A Study of Paliperidone Palmitate 6-Month Formulation

Completed · Phase 3 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.).

Key facts

Study ID

NCT03345342

Run by

Janssen Research & Development, LLC

People needed

841

Starts

2017-11-20

Expected to finish

2020-05-08

Last updated by the study team

2025-04-29

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must meet the diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) for at least 6 months before screening
• Must be receiving treatment with paliperidone palmitate (as either the paliperidone palmitate 1-month (PP1M) or paliperidone palmitate 3-month (PP3M) formulation), or injectable risperidone, or any oral antipsychotic
• Must be able, in the opinion of the investigator, to discontinue any antipsychotic medication other than PP1M) or PP3M during the Screening Phase
• Must have a full Positive and Negative Syndrome Scale (PANSS) score of less than (<) 70 points at screening
• Must have a body mass index (BMI) between 17 and 40 kilogram (kg)/meter (m)\^2 (inclusive) and must have a body weight of at least 47 kg at screening
• Must be willing to receive gluteal injections of medication during the Double-blind Phase

You may not qualify if…

• Must not be receiving any form of involuntary treatment, such as involuntary psychiatric hospitalization, parole-mandated treatment, or court-mandated treatment
• Must not have attempted suicide within 12 months before screening and must not be at imminent risk of suicide or violent behavior, as clinically assessed by the investigator at the time of screening
• Must not have a DSM-5 diagnosis of moderate or severe substance use disorder (except for nicotine and caffeine) within 6 months of screening; however, acute or intermittent substance use prior to screening is not exclusionary, depending upon the clinical judgment of the investigator
• Must not have a history of neuroleptic malignant syndrome or tardive dyskinesia
• Must not have a history of intolerability or severe reactions to moderate or higher doses of antipsychotic medications and must not have any other factors that would, in the judgment of the investigator, indicate that treatment with moderate or higher doses of paliperidone palmitate would be intolerable or unsafe

Where it is running

• California Pharmaceutical Research Institute, Inc. — Anaheim, California, United States
• ATP Clinical Research — Costa Mesa, California, United States
• Collaborative NeuroScience Network — Garden Grove, California, United States
• Synergy East — Lemon Grove, California, United States
• Pacific Research Partners — Oakland, California, United States
• SF-Care, Inc — San Rafael, California, United States
• New Life Medical Research Center, Inc. — Hialeah, Florida, United States
• Clintex Research Group — Miami, Florida, United States
• Florida Research Center Inc. — Miami, Florida, United States
• Olympian Clinical Research — Tampa, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Uptown Research Institute — Chicago, Illinois, United States
• Alexian Behavioral Health Hospital — Hoffman Estates, Illinois, United States
• Ascension via Christi Research — Wichita, Kansas, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Cherry Street Services, Inc. — Grand Rapids, Michigan, United States
• St. Louis Clinical Trials — St Louis, Missouri, United States
• The Zucker Hillside Hospital — Glen Oaks, New York, United States
• Clinical Trials of America Inc — Hickory, North Carolina, United States
• Wexner Medical Center at the Ohio State University — Columbus, Ohio, United States
• Midwest Clinical Research Center — Dayton, Ohio, United States
• University of Pennsylvania Medical Center — Philadelphia, Pennsylvania, United States
• Future Search Trials of Dallas — Dallas, Texas, United States
• Psychiatric and Behavioral Solutions — Salt Lake City, Utah, United States
• Woodland Research Northwest — Rogers, Arkansas, United States

Full record on ClinicalTrials.gov

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