Does Risperidone Consta Reduce Relapse and Rehospitalization in Bipolar Disorder?
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the relative effectiveness of risperidone Consta injections
      occurring every 2 weeks in contrast to treatment as usual in preventing symptomatic relapse
      and rates of rehospitalization or admission into respite care for bipolar patients.

      Hypothesis: Risperdal Consta injections every 2 weeks will reduce the number of symptomatic
      relapses into mania, hypomania, mixed state, or depression, as shown by key indicators that
      include symptomatic relapse, rehospitalizations, emergency or urgent care visits, respite
      care, and intensive outpatient treatment as compared to treatment as usual.
    

Detailed description: 
      Bipolar disorder arguably represents the most difficult to treat of all psychiatric
      disorders. In fact, long-term stabilization is more the exception than the rule, and the
      majority of patients experience frequent relapses of illness. Studies have shown that both
      bipolar I and II patients spend about half of their weeks in a significant symptomatic state.
      Relapses and persistent illness result in substantial morbidity, mortality, and disability.

      Symptomatic recurrences happen as a result of breakthrough symptoms during active treatment
      and intermittent non-adherence. Therefore, enhanced control of symptoms, coupled with ensured
      adherence, is very likely to improve the long-term outcome of this difficult-to-treat
      condition.

      Risperidone has been shown to be effective in controlling symptoms of acute mania or mixed
      state in two registration monotherapy and one combination treatment study with lithium or
      valproate, as well as several smaller trials. However, longer-term treatment studies are
      relatively lacking. As well, although Risperdal Consta(TM) has been shown to be of benefit in
      prevention of relapse in patients with schizophrenia, relatively little longer-term data in
      bipolar disorder is available. Nonetheless, both risperidone and Risperdal Consta (TM) are
      likely to be highly efficacious for the maintenance prevention of relapse in bipolar
      disorder. Moreover, Risperdal Consta(TM) helps to ensure longer-term treatment effectiveness,
      both by better adherence and improved control of symptoms. The present study is intended to
      determine whether Risperdal Consta(TM) injections, added to ongoing pharmacotherapy, will
      improve outcome relative to treatment as usual.
    

Intervention name(s): Risperdal (risperidone) Consta; Treatment as usual
Intervention type(s): Drug; Drug
Intervention description(s): Risperdal Consta (TM) will be administered every 2 weeks by deep intramuscular (IM) gluteal injection, by a trained health care professional. Injections will alternate between the two buttocks. The initial dose will be 25 mg IM every 2 weeks. A minimum dose of 25 mg. every 2 weeks will be maintained. At the clinician's discretion, the dose may be advanced to 37.5 mg. or 50 mg. In addition, the dose will be raised to 37.5 mg. or 50 mg. if the following conditions remain: (1) Young Mania Rating Scale (YMRS) score > 12; or (2) Evidence of impending relapse; and no dose limiting side effect. If the 25 mg. dose is not tolerated, the dose can be held temporarily; however, attempts will be made to achieve and maintain the dose at 25 mg. (or higher) until the end of the study period.; Treatment was provided in this arm based solely on the choice of the treatment provider and participant. Treatment providers were not part of the study staff and were completely free to make treatment choices except that they were not allowed to select a long-acting injectible.
Other intervention name(s): Risperidone long-acting injectible; Usual care
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar Disorder; Depression, Bipolar; Mania