Prevention of Relapse With Injectable Paliperidone Palmitate Versus Oral Antipsychotics
Condition: Schizophrenia
MeSH terms: Recurrence; Schizophrenia
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      This is a randomized (study drug assigned by chance), open-label (both physician and patient
      know the name of the assigned drug), rater-blinded (the person who assesses the condition of
      the patient does not know the name of the assigned drug), active-controlled, parallel-group,
      multicenter, prospective international study of paliperidone palmitate versus treatment as
      usual with oral antipsychotic agents in monotherapy in the prevention of relapse (return of
      symptoms). Patients who have been recently diagnosed with schizophrenia (within 5 years) and
      are suffering from a schizophrenic relapse (return of symptoms of schizophrenia) will be
      enrolled. This study consists of a 2-week initial acute oral treatment phase, followed by a
      treatment phase (core phase) until relapse or up to maximally 24 months, whichever comes
      first. Prior to a 2-week oral treatment phase, patients will be randomly (by chance) assigned
      in a 1:1 ratio to receive treatment with paliperidone palmitate injection (once-monthly) or
      oral antipsychotic medication (daily). Patients randomized to paliperidone palmitate will
      first receive oral paliperidone ER once daily for 2 weeks followed by paliperidone palmitate
      injections at a dose of 150 mg eq. on Day 1, 100 mg eq. on Day 8 both in the deltoid muscle
      and 75 mg eq. on Day 38 and doses in a dose range of 25 to 150 mg eq. in either the deltoid
      or the gluteal muscle thereafter. Patients randomized to oral comparator arm will receive
      oral antipsychotics (haloperidol, paliperidone ER, risperidone, olanzapine, quetiapine or
      aripiprazole) as per investigator discretion and prescribed according to the label. Total
      treatment duration is maximally 24 months. During the 24 month treatment phase, investigators
      will be allowed to flexibly decrease or increase the dose of paliperidone palmitate with one
      dose level in the range of 25 to 150 mg eq. or the oral antipsychotic in the respective
      locally approved dose range, all according to the patient's clinical needs. The primary
      endpoint of the 24-month treatment phase will be the time to relapse. Safety will be
      monitored by evaluating Adverse Events (AEs), rating of extrapyramidal symptoms (symptoms
      like abnormal muscle movements, abnormal movements of the tongue or jaw, slow or sustained
      muscle contractions, muscle spasms, shaking, abnormal movements of the eyes, involuntary
      muscle contractions, slow movements, or restlessness), vital signs measurements (including
      heart rate and blood pressure), body weight and physical examination findings. A urine
      pregnancy test will be performed in females of childbearing potential. Adverse events
      (unintended, but not necessarily unexpected, results of therapy that can be unpleasant or
      dangerous), associated concomitant medications, and symptoms of relapse will be recorded as
      needed.
    

Intervention name(s): paliperidone palmitate injection; oral antipsychotics
Intervention type(s): Drug; Drug
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; paliperidone palmitate; Invega; Intramuscular injection; Oral antipsychotics; Relapse