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Title: Interim Results Show Long-Acting Injectable Risperidone Comparable in Efficacy and Safety as Oral Antipsychotic in Bipolar Disorder: Presented at CPA

"Interim Results Show Long-Acting Injectable Risperidone Comparable in Efficacy and Safety as Oral Antipsychotic in Bipolar Disorder: Presented at CPA"

By Steve Pridgeon VANCOUVER, CANADA -- November 14, 2005 -- Compliance with oral treatment can be problematic in patients with bipolar disorder, but an investigational long-acting injectable drug might provide benefits in this area. Use of a long-acting injectable antipsychotic medication has the potential to provide reliable drug delivery, reduce pharmacokinetic variability and improve patient compliance, said Lakshmi Yatham MD, Professor of Psychiatry and Director, Mood Disorders Clinical Research Unit, University of British Columbia, Vancouver, British Columbia, Canada. Dr. Yatham presented interim results from a prospective, open-label, pilot safety and effectiveness trial in a presentation here on November 4[^th at the 55^th annual conference of the Canadian Psychiatric Association (CPA).

He speculated that the injectable formulation might help bypass first-pass metabolism, which could lead to greater efficacy and fewer side effects.

Dr. Yatham and colleagues conducted a 6.5-month evaluation of a long-acting injectable formulation risperidone in 40 patients with bipolar I/II disorder. The study included a control arm of oral antipsychotic treatment.

Patients were randomized to either continue on their current oral antipsychotic or switch to injectable risperidone administered every 2 weeks. All subjects remained on their original treatment of lithium plus valproate or lamotrigine and one antidepressant.

Safety results were monitored using incidence of side effects, change in weight, Barnes Akathisia Rating scale (BARS), Abnormal Involuntary Movements Scale (AIMS) and Simpson Angus Rating Scale (SAS).

Dr. Yatham presented preliminary results on 15 patients. Side effects were comparable in both treatment groups, although nausea and vomiting were lower in the injectable risperidone arm. There was no evidence of increased liability to movement disorders in the group on injectable risperidone.

Movement disorder scores remained low in both groups throughout the period evaluated. The researchers noted some improvement in movement scores at the last visit.

Weight loss was slightly higher in subjects on injectable risperidone, but was less than 1 kg at the last visit.

Clinical Global Impression-Severity Scale (CGI-S) scores indicated that both treatments maintained symptom control.

The investigators said that analysis of the final results in the 40-patient dataset will help to determine if the trends noted so far will be maintained.

[Presentation title: New Treatment Paradigm in Bipolar Disorder: A Randomized Trial of Long Acting Injectable Risperidone vs Oral Atypical Antipsychotics. Abstract P-07]

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