Paliperidone Extended Release in Schizophrenia Participants With Duration of Illness Less Than 10 Years
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Paliperidone ER
Intervention description: Participants will be administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose will be increased or decreased as per 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: 133.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Schizophrenia; Paliperidone

Summary:

      The purpose of this study is to evaluate the effectiveness and safety of paliperidone
      extended release (ER) in symptomatic participants with schizophrenia (psychiatric disorder
      with symptoms of emotional instability, detachment from reality, often with delusions and
      hallucinations, and withdrawal into the self) who were receiving treatment with any oral
      (having to do with the mouth) antipsychotic medication and who needed to be switched to
      paliperidone ER from the current oral antipsychotic therapy due to insufficient efficacy or
      due to side effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants meet the Diagnostic and Statistical Manual of Mental Disorders Fourth
             Edition (DSM-IV) criteria for schizophrenia (psychiatric disorder with symptoms of
             emotional instability, detachment from reality, often with delusions and
             hallucinations, and withdrawal into the self)

          -  Positive and Negative Syndrome Scale (PANSS) total score at Baseline of greater than
             equal to 70 and less than equal to 100

          -  Participants who need to be switched from the current oral antipsychotic therapy
             because of lack of efficacy or side effects

          -  Participants followed as outpatients

          -  Female participants must be postmenopausal for at least 1 year, surgically sterile or,
             if sexually active, be practicing an effective method of birth control and female
             participants of childbearing potential must also have a negative urine pregnancy test
             at Baseline

        Exclusion Criteria:

          -  Acute psychotic relapse that requires hospitalization and first antipsychotic
             treatment ever

          -  Participants who had received clozapine during the previous 3 months

          -  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) and neuroleptic
             malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than
             usual, increased heart rate or blood pressure, or muscle pain or weakness)

          -  Pregnant or breast-feeding female

          -  Participated in an investigational drug trial in the previous 30 days