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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 Failure

Part-3: Change From Baseline in MATRICS Consensus Cognitive Battery (MCCB) Score

Secondary outcome:

Part-2: Change From Baseline in MCCB Score

Change 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

Page last updated: August 23, 2015

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