NCT01947803

A Safety and Effectiveness Study of Paliperidone Palmitate in Chinese Patients With Schizophrenia

Safety and Effectiveness of Paliperidone Palmitate in 25-week Treatment on Chinese Patients With Schizophrenia: an Open-label, Single-arm, Multicenter Prospective Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 353 (actual)
• Sponsor: Xian-Janssen Pharmaceutical Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study will be to evaluate the safety and treatment response of paliperidone palmitate administered to Chinese patients with schizophrenia.

Detailed description

This study is a single-group, open-label (name of study drug is known to patients), multicenter study to evaluate the safety and efficacy/treatment response of paliperidone palmitate administered for 25 weeks as once-monthly injections to Chinese patients with schizophrenia who previously received treatment with oral antipsychotic medications. A target of 353 patients (inpatients or outpatients) with schizophrenia will be enrolled in the study and will receive injections of study drug (paliperidone palmitate) on Days 1 and 8, and thereafter at a monthly flexible dose, based on patients' tolerability and/or efficacy. The study will consist of a screening period of up to 1 week before treatment, a 25-week treatment period, and a follow-up period approximately 30 days after the last injection of study drug. Upon meeting the entry criteria for the study, patients will receive a total of 8 intramuscular (IM) injections of paliperidone palmitate during the treatment period as follows: 150 mg equivalent (eq) on Day 1, 100 mg eq on Day 8, and subsequent monthly IM injections with a flexible dose range of 75-150 mg eq. If the patient reports any signs or symptoms of worsening of schizophrenia, the investigator may prescribe a rescue medication (quick-relief or fast-acting medications that usually work right away to relieve symptoms) such as lorazepam (an antianxiety drug) to control agitation, irritability, restlessness, and hostility. Safety will be monitored throughout the study.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Paliperidone Palmitate	Paliperidone Palmitate is injected with a dose of 150 mg eq. on Day 1 and 100 mg eq. on Day 8 in the deltoid muscle, followed by a monthly flexible dose range of 75 - 150 mg eq. for injection, based on patients' tolerability and/or efficacy. Monthly doses can be administered in either the deltoid or gluteal muscle alternatively. All the antipsychotics should be discontinued prior to the first dose of study drug. Other antipsychotics are prohibited across this study.

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2013-09-20
• Last updated: 2016-03-14

Locations

12 sites across 1 country: China