NCT01592201

A Comparative Study of Patient Satisfaction Between Continued Administration of Previous Antipsychotics Versus Switched Administration to Paliperidone ER in Non-satisfied Patients With Previous Antipsychotic Drug

An Open-label, Prospective, Randomized and Comparative Study of Patient Satisfaction Between Continued Administration of Previous Antipsychotics Versus Switched Administration to Paliperidone ER in Non-satisfied Patients With Previous Antipsychotic Drug

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Janssen Korea, Ltd., Korea · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the patient satisfaction between continued administration of previous antipsychotics versus switched administration to paliperidone ER in non-satisfied patients with previous (paliperidone)

Detailed description

This is a randomized (patients are assigned to intervention by chance), prospective, open-label (all people involved know the identity of the assigned drug), switch study designed to evaluate patient-assessed medication satisfaction after 12 weeks of treatment in patients with schizophrenia. The total duration of this study is 12 weeks. Outpatients who treated atypical antipsychotics and report dissatisfaction (Medication Satisfaction Questionnaire \[MSQ\] \<4) with their current treatment response are eligible to participate in the study. Patients will be randomized into two groups, 1) Patients randomized to an immediate initiation of paliperidone ER for a total 12 weeks 2) Patients randomized to a delayed initiation will continue their previous atypical antipsychotics for 8 weeks and then be initiated on paliperidone ER at Day 56 for 4 weeks. During the study treatment optimization will be done by dose adjustment (dose increase or decrease) and by adding psychotropic agents except the antipsychotics.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Paliperdidone ER	Form = osmotic release oral system, route = oral
DRUG	Aripiprazole, olanzapine and risperidone (Antipsychotics)	Form = tablet, route = oral

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2012-05-07
• Last updated: 2014-06-25

Locations

9 sites across 1 country: South Korea