Does Risperidone Consta Reduce Relapse and Rehospitalization in Bipolar Disorder?
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Risperdal (risperidone) Consta; Treatment as usual
Intervention description: 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.
Intervention MeSH terms: Risperidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Bipolar Disorder; Depression, Bipolar; Mania

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be physically healthy

          -  18-60 years of age

          -  Have a DSM-IV diagnosis of bipolar disorder in any phase, but without current
             psychotic features; with a history of symptomatic relapse on four or more occasions
             over the last year prior to the initiation of study for the treatment of bipolar
             disorder (type I or II, manic, hypomanic, mixed, or depressive type), with at least 1
             in the previous 6 months.

          -  Have a screening Hamilton Rating Scale for Depression-17 item (HAM-D17) score of > 8
             or a Young Mania Rating Scale (YMRS) > 8.

        Exclusion Criteria:

          -  Have any medical condition that would preclude treatment with Risperdal Consta(TM)

          -  Have type 2 diabetes

          -  Have hyperlipidemia (baseline total cholesterol >280)

          -  Have any clinically significant unstable medical condition

          -  Have currently active psychotic symptoms (hallucinations or delusions) or carry a
             diagnosis of another psychotic disorder (schizophrenia, schizoaffective disorder,
             delusional disorder)

          -  Have a documentable history of non-response to Risperidal Consta (TM)

          -  Have a score of 4 on the suicide item (item 3) of the HAM-D scale and/or a
             determination by the investigator of significant suicide risk

          -  Require hospitalization between the screening and baseline visits, or require
             hospitalization immediately following baseline

          -  Have a medical contraindication or hypersensitivity to risperidone or Risperdal Consta
             (TM)