Efficacy Study of Paliperidone to Evaluate Subjective Change in Well-being and Drug Attitude in Schizophrenic Participants
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Paliperidone
Intervention description: Paliperidone 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.
Intervention MeSH terms: Paliperidone Palmitate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 289.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; Paliperidone Extended-release; Paliperidone; R076477

Summary:

      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).
    

Eligibility criteria:

        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