Official Title: “Does Risperidone Consta Reduce Relapse and Rehospitalization in Bipolar Disorder?”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Study Primary Completion Date: February 2009

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(s) in this Clinical Trial

• Drug: Risperdal (risperidone) Consta
  • Risperdal Consta (TM) will be administered every 2 weeks by deep intramuscular 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) 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Risperdal Consta
  • Risperdal Consta injection in conjunction with existing treatment
• No Intervention: Treatment As Usual
  • Clinician and patient decide upon treatment, as in a non-research clinical setting. The only treatment exclusion is any form of risperidone.

Primary Measures

• The principal outcome will be number of events normalized to unit time; this will be calculated by dividing the number of relapse related events by the number of months of participation.
  • Time Frame: 1 year
    Safety Issue?: No

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 HAM-D17 score of > 8 or a 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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Vanderbilt University

Overall Clinical Trial Officials and Contacts

Richard C Shelton, M.D. Principal Investigator Vanderbilt University  

Overall Contact: Tynya D Patton, M.A. 615-743-1560 tynya.patton@vanderbilt.edu

Information obtained from ClinicalTrials.gov on January 08, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00571688

Study ID Number: RIS-BIP-4005

ClinicalTrials.gov Identifier: NCT00571688

Health Authority: United States: Institutional Review Board