Overview

Risperdal Consta for Bipolar Disorder

Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
University of Pittsburgh
Collaborator:
Janssen Pharmaceuticals
Treatments:
Antipsychotic Agents
Aripiprazole
Olanzapine
Quetiapine Fumarate
Risperidone
Ziprasidone