A Randomized, Open-label Trial of Long-acting Injectable Risperidone Versus Oral Antipsychotic Medication in Patients With Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and effectiveness of a long-acting
      injectable formulation of risperidone in stable bipolar patients randomly switched from their
      current add-on oral antipsychotic (olanzapine, risperidone, or quetiapine) therapy to
      long-acting injectable risperidone. The patients switched to long-acting injectable
      risperidone will be compared to patients who continue on their oral antipsychotic treatment
      regimen
    

Detailed description: 
      This an open-label, randomized study. Approximately 40 stable bipolar patients who are on an
      atypical antipsychotic (olanzapine, risperidone, quetiapine) plus adjunct bipolar treatment
      consisting of (a maximum or two of lithium, valproate or lamotrigine, and, if applicable, one
      antidepressant) will be randomized to two arms. In one arm, 25 milligrams of long-acting
      injectable risperidone will replace the oral atypical antipsychotic as adjunct therapy and in
      the other arm, patients will continue with their current atypical antipsychotic therapy.
      Trial duration is 6 months. In the long-acting injectable risperidone arm, the oral atypical
      antipsychotic will be continued (as supplementation) for 3 weeks after the first injection of
      long-acting risperidone and then discontinued. Investigators, based upon the patient's
      response, may increase the dose of injectable risperidone to 37.5 mg after 6 weeks on the
      25-mg dose and to 50 mg after at least 4 weeks on the 37.5-mg dose. Risperidone oral
      supplementation is allowed. In the oral antipsychotic only arm, the oral atypical
      antipsychotic dose can also be increased as required. The primary efficacy outcome will be
      measured by changes in the Clinical Global Impression - Severity of Illness subscale (CGI-S),
      from baseline to endpoint, and will be compared between the treatment groups. Safety will be
      monitored throughout the study. The primary hypothesis is that patients switched to
      long-acting injectable risperidone will be able to tolerate this formulation of risperidone
      and maintain or even improve their reduction in bipolar symptomatology compared with
      baseline, and compared with subjects who continue in the oral antipsychotic arm. The
      secondary hypothesis is that patients switched to long-acting injectable risperidone will
      have a longer time to intervention for a mood episode (either mania or depression) as
      compared with subjects who continue in the oral antipsychotic arm. Risperidone, formulated
      for intramuscular injection, 25 mg every 2 weeks. Patients treated with injectable
      risperidone continue their original oral atypical antipsychotic (AAP) dose for 3 weeks.
      Investigators, at their discretion, may increase the dose of injectable risperidone to 37.5
      mg after 6 weeks on the 25-mg dose and to 50 mg after at least 4 weeks on the 37.5-mg dose.
      Study duration is 6 months.
    

Intervention name(s): risperidone
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: risperidone; long-acting injectable; bipolar disorder; intramuscular injection