Risperdal Consta for Bipolar Disorder
Condition: Bipolar I Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      We recruited 50 consenting adult subjects with DSM-IV TR diagnoses of bipolar disorder who
      were about to initiate or switch their current antipsychotic agent. Only 48 patients (23 in
      the risperidone LAI group and 25 in the oral AAP group) contributed data to the assessments.
      Patients were titrated and cross-tapered during a 3 month titration and stabilization phase.
      They were followed for an additional 12 months. Clinical outcomes such as study drop out,
      adverse events, worsening of symptoms, crisis interventions, need for additional medication,
      hospitalizations etc. were evaluated from months 3 to 15. The numbers of clinical events
      (pooled) will be used to evaluate if the long acting injectable form of risperidone has an
      advantage over the oral second generation antipsychotic agents in terms of treatment
      continuity and clinical stability.
    

Detailed description: 
      OBJECTIVE:

      To evaluate if a long acting injectable form of risperidone offers clinical advantages over
      comparison oral second generation antipsychotic agents following titration and stabilization
      in bipolar subjects. In keeping with current practice, it is expected the vast majority of
      patients will also be receiving either lithium or valproate or other anticonvulsants.
      Following the stabilization phase several clinical events will be evaluated for up to 15
      months in the two treatment groups to examine differences in clinical outcomes between those
      receiving the injectable versus oral medicines.

      RESEARCH PLAN:

      We intend to recruit 50 consenting adult subjects with DSM-IV TR diagnoses of bipolar
      disorder who are about to initiate or to switch their antipsychotic agent. Patients will be
      titrated and cross-tapered during a 3 month titration and stabilization phase. Those who
      transition successfully and show some improvement will be followed for an additional 12
      months. Clinical outcomes such as study drop out, adverse events, worsening of symptoms,
      crisis interventions, need for additional medication, hospitalizations etc. will be evaluated
      from months 3 to 15. The numbers of clinical events (pooled) will be used to evaluate if the
      long acting injectable form of risperidone has an advantage over the oral second generation
      antipsychotic agents in terms of treatment continuity and clinical stability.

      METHODS:

      An open design, but treatment to either the long acting risperidone or to the oral second
      generation antipsychotic agents is randomly assigned. A board independent of the day-to-day
      clinical events will code the primary clinical outcomes of interest without knowledge of
      treatment assignment. The board will be provided clinical summaries of these events without
      revealing the treatment assignment.

      SIGNIFICANCE:

      The use of a long acting injectable second generation antipsychotic agent may offer
      advantages of treatment continuity and adherence in bipolar patients permitting improved
      clinical stability and improved psychosocial and functional outcomes. Such stability is
      difficult to achieve in the face of frequent treatment discontinuations seen with oral
      agents. The improved tolerability of the second generation antipsychotic agents may change
      the perception of long acting injections. For instance, these agents are likely to be more
      acceptable to patients, families and clinicians and therefore likely be used much sooner in
      the treatment algorithms of bipolar patients than in the past. This study will provide a
      treatment effect size to statistically power future comparisons of long-acting injectable vs.
      oral antipsychotic agents in persons with bipolar disorder
    

Intervention name(s): Injectable Risperidone (Consta) or oral antipsychotic
Intervention type(s): Drug
Intervention description(s): Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks
Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder
Other intervention name(s): Long actiing risperidone injection (Consta), oral risperidone (risperdal).; Olanzapine (Zyprexa), Quetiapine (Seroquel), Ziprasidone (Geodon), Aripiprazole (Ablify)
Intervention MeSH terms: Olanzapine; Risperidone; Aripiprazole; Quetiapine Fumarate; Ziprasidone; Antipsychotic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar I Disorder; Risperidone Consta - Long Acting Injection; Oral second generation antipsychotic agents