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

OBJECTIVE: Although atypical antipsychotics are increasingly being used as monotherapy in acute mania, few Korean studies have investigated on them. This study evaluated the efficacy and tolerability of olanzapine monotherapy in patients with acute mania. METHODS: This multicenter, open-label study evaluated the efficacy of olanzapine to treat mania over 6 weeks. Patients with a DSM-IV diagnosis of bipolar I disorder (manic or mixed episodes) were treated with olanzapine (flexible dosage to a maximum of 30 mg/day). Clinical improvements were rated using the Young Mania Rating Scale (YMRS), Clinical Global Impression-Bipolar Version (CGI-BP), Brief Psychiatric Rating Scale (BPRS), and the Montgomery-Asberg Depression Rating Scale (MADRS). Adverse events were measured using the Simpson-Angus Rating Scale (SARS) and Barnes Akathisia Rating Scale (BARS). The general functioning of patients was assessed using the Global Assessment Scale (GAS). All assessments were carried out at baseline and at days 7, 14, 21, and 42, with the exception of the GAS. RESULTS: The subjects comprised 76 patients (male=38, female=38), with 55 patients (72.4%) completing the study. The mean initial dose of olanzapine was 11.7+/-5.0 mg/day and mean daily doses at days 7, 14, 21, and 42 were 16.6+/-5.2, 17.2+/-5.0, 18.1+/-5.3, and 17.4+/-4.7 mg/day, respectively. At days 7, 14, 21, and 42, YMRS, CGI-BP, MADRS and BPRS scores had significantly improved from baseline. More improvement in MADRS scores was observed among patients with mixed mania than patients with euphoric mania. Changes in BPRS scores from baseline did not differ between patients with psychotic symptoms and those with euphoric mania. At days 21 and 42, 42 (55.3%) and 57 (75.0%) patients had responded (YMRS scores decreased from baseline by more than 50%). Also 27 (35.5%) and 46 (60.5%) patients had achieved remission (YMRS scores < or =12) at the same assessment points. GAS scores at days 21 and 42 indicated that olanzapine monotherapy improved patients' global functioning compared to baseline. SARS and BARS scores did not differ significantly between pre- and post-drug trial. CONCLUSION: The data indicate that olanzapine monotherapy has favorable effects across a broad range of mood symptoms and yields functional improvement in acute manic patients with minimal adverse events. Therefore, olanzapine monotherapy may be a preferred first-line agent to treat patients with acute mania. These results support the findings from previous studies and guidelines.

The Subjective Effect of Quetiapine Monotherapy on Sleep and Daytime Sleepiness in Acute Manic Patient / 대한정신약물학회지

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.