PaliperidoNe Extended-Release [ER] Dosing and Clinical Response in Acute Schizophrenia (PANDORA)

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Paliperidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00761189

CR015079

PAL-KOR-4001

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of paliperidone extended-release (ER) 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), single arm, and non-comparative study of paliperidone Extended Release(ER) in participants with schizophrenia. The total study duration will be approximately of 104 weeks per participant. The study consists of following parts: Screening (that is, 14 days before study commences on Day 1); acute Treatment phase (single-oral dose of paliperidone for 12 weeks, dose ranging from 3 to 12 milligram); Extension phase 1 (12 weeks) and Maintenance treatment which will be followed by additional Extension phase 2 and long-term maintenance treatment. Efficacy of the participants will primarily be evaluated by Clinical Global Impression-Improvement (CGI-I) scale score. Participants' safety will be monitored throughout the study.

Enrollment: 491 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with Clinical Global Impression-Severity (CGI-S) score greater than or equal to 4 points (moderately ill) at Screening
• Childbearing potential women who consent to the consistent use of the acceptable contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
• Participants who are capable of and willing to fill out the questionnaire for themselves
• Participants who are compliant with self-medication or can receive consistent help or support
• Have schizophrenia diagnosis by Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)

Exclusion criteria

• Participants with the past history of neuroleptic malignant syndrome (NMS)
• Participants with Treatment Resistance history who have failed to be properly treated with more than two other kinds of antipsychotic agents (at least 4 weeks of the therapeutic dose administration)
• Participants with severe (pathologic or iatrogenic) gastrointestinal stenosis or participants who can not 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 who have been exposed to the study drug within one month before screening
• Participants with significant risk including suicide or aggressive behavior

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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491 participants in 1 patient group

Paliperidone

Experimental group

Description:

Paliperidone extended-release (ER) tablet will be administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.

Treatment:

Drug: Paliperidone