Evaluation of Effectiveness and Safety of Paliperidone ER (Extended-release) Compared With Quetiapine in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy (effectiveness of drug) and safety of
      the antipsychotic paliperidone ER compared to another antipsychotic, quetiapine, and to
      placebo in patients who are acutely ill with symptoms of schizophrenia.
    

Detailed description: 
      This is a randomized (patients are assigned different treatments based on chance), double
      blind (neither the patient nor the physician knows whether drug or placebo is being taken, or
      at what dosage), placebo controlled, parallel group study to compare the efficacy and safety
      of paliperidone ER with quetiapine in the treatment of patients who have schizophrenia and
      are acutely ill. The duration of the study is 42 days. During the first phase (Day 0 - Day
      14) patients receive increasing doses of the treatment to which they are assigned (starting
      with 3mg and increasing to 9 mg or 12 mg of paliperidone ER; starting with 50 mg and
      increasing to 600 mg or 800 mg of quetiapine; or the same number of capsules of placebo).
      During the second phase (Day 15 - Day 42), patients continue to take the dose of medication
      they received on day 14, but may also receive other medications if the investigator
      determines they are needed to treat ongoing symptoms. The hypothesis of the study is that
      paliperidone ER is better than quetiapine in the short term for treating acutely ill patients
      with schizophrenia. Primary outcome is change on the total score of the PANSS (Positive and
      Negative Syndrome scale for Schizophrenia) in the first phase of the study (Day 0 - Day 14).
      Secondary outcomes include time to response, time to readiness for discharge, and additional
      medication use in the second phase of the study (Day 15- Day 42) for patients receiving
      paliperidone ER compared to quetiapine. Safety of paliperidone ER compared with quetiapine
      throughout the study (Day 0 - Day 42) will be based on reported adverse events, results of
      laboratory tests (hematology, biochemistry, and urinalysis), vital signs (blood pressure,
      pulse, and weight), electrocardiogram, and movement disorder scales (Abnormal Involuntary
      Movement Scale, Barnes Akathisia Scale, and Simpson-Angus Rating Scale). Patients may
      participate in a pharmacogenomic (DNA) analysis, if they choose to do so. Patients receive
      study drug by mouth for a total of 42 days. Study medications will be increased to maximum
      tolerated doses of Paliperidone ER 9mg or 12mg/day and Quetiapine 600mg or 800mg at day 8.
      From day 15 through day 42 (end of study) all patients will be eligible for additional
      psychotropic medications at investigators' discretion.
    

Intervention name(s): paliperidone ER tablets, quetiapine tablets, placebo - all over encapsulated
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate; Paliperidone Palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Schizophrenia; Antipsychotic; paliperidone; quetiapine; Seroquel; placebo