An Efficacy, Safety And Tolerability Study of Flexibly Dosed Paliperidone Extended-Release (ER) in Participants With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Paliperidone ER
Intervention description: Participants will receive paliperidone ER tablet in dose range of 3 to12 milligram (mg) per day orally once daily for 24 weeks as per Investigator's discretion based on the individual participant's clinical response to and tolerability of the study drug.
Intervention MeSH terms: Paliperidone Palmitate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 299.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Schizophrenia; Paliperidone Extended-Release

Summary:

      The purpose of the study is to explore the maintained efficacy, tolerability, and safety 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) previously unsuccessfully
      treated with other oral atypical antipsychotic medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant meets the Diagnostic and Statistical Manual of Mental Disorders, Fourth
             Edition (DSM-IV) criteria for schizophrenia

          -  Participant has been given an adequate dose of an appropriate oral atypical
             antipsychotic for an adequate period of time prior to enrollment, but previous
             treatment is considered unsuccessful due to one or more of the following reasons: lack
             of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons
             to switch to another antipsychotic medication

          -  Participant or their legally acceptable representatives must have signed an informed
             consent document indicating that they understand the purpose of and procedures
             required for the study and are willing to participate in the study

          -  Female participants must be postmenopausal for at least 1 year, surgically sterile,
             abstinent, or, if sexually active, agree to practice an effective method of birth
             control before entry and throughout the study and must also have a negative urine
             pregnancy test at screening

          -  Male or female, aged greater than or equal to 18 years

        Exclusion Criteria:

          -  Participants on clozapine, any conventional depot neuroleptic or Risperdal CONSTA
             during the last 3 months

          -  Participants with serious unstable medical condition, including known clinically
             relevant laboratory abnormalities

          -  Participants with history or current symptoms of tardive dyskinesia (twitching or
             jerking movements that you cannot control in your face, tongue, or other parts of your
             body)

          -  Participants with history of neuroleptic malignant syndrome (high fever, rigid
             muscles, shaking, confusion, sweating more than usual, increased heart rate or blood
             pressure, or muscle pain or weakness)

          -  Participants with a current use or known history (over the past 6 months) of substance
             dependence except for nicotine, caffeine, and betal nut according to DSM-IV Criteria