Evaluation of Effectiveness and Safety of Paliperidone Extended Release in Patients With Schizoaffective Disorder.
Condition: Schizoaffective Disorder; Psychotic Disorder
MeSH terms: Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to measure the effectiveness and assess the safety of two
      dosages of the antipsychotic paliperidone extended-release (ER) in patients who are
      experiencing an acute episode of schizoaffective disorder.
    

Detailed description: 
      Schizophrenia and schizoaffective disorder are closely related in terms of symptoms,
      coexisting conditions, and genetic risk. In previous studies in patients with schizophrenia,
      treatment with paliperidone extended-release (ER) improved psychotic symptoms, as well as
      mood symptoms evaluated by anxiety/depression and hostility/excitement Positive and Negative
      Symptoms of Schizophrenia (PANSS) factor scores. Therefore, paliperidone ER may also be
      effective in treating symptoms of schizoaffective disorder. Paliperidone's limited potential
      for drug-drug interaction is particularly important in this patient population, in which
      multiple drug therapy is relatively common. This multicenter, double-blind (neither the
      patient nor the physician knows whether drug or placebo is being taken, or at what dosage),
      randomized (patients are assigned different treatments based on chance), placebo-controlled,
      parallel-group study is designed to examine the effectiveness and safety of paliperidone ER
      in adult patients with schizoaffective disorder who are experiencing an acute episode of this
      disorder. Patients in the study will be randomly assigned to 1 of 3 groups to receive 6 weeks
      of oral treatment with 1 of 2 dosages of paliperidone ER or placebo. The primary efficacy
      outcome will be the change from baseline to Week 6, or the last post-randomization assessment
      during double-blind treatment (endpoint), in the PANSS total score. Safety will be assessed
      by monitoring adverse events, clinical laboratory testing, pregnancy testing, vital signs
      measurements, physical examination, administration of a 12-lead ECG, movement disorders side
      effect scales, and the InterSePT Scale for Suicidal Thinking. Patients may also choose to
      participate in a pharmacogenomic (DNA) analysis. The primary study hypotheses are that at
      least one of the two dosages of paliperidone ER is better than placebo on the change from
      baseline in the PANSS total score in acutely ill patients with schizoaffective disorder at
      the end of 6 weeks of treatment. Patients will receive study drug by mouth for a total of 43
      days. Beginning on Day 1, patients will take either placebo or 1 of 2 doses of paliperidone:
      6 mg/day (low randomized dosage) or 12 mg/day (high randomized dosage). During the first 2
      weeks, dosages may be adjusted.
    

Intervention name(s): Paliperidone ER; Paliperidone ER; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 6mg/day paliperidone er for 6 weeks; 12mg/day paliperidone er for 6 weeks; Placebo for 6 weeks
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizoaffective Disorder; antipsychotic; paliperidone; placebo