Interim safety analysis n = 37; American Psychiatric Association meeting, Toronto, Canada, May 2006, Society of Biological Psychiatry, Toronto, Canada, May 2006, Collegium Internationale Neuro-psychopharmacologium Conference, Chicago, USA, July 2006.
A 6-month randomized open-label comparison of continuation of oral atypical antipsychotic therapy or switch to long acting injectable risperidone in patients with bipolar disorder
Version of Record online: 7 AUG 2007
Acta Psychiatrica Scandinavica
Volume 116, Issue Supplement s434, pages 50–56, October 2007
How to Cite
Yatham, L. N., Fallu, A. and Binder, C. E. (2007), A 6-month randomized open-label comparison of continuation of oral atypical antipsychotic therapy or switch to long acting injectable risperidone in patients with bipolar disorder. Acta Psychiatrica Scandinavica, 116: 50–56. doi: 10.1111/j.1600-0447.2007.01059.x
- Issue online: 7 AUG 2007
- Version of Record online: 7 AUG 2007
- atypical antipsychotics;
- bipolar disorder;
- long acting injectable risperidone;
Objective: To determine the safety and effectiveness of long-acting injectable risperidone (LAI-ris) add-on in bipolar patients.
Method: A 6-month, open-label, randomized, pilot trial enrolled 49 bipolar out-patients who were taking a mood stabilizer and an atypical antipsychotic (AAP). Patients were maintained on a mood stabilizer and were randomized to continuation of their current AAP or switched to LAI-ris treatment. Safety outcomes included adverse events and changes in vital signs, laboratory tests and extrapyramidal symptoms (EPS). Effectiveness measures included Clinical Global Impression-Severity, scales assessing mania, depression, anxiety, resource utilization, quality of life, subject satisfaction with treatment, and time to intervention.
Results: Twenty-three subjects were randomized to LAI-ris and 26 to oral AAP. There were no significant differences between the groups in adverse events, EPS change scores, weight or other safety measures. LAI-ris group had significant reductions in symptoms as measured by changes in Clinical Global Impression-Severity scores and Young Mania Rating Scale at endpoint relative to baseline and oral AAP group had reductions in Hamilton Anxiety Rating Scale scores relative to baseline but no significant differences were noted between the groups on any of the efficacy measures.
Conclusion: LAI-ris demonstrated similar effectiveness, safety and tolerability compared to oral AAP in this 6 month pilot trial.