Efficacy Study of Paliperidone to Evaluate Subjective Change in Well-being and Drug Attitude in Schizophrenic Participants (Power)

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Paliperidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00784238

R076477SCH4028

CR015391

Details and patient eligibility

About

The purpose of this study is to evaluate improvement and efficacy of paliperidone extended-release for subjective well-being and drug attitudes of participants, when switching from oral antipsychotics in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

Full description

This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center), prospective (study following participants forward in time), and non-comparative study, in participants with schizophrenia. The study consists of following parts: Screening (that is, 14 days before study commences on Day 1); Acute Treatment phase (24 weeks); Extension phase 1 (24 weeks), which will be followed by additional Extension phase 2 (48 weeks). Total study duration per participant will be 96 weeks. Efficacy will primarily be evaluated by change from Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale score and change from Baseline in Drug Attitude Inventory scores. Participants' safety will be monitored throughout the study.

Enrollment: 289 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who are diagnosed with schizophrenia (diagnosis criteria: Diagnostic and Statistical Manual of Mental Disorders, fourth edition [DSM-IV])
• Participants who need to change the antipsychotic drug to another one for the following reasons among the participants treated with an antipsychotic drug for more than two weeks before the screening-Lack of efficacy, lack of tolerance or lack of compliance
• Participants who are capable of and willing to fill out the questionnaire for themselves
• Childbearing potential women who consent to the use of the consistently permissible contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
• Participants who are compliant with self-medication or can receive consistent help or support

Exclusion criteria

• Participants with the past history of neuroleptic malignant syndrome (NMS), or with allergy or hypersensitivity to risperidone or paliperidone
• Participants who have taken clozapine within one month before screening
• Participants who are suspicious of having clinically significant risk including suicide or aggressive behavior and are expected to unable to complete the study (based on the investigator's judgment)
• Participants with severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or participants who cannot swallow the drug whole (The study drug must not be chewed, divided, melted or grinded because it can impact the study drug release profile)
• Participants with a known or suspected history (for 6 months and longer) of substance dependence according to the DSM-IV criteria

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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289 participants in 1 patient group

Paliperidone

Experimental group

Description:

Paliperidone Extended-Release (ER) oral tablet will be administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range will be 3 to 12 mg per day.

Treatment:

Drug: Paliperidone