ABSTRACT
OBJECTIVE: It is well known that treatment with quetiapine can easily cause somnolence and daytime sleepiness in patients with bipolar disorder. Such sedation may be the discomfort to the drug in terms of patient's perspectives and results in drug noncompliance. This study was aimed to investigate the effect of 6-week quetiapine monotherapy on subjective aspects of sleep in patients with acute bipolar disorder. METHODS: In a Korean multi-center, open-label, 6-week study, patients with a DSM-IV diagnosis of bipolar I disorder (manic or mixed episodes) were included to treatment with quetiapine. The dose of quetiapine initially started at 200 mg/day and rapid titrated up to 800 mg/day within day 7 according to the clinical judgements. Clinical improvement was evaluated using Young Mania Rating Scale (YMRS) and Clinical Global Impression-Bipolar version (CGI-BP). Extrapyramidal side effects were measured by Simpson-Angus Rating Scale (SARS) and Barnes Akathisia Rating Scale (BARS). The overall subjectively reported adverse events were gathered during the study period. Subjective sleep questionnaire modified from Leeds Sleep Evaluation Questionnaire (LSEQ) was used to assess the subjective measures of sleep, which included the aspects covering the ease of getting to sleep (GTS), quality of sleep (QOS) and hangover behavior next day (HOV). All assessments were done at baseline and days 7, 14, 21 and 42 after treatment with quetiapine. Analyses were focused to compare the differences between pre-drug baseline and post-treatment with quetiapine. RESULTS: Total 78 (male=30, female=48) patients were included and most of them were inpatients (N=59, 74.7%). Fifty-nine (75.9%) patients were completed the study. Mean changes of YMRS from baseline were significant at days 7, 14, 21 and 42. There were no significant differences from baseline in SARS and BARS at any assessment points. The common subjectively reported adverse events were somnolence, dizziness and dry mouth. While mean changes of 5 items measuring nighttime sleep (GTS and QOS) from baseline were significantly improved at days 7, 14, 21 and 42, those of HOV were not differed between baseline and post-treatment assessments. CONCLUSION: Data showed that quetiapine monotherapy had favorable effect on acute manic symptoms and well tolerated. Also this result suggests that quetiapine monotherapy may improve the self-perceived quality of sleep without any daytime impairment following sleep in acute manic patients.