A Study of Effectiveness and Safety of Risperdal CONSTA Added to Usual Treatment in Patients With Bipolar Disorder Who Have Frequent Mood Episodes.
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine the safety and effectiveness of the long acting
      injectable form of the atypical antipsychotic Risperidone (Risperdal CONSTA), along with
      treatment as usual (TAU), in bipolar disorder patients who had more than 4 mood episodes in
      the past year.
    

Detailed description: 
      Frequently-relapsing (more than 4 episodes in the last year) bipolar patients are a sub-group
      of patients who have multiple mood episodes in spite of treatment. Currently available
      treatments may have little impact on number and frequency of manic and/or depressed mood
      episodes and as a result, these patients have higher than average rates of illness and death.
      This study examines the effectiveness and side effects of risperidone long-acting injections
      (LAI) added to treatment as usual (TAU) in frequently-relapsing bipolar patients. The study
      has two main phases. The first phase is open-label (patients and doctors know what medication
      and dose the patient is receiving- both risperidone LAI and TAU) and lasts 16 weeks. During
      that time, patients are treated with the goal that they reach "remission", a predefined level
      of improvement (decrease in number and severity of mood episodes.) Patients who meet
      remission criteria at the end of the first phase are randomized (like flipping a coin) to
      either continue receiving the same dose of risperidone LAI plus TAU, or placebo injections
      plus TAU. Patients continue in the second phase for 52 weeks, during which time the
      effectiveness is measured by time to "relapse" (worsening of mood symptoms severe enough to
      require hospitalization or a major change in medication.) Additional effectiveness, safety,
      and side effect measures are evaluated throughout the length of the study.

      Long-acting risperidone injection 25 mg will be administered every two weeks through a
      gluteal injection for at least one month. Thereafter, the dose may be increased to 37.5mg
      then to 50 mg based on clinical response and tolerability. Supplemental use of oral Risperdal
      (1 to 2 mg/day) will be permitted during the first 12 weeks of the Open-Label Stabilization
      Phase. Patients must be taking a stable dose of risperidone LAI for the 4 weeks immediately
      prior to entering the Double-Blind Phase.
    

Intervention name(s): Risperdal Consta; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 25, 37.5 or 50mg IM injections every 2wks for 52wks; matching placebo IM injections every 2wks for 52wks
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Risperidal CONSTA; Bipolar disorder; mood episodes; Safety and efficacy, adjuvant therapy