Acute phase results from STORM, a multicountry observational study of bipolar disorder treatment and outcomes.

OBJECTIVES: This prospective observational study examined the outcomes associated with the treatment of bipolar mania in clinical practice settings in a diverse range of countries: Bosnia, Slovenia, Slovakia, Egypt, Saudi Arabia and Turkey. Particular emphasis was placed on investigating outcomes associated with treatment regimens including and excluding the atypical antipsychotic olanzapine.

SUBJECTS AND METHODS: In- and outpatients initiating or changing oral medication for the treatment of bipolar mania were grouped into two treatment cohorts: (1) olanzapine (N=569), and (2) non-olanzapine (N=325). Clinical outcome measures included change in Clinical Global Impressions-Bipolar Version Severity of Illness scale (CGI-BP), Young Mania Rating Scale (YMRS) and Hamilton Depression Rating scale- 5 item (HAMD-5) scores, and response and remission rates. Outcomes were analysed by conventional linear or logistic regression, adjusted for potential confounders, using last observation carried forward (LOCF) at endpoint, and a marginal structural model (MSM) approach to account for treatment switching. Results from the 12-week acute phase are presented.

RESULTS: Clinical improvements were observed in both cohorts. While no marked differences were apparent between the groups in adjusted mean baseline to LOCF endpoint change, longitudinal analysis of these variables using MSM averaged over all visits indicated greater improvements in the olanzapine versus non-olanzapine cohort in CGI-BP Overall (-0.26, p<0.001), CGI-BP Mania (-0.19, p<0.001), CGI-BP Depression (-0.10, p=0.003), CGI Psychosis (-0.14, p=0.001), YMRS (-1.70, p<0.001), and HAMD-5 (-0.40, p<0.001) scores.

CONCLUSIONS: Inclusion of olanzapine after initiating or switching treatment for bipolar mania appeared to be beneficial during treatment in terms of symptom improvement.