Long-acting Injectable Risperidone in Patients With Schizophrenia After an Acute Episode
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this randomized trial was to investigate whether early initiation of
      treatment with Risperdal Consta after an acute episode was not inferior to the routine
      approach (oral treatment for 12 weeks followed by treatment with Risperdal Consta). .
    

Detailed description: 
      Although many schizophrenia patients currently take oral antipsychotic medications, it is
      estimated that up to 75% of them have difficulty adhering to the daily oral regiment.
      Long-acting injectable formulations may eliminate the need for daily medication and enhance
      patient compliance with the treatment regimen. Traditionally, patients experiencing an
      episode of schizophrenia are first treated with oral medications until they are stabilized,
      and then injectable long-acting formulations are given. This is an open, multicenter,
      randomized Phase IV trial in patients after an acute episode of schizophrenia. Patients will
      be in the trial for 6 months. One treatment group will receive injections starting at
      baseline (early initiation); the other group will start with treatment as usual at baseline
      and begin injections at Week 12 (late initiation). Assessment of effectiveness include
      Positive And Negative Syndrome Scale (PANSS), in order to measure symptoms of schizophrenia;
      Clinical Global Impression - Severity (CGI-S), measuring overall severity of illness; Global
      Assessment of Functioning (GAF), assessesing overall psychological, social, and occupational
      functioning; and Quality of Life Questionnaire SF-12, measuring overall health status. Safety
      evaluations include the Extrapyramidal Symptoms Rating Scale (ESRS), incidence of adverse
      events throughout the study, and vital signs (pulse, blood pressure). The study hypothesis is
      that early initiation of long-acting risperidone injections is not inferior to late
      initiation as measured by changes in PANSS total score from baseline through endpoint (after
      6 months). Risperidone, long-acting formulation for intramuscular injections (25 to 50 mg
      (maximum)), given every 14 days through 6 months, starting at baseline or Month 3. Treatment
      as usual for 3 months for late initiation group
    

Intervention name(s): early initiation of treatment with Risperdal Consta; routine initiation of treatment with Risperdal Consta
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg to 50 mg Risperdal Consta intrmuscular injection every 14 days starting at baseline. Treatment with oral antipsychotics or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.; 25 mg to 50 mg Risperdal Consta intrmuscular injection every 14 days starting at week 12. Treatment with oral antipsychotics or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; intramuscular injection; antipsychotic agents; long-acting risperidone