Phase 4
Completed N=50
Does Risperidone Consta Reduce Relapse and Rehospitalization in Bipolar Disorder?
Source: ClinicalTrials.gov NCT00571688 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Number of Relapse-related Events Normalized to Unit Time — 5.34; 6.26 Events/month
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Relapse-related Events Normalized to Unit Time |
5.34; 6.26 | — |
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)
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. Informational only — not medical advice.