At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Aripiprazole, Haloperidol, and 7 other interventions for Schizophrenia and Psychotic Disorders. Completed, enrolled 337 participants across 38 sites in 3 countries.
Detailed 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.
Study Details
Timeline
Interventions
Aripiprazole will be administered in accordance with the label or Investigator's discretion
Haloperidol will be administered in accordance with the label or Investigator's discretion
Olanzapine will be administered in accordance with the label or Investigator's discretion
Paliperidone Extended Release (ER) tablets 1.5 to 12 milligram (mg) per day will be administered orally.
Perphenazine will be administered in accordance with the label or Investigator's discretion
Quetiapine will be administered in accordance with the label or Investigator's discretion
Risperidone tablets 1-6 mg per day will be administered orally.
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.
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.