Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia

Summary

The purpose of this study is to demonstrate that a paliperidone palmitate 3 month formulation (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the treatment of patients with schizophrenia who have been stabilized on PP1M.

Conditions

• Schizophrenia

Interventions

DRUG

PP3M 175 mg eq.

Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use. One injection every third month for 48 weeks.

DRUG

PP3M 263 mg eq.

Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use. One injection every third month for 48 weeks.

DRUG

PP3M 350 mg eq.

Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use. One injection every third month for 48 weeks.

DRUG

PP3M 525 mg eq.

Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use. One injection every third month for 48 weeks.

DRUG

Placebo (20% Intralipid)

Form= injection, route= intramuscular use. One injection monthly when not receiving active medication for 48 weeks.

DRUG

PP1M 50 mg eq.

Type= exact number, unit= mg eq., number= 50, form= injection, route= intramuscular use. One injection every month for 48 weeks.

DRUG

PP1M 75 mg eq.

Type= exact number, unit= mg eq., number= 75, form= injection, route= intramuscular use. One injection every month for 48 weeks.

DRUG

PP1M 100 mg eq.

Type= exact number, unit= mg eq., number= 100, form= injection, route= intramuscular use. One injection every month for 48 weeks.

DRUG

PP1M 150 mg eq.

Type= exact number, unit= mg eq., number= 150, form= injection, route= intramuscular use. One injection every month for 48 weeks.

Sponsors & Collaborators

• Janssen Research & Development, LLC

  lead INDUSTRY

Principal Investigators

• Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-05-31

Primary Completion

2015-02-28

Completion

2015-03-31

Countries

• United States
• Argentina
• Australia
• Austria
• Belgium
• Brazil
• Bulgaria
• Canada
• China
• Czechia
• France
• Germany
• Greece
• Hungary
• Japan
• Mexico
• Poland
• Portugal
• Romania
• Russia
• Slovakia
• South Korea
• Spain
• Sweden
• Taiwan
• Ukraine

Study Locations