At a glance
ClinicalIndex Comparison Record- ✓DSM-IV-TR diagnosis of bipolar disorder (I, II, or NOS)
- ✓Age 18 to 70 years
- ✓Y-MRS score >15 at screening/randomization (for manic, mixed, hypomanic, or NOS episodes)
- ✓Clinically appropriate to continue antipsychotic treatment for 15 months
- ✕Active suicidality or dangerousness to others (per investigator)
- ✕Pregnant or lactating women
- ✕Women of reproductive age not using acceptable contraception (abstinence not acceptable) or intending to become pregnant
- ✕Currently receiving clozapine or within 6 weeks prior to randomization
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Random Assignment,Parallel Group, Open Label Comparison of Clinical Outcomes and Resource Utilization Among Bipolar Disorder Patients Receiving Either Long Acting Injectable Risperidone Microspheres (Risperdal Consta® ) or Other Second Generation Oral Antipsychotic Agents: A 15 Month Study
In Brief
A Phase 3 clinical trial evaluating Injectable Risperidone (Consta) or oral antipsychotic for Bipolar I Disorder. Completed, enrolled 50 participants across 4 sites.
Detailed Summary
We recruited 50 consenting adult subjects with DSM-IV TR diagnoses of bipolar disorder who were about to initiate or switch their current antipsychotic agent. Only 48 patients (23 in the risperidone LAI group and 25 in the oral AAP group) contributed data to the assessments. Patients were titrated and cross-tapered during a 3 month titration and stabilization phase. They were followed for an additional 12 months. Clinical outcomes such as study drop out, adverse events, worsening of symptoms, crisis interventions, need for additional medication, hospitalizations etc. were evaluated from months 3 to 15. The numbers of clinical events (pooled) will be used to evaluate if the long acting injectable form of risperidone has an advantage over the oral second generation antipsychotic agents in terms of treatment continuity and clinical stability.
Study Details
Timeline
Interventions
Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder