An Efficacy and Safety Study of Paliperidone Extended-Release (ER) Tablets in Participants With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Paliperidone
Intervention description: Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion will be given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
Intervention MeSH terms: Paliperidone Palmitate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 294.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Schizophrenia; Paliperidone Extended Release (ER); Invega

Summary:

      The purpose of this study is to evaluate the tolerability, safety and treatment response of
      flexible doses of paliperidone extended-release (ER; designed to slowly release a drug in the
      body over an extended period of time) tablets in participants with acute 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:

          -  Meets the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV)
             criteria for schizophrenia

          -  Must be experiencing an acute schizophrenic episode with a Positive and Negative
             Syndrome Scale (PANSS) total score of greater than or equal to 70 at Baseline

          -  Must be admitted to hospital for treatment of the acute schizophrenic episode and must
             agree for voluntary hospitalization for at least the first 7 days of the study

          -  Female participants must be postmenopausal (for at least 1 year), surgically sterile,
             abstinent, or, if sexually active, be practicing and effective method of birth control
             (example, prescription oral contraceptives, contraceptive injections, intrauterine
             device, double-barrier method, contraceptive patch, male partner sterilization) before
             entry and throughout the study and female participants of child-bearing potential must
             have a negative urine pregnancy test at Screening

          -  Participants 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

        Exclusion Criteria:

          -  Pregnant or breast-feeding female participants

          -  First antipsychotic treatment ever

          -  Have received an experimental drug or used an experimental medical device within 30
             days before the planned start of treatment and on clozapine or a long-acting
             injectable antipsychotic during the last 3 months

          -  Known hypersensitivity to paliperidone extended-release (ER) or risperidone

          -  Relevant history of any significant or unstable cardiovascular, respiratory,
             neurologic (including seizures or significant cerebrovascular), renal, hepatic,
             endocrine, or immunologic diseases, history or current symptoms of tardive dyskinesia
             or neuroleptic malignant syndrome including recent or present clinically relevant
             laboratory abnormalities (as deemed by the Investigator) and participants with current
             or known history (over the past 6 months) of substance dependence according to DSM-IV
             Criteria