The Efficacy and Safety of Quetiapine Monotherapy in Patients with Acute Mania: A Multi-Center, Open-Label Trial / 대한정신약물학회지

ABSTRACT

OBJECTIVE: Recently, the atypical antipsychotics such as quetiapine, olanzapine, risperidone, aripiprazole and ziprasidone are increasingly used in the management of acute manic patients as the monotherapy. But there are only a few reports on the use of these drugs in the treatment of bipolar disorder in Korea. The aim of this study was to evaluate the efficacy and tolerability of quetiapine monotherapy in patients with acute mania. METHOD: This study is multi-center, open-label, 6-week evaluation of the efficacy of quetiapine in bipolar mania. In this study, patients with a DSM-IV diagnosis of bipolar I disorder (manic or mixed episodes) were included to treatment with quetiapine (flexibly dosed up to 800 mg/day). Clinical improvements were rated by Young Mania Rating Scale (YMRS), Clinical Global Impression-Bipolar Version (CGI-BP), Brief Psychiatric Rating Scale (BPRS) and Montgomery-Asberg Depression Rating Scale (MADRS). Adverse events were measured using Simpson-Angus Rating Scale (SARS) and Barnes Akathisia Rating Scale (BARS), and subjective reports of patients were evaluated. Global Assessment Scale (GAS) was used to evaluate the general functioning of patients. All assessments were done at baseline and at days 7, 14, 21, and 42 except GAS (at days 21 and 42). Analyses were focused on change from baseline to day 42. RESULTS: Total 78 (male=30, female=48) patients were included and 59 patients (75.6%) completed the study. The mean initial dose of quetiapine was 268.0+/-223.2 mg/day and mean daily dose at day 42 was 585.3+/-244.5 mg/day. YMRS and CGI-BP were significantly improved at day 7, 14, 21, and 42 as compared to baseline. Mean scores of BPRS and MADRS were also significantly decreased at the each assessment points. Fifty-two patients (66.7%) showed response (more than 50% of decrease in YMRS score from baseline) and 35 patients (44.6%) reached remission (YMRS score < or =12) at day 21. GAS showed the improvements of patient's global functioning at days 21 and 42 of quetiapine monotherapy compared to baseline. There was no significant difference between baseline and any assessment points on SARS and BARS scores. CONCLUSIONS: The data showed that quetiapine monotherapy has favorable effects across a broad range of mood symptoms with minimal adverse events in addition to functional improvement in acute manic patients. This result suggests that quetiapine may be preferred for patients with acute mania as one of the first-line agents.