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
Information source: Janssen Scientific Affairs, LLC
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Psychotic Disorders
Intervention: Aripiprazole (Drug); Haloperidol (Drug); Olanzapine (Drug); Paliperidone ER (Drug); Perphenazine (Drug); Quetiapine (Drug); Risperidone (Drug); Paliperidone Palmitate Injection (PP1M) (Drug); Paliperidone Palmitate Injection (PP3M) (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Janssen Scientific Affairs, LLC Official(s) and/or principal investigator(s): Janssen Scientific Affairs, LLC Clinical Trial, Study Director, Affiliation: Janssen Scientific Affairs, LLC
Overall contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: JNJ.CT@sylogent.com
Summary
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)
on 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.
Clinical Details
Official title: A Prospective, Matched-Control, Randomized, Open-Label, Flexible-Dose, Study in Subjects With Recent-Onset Schizophrenia or Schizophreniform Disorder to Compare Disease Progression and Disease Modification Following Treatment With Paliperidone Palmitate Long-Acting Injection or Oral Antipsychotics
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Part-2: Time to First Treatment FailurePart-3: Change From Baseline in MATRICS Consensus Cognitive Battery (MCCB) Score
Secondary outcome: Part-2: Change From Baseline in MCCB ScoreChange From Baseline in Personal and Social Performance (PSP) Total Score Change From Baseline in Brain Intracortical Myelin (ICM) Volume Change From Baseline in Clinical Global Impression Severity (CGI-S) Score Change From Baseline in Clinician-Rated Dimensions of Psychosis Symptom Severity Scale (CRDPSS) Change From Baseline Medication Satisfaction Questionnaire (MSQ) Score Number of Participants with Adverse Events (AEs) and Serious AEs
Detailed 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 Extended Release (ER) in Part-1. After
paliperidone 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Participant must have a current diagnosis of schizophrenia (295. 90) or
schizophreniform disorder (295. 40) as defined by Diagnostic and Statistical Manual of
Mental Disorders, 5th edition (DSM-5) and confirmed by the Structured Clinical
Interview for DSM-5 Disorders (SCID) with a first psychotic episode within the last
24 months
- Participant requires treatment with an antipsychotic medication
- Participant must sign an informed consent form (ICF) indicating that he or she
understands the purpose of and procedures required for the study and are willing to
participate in the study
- Participant must have available a designated individual (example, family member,
significant other, friend) who has knowledge of the participant and is generally
aware of the participants daily activities, and who agrees to let the study site
personnel know of changes in the participants circumstances when the participant is
not able to provide this information. The designated individual must sign an informed
consent form
- Participant is anticipated to have a stable place of residence for the duration of
the trial
Exclusion Criteria:
- Participant has a current DSM-5 diagnosis of dissociative disorder, bipolar disorder,
major depressive disorder, schizoaffective disorder, autistic disorder, or
intellectual disabilities
- Participant meets the DSM-5 definition of moderate or severe substance use disorder
(except for nicotine) within 2 months prior to Screening
- Participant has a history of neuroleptic malignant syndrome
- Participant has received long-acting injectable (LAI) medication within 2 injection
cycles prior to the Screening visit
- Participant has mental retardation, defined as pre-morbid intelligence quotient (IQ)
as measured by Wechsler Test of Adult Reading at Screening less than (<) 70
Locations and Contacts
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: JNJ.CT@sylogent.com
Little Rock, Arkansas, United States; Not yet recruiting
Escondido, California, United States; Recruiting
Garden Grove, California, United States; Not yet recruiting
La Jolla, California, United States; Not yet recruiting
Los Angeles, California, United States; Not yet recruiting
San Rafael, California, United States; Recruiting
Visalia, California, United States; Not yet recruiting
Miami, Florida, United States; Not yet recruiting
Tampa, Florida, United States; Recruiting
Chicago, Illinois, United States; Recruiting
Hoffman Estates, Illinois, United States; Not yet recruiting
Indianapolis, Indiana, United States; Withdrawn
Louisville, Kentucky, United States; Not yet recruiting
Boston, Massachusetts, United States; Not yet recruiting
Worcester, Massachusetts, United States; Not yet recruiting
St. Louis, Missouri, United States; Not yet recruiting
Albuquerque, New Mexico, United States; Not yet recruiting
Cedarhurst, New York, United States; Not yet recruiting
Staten Island, New York, United States; Not yet recruiting
Charlotte, North Carolina, United States; Not yet recruiting
Cincinnati, Ohio, United States; Not yet recruiting
Austin, Texas, United States; Not yet recruiting
Additional Information
To learn how to participate in this trial please click here.
Starting date: July 2015
Last updated: August 21, 2015
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