Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: RISPERDAL CONSTA; Paliperidone palmitate
Intervention description: RISPERDAL CONSTA: Type=exact number, unit=mg, number=25, 37.5, or 50, form=suspension for injection, route=Intramuscular use. One i.m. injection of RISPERDAL CONSTA 25-50 mg eq every 2 weeks at V4, V6, V7, V8, V9, and V10. PALIPERIDONE PALMITATE PLACEBO: Form=suspension for injection, route=Intramuscular use. One i.m. injection every 2 weeks at Baseline and at V4, V7, and V9. RISPERIDONE: Type=up to, unit=mg, number=1 to 6, form=Tablet, route=Oral Use. One tablet for the first 4 weeks (28 days) of the DB treatment period.; PALIPERIDONE PALMITATE: Type=exact number, unit=mg, number=50, 100, or 150, form=suspension for injection, route=Intramuscular use. One i.m. injection of Paliperidone palmitate 50-150 mg eq every 4 wks at Baseline, V4, V7, and V9. RISPERDAL CONSTA PLACEBO: Form=suspension for injection, route=Intramuscular use. One i.m. injection every 4 weeks at Baseline, V4, V7, and V9.
Intervention MeSH terms: Paliperidone Palmitate; Risperidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1221.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Schizophrenia; long-acting injectable antipsychotic medication

Summary:

      The purpose of this study is to demonstrate the effectiveness of paliperidone palmitate in
      patients with Schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet diagnostic criteria for schizophrenia according to Diagnostic and Statistical
             Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria as specified by the
             protocol for at least 1 year before screening

          -  Prior medical records, written documentation or verbal information obtained from
             previous psychiatric providers obtained by the investigator must be consistent with
             the diagnosis of schizophrenia

          -  A total PANSS score between 60 and 120, inclusive, at screening and baseline; Body
             mass index (BMI) at the screening visit BMI at least 17 kg/m2

          -  Female patients must be postmenopausal for at least 2 years, surgically sterile,
             abstinent, or, if sexually active, be practicing an effective method of birth control
             before study entry and throughout the study as specified by the protocol. Women of
             childbearing potential must have a negative serum beta-human chorionic gonadotropin (b
             hCG) pregnancy test result at screening.

        Exclusion Criteria:

          -  Patient unable to provide consent or involuntarily committed to psychiatric
             hospitalization; A primary, active DSM-IV diagnosis on Axis I other than schizophrenia

          -  A DSM-IV diagnosis of active substance dependence within 3 months before screening
             (nicotine and caffeine are not exclusionary)

          -  History of treatment resistance as defined by failure to respond to 2 adequate
             treatments with different antipsychotic medications (an adequate treatment is defined
             as a minimum of 6 weeks at maximum tolerated dosage)

          -  Relevant history or current presence of any significant or unstable cardiovascular,
             respiratory, neurologic (including seizures or significant cerebrovascular disease),
             renal, hepatic, hematologic, endocrine, immunologic, or other systemic disease
             including history of neuroleptic malignant syndrome; History of any severe
             pre-existing gastrointestinal narrowing or inability to swallow oral study drug whole
             with the aid of water (applies to those patients requiring oral tolerability only)

          -  Significant risk of suicidal or violent behavior, as clinically assessed by the
             investigator ; History of life-threatening allergic reaction to any drug; Known or
             suspected hypersensitivity or intolerance to risperidone, paliperidone, 20%
             Intralipid, or any of their excipients (e.g., soybean oil, egg yolks, phospholipids,
             and glycerol)

          -  Have received an experimental drug or experimental biologic, or used an experimental
             medical device within 6 months before screening; History of any active malignancy
             within the previous 5 years, with the exception of basal cell carcinomas

          -  Women who are pregnant or breast-feeding or are planning to become pregnant uring the
             study