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

PHASE3CompletedINTERVENTIONAL
Enrollment

337

Participants

Timeline

Start Date

July 8, 2015

Primary Completion Date

November 12, 2019

Study Completion Date

November 12, 2019

Conditions
SchizophreniaPsychotic 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.

Trial Locations (38)

Unknown

Little Rock

Garden Grove

Lemon Grove

Los Angeles

San Diego

San Rafael

Stanford

Lauderdale Lakes

Leesburg

Miami

Tampa

West Palm Beach

Chicago

Granite City

Hoffman Estates

Indianapolis

Louisville

Boston

Worcester

East Lansing

Grand Rapids

Muskegon

Omaha

Albuquerque

Cedarhurst

Rochester

Staten Island

Charlotte

Cincinnati

Columbus

Eugene

Philadelphia

Houston

Bothell

Itapira

Rio de Janeiro

São José

México

All Listed Sponsors
lead

Janssen Scientific Affairs, LLC

INDUSTRY

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 | Biotech Hunter | Biotech Hunter