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

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.

Conditions

• Schizophrenia
• Psychotic Disorders

Interventions

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.

Sponsors & Collaborators

• Janssen Scientific Affairs, LLC

  lead INDUSTRY

Principal Investigators

• Janssen Scientific Affairs, LLC Clinical Trial · Janssen Scientific Affairs, LLC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-07-08

Primary Completion

2019-11-12

Completion

2019-11-12

Countries

• United States
• Brazil
• Mexico

Study Locations