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Does Risperidone Consta Reduce Relapse and Rehospitalization in Bipolar Disorder?

This study has been completed.
Sponsor:
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00571688
First received: December 11, 2007
Last updated: August 2, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Drug: Risperdal (risperidone) Consta
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does Risperidone Consta Reduce Relapse and Rehospitalization in Bipolar Disorder?

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: November 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Risperdal Consta
Risperdal Consta injection in conjunction with existing treatment
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571688

Locations
United States, Tennessee
Mental Health Cooperative, Inc.
Nashville, Tennessee, United States, 37228
Sponsors and Collaborators
Vanderbilt University
Ortho-McNeil Janssen Scientific Affairs, LLC
Investigators
Principal Investigator: Richard C Shelton, M.D. Vanderbilt University
  More Information

No publications provided

Responsible Party: Richard C. Shelton, M.D. Principal Investigator, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00571688     History of Changes
Other Study ID Numbers: RIS-BIP-4005, RIS-BIP-4005
Study First Received: December 11, 2007
Last Updated: August 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Bipolar Disorder
Depression, Bipolar
Mania

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes
Risperidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2014