Phase 4 N=50 Randomized Single-blind Treatment

Does Risperidone Consta Reduce Relapse and Rehospitalization in Bipolar Disorder?

Bipolar Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00571688 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2017

Primary outcome: Primary: Number of Relapse-related Events Normalized to Unit Time — 5.34; 6.26 Events/month

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Risperdal (risperidone) Consta (Drug); Treatment as usual (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Vanderbilt University
Primary completion: Feb 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Relapse-related Events Normalized to Unit Time	5.34; 6.26	—

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00571688). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.