Does Risperidone Consta Reduce Relapse and Rehospitalization in Bipolar Disorder?
Information source: Vanderbilt University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder
Intervention: Risperdal (risperidone) Consta (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Vanderbilt University Official(s) and/or principal investigator(s): Richard C Shelton, M.D., Principal Investigator, Affiliation: Vanderbilt University
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.
Clinical Details
Official title: Does Risperidone Consta Reduce Relapse and Rehospitalization in Bipolar Disorder?
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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.
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
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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)
Locations and Contacts
Mental Health Cooperative, Inc., Nashville, Tennessee 37228, United States
Additional Information
Starting date: November 2007
Last updated: June 1, 2015
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