Evaluation of Effectiveness and Safety of Flexible-dose 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 different
      dosages (from 3 mg/day to 12 mg/day) 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 2 groups to receive 6 weeks
      of oral treatment with flexible dosages of paliperidone ER (3-12 mg/day) or with 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 hypothesis is that flexible-dose paliperidone ER is better than placebo on the
      change from baseline in the PANSS total score in acutely ill patients with schizoaffective
      disorder. Patients will receive study drug by mouth for a total of 43 days. Beginning on Day
      1, patients will take either placebo or paliperidone ER 6 mg/day. After day 4, dosages may be
      adjusted, at defined intervals, to a dosage between 3 mg/day and 12 mg/day, inclusive.
    

Intervention name(s): Placebo; Paliperidone ER; Paliperidone ER
Intervention type(s): Drug; Drug; Drug
Intervention description(s): for 6 weeks; (3-12mg/day in 3 mg/day increments for 6 weeks); (3-12mg/day in 3 mg/day increments 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