Paliperidone Extended Release(ER) Effectiveness Study to Evaluate the Objective Symptom Change and Symptomatic Remission
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Paliperidone
Intervention description: Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg), 6 mg or 9 mg for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day.
Intervention MeSH terms: Paliperidone Palmitate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 190.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; Paliperidone; Antipsychotics Agents

Summary:

      The purpose of this study is to investigate the safety and efficacy of flexibly dosed
      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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

          -  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 (1) Group of lack of efficacy: the antipsychotic
             drug is clinically required to be changed because there is no or little therapeutic
             response despite the appropriately dosed antipsychotic therapy (2) Group of lack of
             tolerance: the antipsychotic drug is required to be changed due to lack of tolerance
             to the existing antipsychotic drug or the safety issue (3) Group of lack of
             compliance: the antipsychotic drug is required to be changed due to lack of medication
             compliance or the participant wants to change the antipsychotic drug)

          -  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 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 significant abnormal findings in blood chemistry, hematological and
             urine analyses which are clinically significant at the investigator's discretion

          -  Female Participants who are pregnant or are breast feeding