drugset / Trial / NCT00177164

Risperdal Consta for Bipolar Disorder

NCT00177164

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2003-11
Primary completion
2008-03
Completion
2009-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aripiprazole Other / unclassified 15 mg
Comparator Aripiprazole Other / unclassified 30 mg
Comparator Olanzapine Small molecule 15 mg
Comparator Olanzapine Small molecule 25 mg
Comparator Quetiapine Small molecule 300 mg
Comparator Quetiapine Small molecule 700 mg
Comparator Risperidone Other / unclassified 25 mg
Comparator Risperidone Other / unclassified 37.5 mg
Comparator Risperidone Other / unclassified 50 mg
Comparator Ziprasidone Small molecule 160 mg

Indications