An Open Comparative Randomized Study of the Effectiveness and Safety of Risperidone and Sodium Valproate for Secondary Prevention of Relapses of Bipolar Disorder I for 24 Months

Abstract

Background: Comparative studies of monotherapy with second-generation antipsychotics (SGA) or mood stabilizers in the prevention therapy of Bipolar Disorder (BD) relapses, including those with psychotic symptoms, have not been conducted. Objective: a comparative study of the clinical features of risperidone (RIS) and sodium valproate (SV) in the prevention of relapses of BD. Patients and methods: 96 patients with BD-I (F31, ICD-10) were included, the duration of the disease was at least 2 years, the presence of at least two affective episodes (including psychotic symptoms). Design — open comparative randomized study. Study duration was 24 months. Patients were sequentially divided into groups of RIS and SV, comparable in the number of patients, clinical and sociodemographic indicators. The effectiveness of therapy was determined by comparing the indicators of the dynamics of the course of the disease for 2 years preceding the start of therapy (control period) and 2 years after the treatment beginning. Results: 14 patients dropped out in the first month after the start of therapy due to adverse events, 82 completed the study. The total duration of episodes decreased by 40-60%, the frequency — by 37.2% — 43.3% (p ≤ 0.05). The proportion of responders in the RIS group was 78.1%, SV — 68.3%. Complete suppression of phase formation was observed in 43.75% in the RIS group, in 10.7% — in the SV group. In the RIS group, the total duration of depressive episodes decreased by 38.3% (NS), manic by 65.2% (p ≤ 0.001), in the SV group — by 31.9% (NS) and by 52.9% (p ≤ 0.05), respectively. As to BD with psychotic symptoms, 85% of respondents were in the RIS group, and 50% were in the SV group. The average number of adverse events per patient in the group of SV was 0.9, RIS — 2.1. Conclusions: SV and RIS are comparable in effectiveness with better tolerance of SV. In patients with psychotic symptoms, the effectiveness of RIS was higher than that of SV.