An Efficacy Study of Paliperidone for the Prevention of Relapse in Participants With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Paliperidone; Placebo
Intervention description: Paliperidone extended-release (ER) oral tablet will be administered at a starting dose of 3 milligram (mg) up to 12 mg once daily for 8 weeks in Run-in or Stabilization phase, and 3-12 mg fixed dose oral tablet will be administered in DB phase. Participants who will enter open-label extension phase will receive paliperidone as 3-12 mg per day.; Participants who transitioned from run-in or stabilization phase will receive matching placebo to paliperidone ER once daily during DB phase of the study.
Intervention MeSH terms: Paliperidone Palmitate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 201.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Schizophrenia; Paliperidone; Paliperidone Extended-Release

Summary:

      The purpose of this study is to evaluate the efficacy, tolerability and safety of
      paliperidone extended release (ER) tablets (between 3 to 12 milligram (mg), once a day) in
      the prevention of relapse in schizophrenia participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of schizophrenia according to Diagnostic and Statistical Manual of
             Mental Disorders, 4th Edition (DSM-IV)

          -  Have experienced an acute episode, with a Positive and Negative Syndrome Scale (PANSS)
             total score between 70 and 120 inclusive, at Screening and Baseline

          -  Women must be postmenopausal (for at least 1 year), surgically sterile (have had a
             hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of
             pregnancy), practicing a highly effective method of birth control, if sexually active

          -  Men must be using a highly effective method of birth control and must not donate sperm
             during the study and for 3 months after receiving the last dose of study drug

          -  Be willing and capable to complete the questionnaires and able to take oral
             medications independently

        Exclusion Criteria:

          -  Has drug dependence diagnosis according to DSM-IV (excluding nicotine and caffeine
             dependence) within 6 months before screening

          -  Participants with Crohn's disease and hepatic or renal diseases

          -  Has had relevant history of any significant and/or unstable cardiovascular,
             respiratory, neurologic (including seizures or significant cerebrovascular
             dysfunction), renal, hepatic, endocrine, or immunologic diseases

          -  Has had history of neuroleptic malignant syndrome (the disorder caused by
             antipsychotic drugs with symptoms of fever, muscle rigidity and delirium)

          -  Has had known or suspected Stevens Johnson Syndrome (an immune disease with symptoms
             of fever, sore throat, ulcers and conjunctivitis) after exposure to phenytoin,
             carbamazepine, barbiturates, or lamotrigine

          -  Had been treated with clozapine for treatment refractory or treatment resistant
             schizophrenia

          -  Has significant risk of suicide or homicidal behavior, or significant risk of
             deliberate self harm or harm to others

          -  Has taken isocarboxazid, phenelzine, selegiline and tranylcypromine within 4 weeks
             before screening

          -  Has received electroconvulsive therapy within 60 days before screening