NCT02431702

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 337 (actual)
• Sponsor: Janssen Scientific Affairs, LLC · Industry
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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 \[that is oral paliperidone extended release {ER}, oral risperidone, or another OAP\]) 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 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. Healthy controls (comparable in age, sex, race, and highest parental education to the treated participants) were recruited at each of the 3 MRI centers as controls for the MRI machine calibration for the duration of the study. These healthy controls were to undergo MRI assessments, but were not otherwise involved with the study and did not receive study medication. No safety or efficacy data were collected for these healthy controls.

Conditions

• Schizophrenia
• Psychotic Disorders

Interventions

Type	Name	Description
DRUG	Aripiprazole	Aripiprazole will be administered in accordance with the label or Investigator's discretion
DRUG	Haloperidol	Haloperidol will be administered in accordance with the label or Investigator's discretion
DRUG	Olanzapine	Olanzapine will be administered in accordance with the label or Investigator's discretion
DRUG	Oral Paliperidone ER	Paliperidone Extended Release (ER) tablets 1.5 to 12 milligram (mg) per day will be administered orally.
DRUG	Perphenazine	Perphenazine will be administered in accordance with the label or Investigator's discretion
DRUG	Quetiapine	Quetiapine will be administered in accordance with the label or Investigator's discretion
DRUG	Oral Risperidone	Risperidone tablets 1-6 mg per day will be administered orally.
DRUG	Paliperidone Palmitate Injection (PP1M)	Participants will receive 5 doses of PP1M. First dose at a starting dose of 234 mg on Day 1 and a second dose of 156 mg on Day 8 and then 78 to 234 mg (in 3 flexible doses), every month up to Day 92.
DRUG	Paliperidone Palmitate Injection (PP3M)	Paliperidone Palmitate injection (PP3M) will be administered once every 12 weeks intramuscularly. The initial dose will be calculated as 3.5 fold multiple of the final PP1M dose administered on Day 92 (or Day 176). Dose will be increased based on Investigator's discretion.

Timeline

• Start date: 2015-07-08
• Primary completion: 2019-11-12
• Completion: 2019-11-12
• First posted: 2015-05-01
• Last updated: 2025-04-29
• Results posted: 2021-01-19

Locations

38 sites across 3 countries: United States, Brazil, Mexico