A Study of Paliperidone Palmitate 6-Month Formulation



Status:Recruiting
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 70
Updated:3/17/2019
Start Date:November 20, 2017
End Date:August 31, 2020
Contact:Study Contact
Email:JNJ.CT@sylogent.com
Phone:844-434-4210

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A Double-blind, Randomized, Active-controlled, Parallel-group 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 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.).

The primary hypothesis of this study is that the efficacy of PP6M is non-inferior to PP3M for
preventing relapse in participants with schizophrenia who were previously stabilized on
corresponding doses of PP1M or PP3M. The study consists of mainly 3 phases: a screening phase
(up to 28 days), a maintenance phase (of 1 or 3 months), and a double-blind phase (of 12
months [neither the researchers nor the participants know what treatment the participant is
receiving]). Additional/conditional phases include a transition phase (before maintenance
phase). Study evaluations include efficacy, pharmacokinetics, pharmacodynamics, and safety.
The study duration will vary from approximately 13 months to 19 months.

Inclusion Criteria:

- 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

Exclusion Criteria

- 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
We found this trial at
29
sites
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Dayton, OH
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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Anaheim, CA
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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Chicago, Illinois 60640
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Chicago, IL
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Ciudad Autonoma De Buenos Aires,
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Cleveland, Ohio 44106
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Cleveland, OH
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Columbus, OH
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Costa Mesa, California 92626
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Dallas, Texas 78757
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Garden Grove, California 92845
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Glen Oaks, New York 11004
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550 Cherry Street Southeast
Grand Rapids, Michigan 49503
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Grand Rapids, MI
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Hialeah, Florida 33012
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Hialeah, FL
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Hickory, North Carolina 28601
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Hickory, NC
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1650 Moon Lake Boulevard
Hoffman Estates, Illinois 60169
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Hoffman Estates, IL
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Lemon Grove, California 91945
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10555 West Flagler Street
Miami, Florida 33174
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Miami, FL
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Miami, Florida 33135
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Miami, FL
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Oakland, California 94612
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Orange City, Florida 32763
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Orange City, FL
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Philadelphia, PA
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609 West Dyke Road
Rogers, Arkansas 72758
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Rogers, AR
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Saint Louis, Missouri 63141
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Saint Louis, MO
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Salt Lake City, Utah 84105
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San Antonio, Texas 78207
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1330 Lincoln Avenue
SAN RAFAEL, California 94901
(949) 683-1123
We are psychiatry clinic and a research facility based in San Rafael, California
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Tampa, Florida 33609
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Wichita, Kansas 67214
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