Prevention of Relapse With Injectable Paliperidone Palmitate Versus Oral Antipsychotics
Condition: Schizophrenia
MeSH terms: Recurrence; Schizophrenia
Intervention: paliperidone palmitate injection; oral antipsychotics
Intervention description: injection with 150 mg equivalent on Day 1, 100 mg equivalent on Day 8, 75 mg equivalent on Day 38 and flexible dosing with 25, 50, 75, 100 or 150 mg equivalent once monthly thereafter; daily treatment according to local label for maximally 24 months
Intervention MeSH terms: Paliperidone Palmitate; Antipsychotic Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 769.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; paliperidone palmitate; Invega; Intramuscular injection; Oral antipsychotics; Relapse

Summary:

      The purpose of this study is to assess the efficacy (how well the drug works; primarily
      through the time to relapse) of long-acting injectable paliperidone palmitate compared to
      treatment as usual with orally administered antipsychotics in monotherapy over 24 months in
      the treatment of recently diagnosed (1-5 years since diagnosis) schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have been meeting the diagnostic criteria for schizophrenia for 1 to 5 years before
             screening, and have a history of treatment with antipsychotics

          -  Have a history of two or more relapses requiring psychiatric hospitalization in the
             preceding 24 months, which may include the current acute episode

          -  Experiencing at screening an acute schizophrenic episode with a Positive And Negative
             Syndrome Scale (PANSS) total score at screening between 70 and 120, inclusive

          -  Be healthy on the basis of physical examination, medical history and vital signs
             performed at screening

          -  Woman must be postmenopausal (for at least 1 year) or surgically sterile or abstinent
             or be practicing an effective method of birth control, must agree to continue to use
             the same method of contraception throughout the study and must have a negative urine
             pregnancy test at screening

          -  be able to fill out questionnaires

          -  Men must agree to use a double barrier method of birth control and to not donate sperm
             during the study and for 3 months after receiving the last dose of study drug

        Exclusion Criteria:

          -  Patients that have never been treated with antipsychotics before

          -  Treatment resistant patient and/or currently (i.within the last 3 months) treated with
             clozapine

          -  Substance dependence within 6 months prior to entry and current intravenous drug use
             or abuse

          -  allergies, hypersensitivity, or intolerance to risperidone or paliperidone or
             excipients

          -  treatment with a long-acting injectable antipsychotic within three injection cycles
             prior to screening

          -  newly started psychotherapy program within the two months preceding the treatment
             phase baseline

          -  evidence of clinically significant hepatic, renal, cardiac, vascular, pulmonary,
             gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or
             metabolic disturbances in the past 6 months (as determined by medical history,
             clinical laboratory or ECG results, or physical examination) that would increase the
             risk associated with taking study medication or would confound the interpretation of
             the study

          -  history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome

          -  involuntarily hospitalized patient

          -  pregnant or breast-feeding females