Last updated on November 2018

A Study to Compare Disease Progression and Modification Following Treatment With Paliperidone Palmitate Long-Acting Injection or Oral Antipsychotics in Participant's With Recent-onset Schizophrenia or Schizophreniform


Brief description of study

The purpose of the study is to compare effectiveness of paliperidone palmitate (PP: paliperidone palmitate once-monthly and 3-month injections) versus oral antipsychotic (OAP [that is oral paliperidone extended release {ER}, oral risperidone, or another OAP]) in delaying time to treatment failure. The study will also evaluate changes in cognition, functioning, brain intracortical myelin (ICM) volume following treatment with PP compared with OAP in participants with recent-onset schizophrenia or schizophreniform disorder.

Detailed Study Description

A Prospective, matched-control, Randomized (assignment of study drug by chance), open-label, flexible-dose, study in participants with recent-onset schizophrenia or schizophreniform disorder to compare disease progression and disease modification following treatment with PP long-acting injection (once-monthly followed by 3-month injections) or OAP (Any of the following 7 OAPs are permitted: aripiprazole, haloperidol, olanzapine, paliperidone ER, perphenazine, quetiapine, and risperidone). The study consists of 3 parts. Part-1 (Oral Run-In Phase), Part-2 (Disease Progression) and Part-3 (Extended Disease Progression and Disease Modification) with unique endpoints. Screening period will be up to 4 Weeks. Duration of Parts will be as: 2 months for Part-1, 9 months for Part-2 and Part-3. All participants will initially receive oral paliperidone ER or oral risperidone in Part-1. After paliperidone/risperidone treatment in Part-1, participants will be randomized into 1:2 ratio to receive PP or OAP in Part-2. Participants who complete Part-2 will enter into Part-3 wherein OAP group participants of Part-2 will be re-randomized into 1:1 ratio to OAP-OAP group and OAP-PP group, and PP group will continue without further randomization. Treatment failures will be evaluated in Part-2 and Part-3 of the study. Also changes in cognition, functioning, brain intracortical myelin (ICM) volume will be evaluated in the study. Participants' safety will be monitored throughout.

Clinical Study Identifier: NCT02431702

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University of Arkansas for Medical Sciences/Psychiatric Research Institute
Little Rock, AR United States

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Collaborative NeuroScience Network
Garden Grove, CA United States

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Synergy East
Lemon Grove, CA United States

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UCLA Department of Psychiatry
Los Angeles, CA United States

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University of California San Diego/Psychiatry
San Diego, CA United States

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SF-Care, Inc
San Rafael, CA United States

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Stanford School of Medicine
Stanford, CA United States

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Kaweah Delta Health Care District, GME
Visalia, CA United States

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Henderson Behavioral Health
Lauderdale Lakes, FL United States

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LifeStream Behavioral Center
Leesburg, FL United States

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Jackson Behavioral Health Hospital
Miami, FL United States

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Olympian Clinical Research
Tampa, FL United States

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Jerome Golden Center for Behavioral Health, Inc.
West Palm Beach, FL United States

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Uptown Research Institute
Chicago, IL United States

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Chestnut Health Systems
Granite City, IL United States

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Alexian Behavioral Health Hospital
Hoffman Estates, IL United States

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Indiana University/Psychiatry
Indianapolis, IN United States

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University of Louisville, Department of Psychiatry
Louisville, KY United States

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MGH
Boston, MA United States

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UMass Medical School
Worcester, MA United States

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ETCH - Early Treatment and Cognitive Health
East Lansing, MI United States

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Heart of the City Health Center/ Cherry Health
Grand Rapids, MI United States

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HealthWest
Muskegon, MI United States

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Saint Louis University Department of Neurology and Psychiatry
Saint Louis, MO United States

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Creighton University
Omaha, NE United States

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University of New Mexico
Albuquerque, NM United States

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Neurobehavioral Research, Inc
Cedarhurst, NY United States

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Finger Lakes Clinical Research
Rochester, NY United States

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Behavioral Medical Research
Staten Island, NY United States

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New Hope Clinical Research
Charlotte, NC United States

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University of Cincinnati Hospital
Cincinnati, OH United States

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The Ohio State University
Columbus, OH United States

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Peace Health
Eugene, OR United States

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University of Pennsylvania Medical Center
Philadelphia, PA United States

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Community Clinical Research Inc
Austin, TX United States

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Zain Research LLC
Richland, WA United States

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Instituto Bairral de Psiquiatria
Itapira, Brazil

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Centro de Psiquiatria e Pesquisas Sandra Ruschel
Rio De Janeiro, Brazil

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Instituto Nacional de Neurolog a y Neurocirug a
Mexico, Mexico

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Baylor College of Medicine
Houston, TX United States

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Geisel School of Medicine at Dartmouth, Dept of Psychiatry
Lebanon, NH United States

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Pacific Institute of Medical Sciences
Bothell, WA United States

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Instituto de Psiquiatria de Santa Catarina - IPqSC
São José, Brazil