A Study to Evaluate Participants Satisfaction, Quality of Life and Effectiveness of Flexible-Dose of Paliperidone Extended Release (ER) in Participants With Schizophrenia, Previously Treated With Risperidone
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Paliperidone Extended Release (ER)
Intervention description: Paliperidone ER tablets in the flexible dose ranging from 3 to 12 mg will be administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator's discretion.
Intervention MeSH terms: Paliperidone Palmitate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 223.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Schizophrenia; Paliperidone

Summary:

      The purpose of this study is to evaluate effectiveness, tolerability (how well a participant
      can stand a particular medicine or treatment), and safety of flexible-dose 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), previously taking risperidone (an antipsychotic), but who are
      not satisfied with their treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female participants must be postmenopausal (after the time in life when a woman stops
             having a menstrual period) or surgically sterile or if sexually active, practicing an
             effective method of birth control (e.g., oral contraceptive, intrauterine device [IUD
             - an intrauterine device made of plastic and/or copper that is inserted into the womb
             [uterus] by way of the vaginal canal to used to prevent pregnancy], diaphragm with
             spermicide [agent that kills spermatozoa] or condom [cover worn over the penis during
             sexual intercourse to prevent infection or pregnancy] with spermicide) throughout the
             study and have a negative serum beta - Human Chorionic Gonadotropin (HCG) pregnancy
             test at screening

          -  Participants on oral monotherapy (treatment with a single drug) with risperidone in a
             regimen within the daily dosage recommended by the package insert and adhering to the
             prescribed risperidone regimen for at least 30 days before entering the study

          -  Participants with partial response to the current risperidone regimen (persistent
             symptoms or unstable clinical condition) or presence of unbearable side effects

          -  Potential Participants switching to another atypical antipsychotic due to their
             clinical response and/or side effects profile.

        Exclusion Criteria:

          -  Participants with past or current history of psychiatric disease other than
             schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders
             (DSM)-IV

          -  Participants with concomitant (given at the same time) severe (very serious, life
             threatening) medical or neurological disorder or risk of suicide

          -  Participants previously using clozapine

          -  Participants with a history of previous non-responsiveness to oral antipsychotic
             treatment

          -  Pregnant or breast-feeding female participants