health Hospital | Hoffman Estates | Illinois | 60169 | — |
| Ascension via Christi Research | Wichita | Kansas | 67214 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Cherry Street Services, Inc. | Grand Rapids | Michigan | 49503 | — |
| St. Louis Clinical Trials | St Louis | Missouri | 63141 | — |
| The Zucker Hillside Hospital | Glen Oaks | New York | 11004 | — |
| Clinical Trials of America Inc | Hickory | North Carolina | 28601 | — |
| Wexner Medical Center at the Ohio State University | Columbus | Ohio | 43210 | — |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | — |
| University of Pennsylvania Medical Center | Philadelphia | Pennsylvania | 19104 | — |
| Future Search Trials of Dallas | Dallas | Texas | 75231 | — |
| Psychiatric and Behavioral Solutions | Salt Lake City | Utah | 84105-2425 | — |
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 113 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03345342, 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 Apr 28, 2025 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03345342 live on ClinicalTrials.gov.