The Effect of Initial Duloxetine Dosing Strategy on Nausea in Korean Patients with Major Depressive Disorder

OBJECTIVE: To assess the relative severity of nausea in patients from Korea with major depressive disorder (MDD) who were treated with duloxetine at low (30 mg) or high (60 mg) doses, with or without food, for the first week of an 8 week treatment. METHODS: Adult patients (n=249), with MDD and a 17-item Hamilton Rating Scale for Depression (HAMD17) score of > or =15, received open-label once daily duloxetine. At Week 0, patients were randomized to 4 groups: 30 mg with food (n=63), 60 mg with food (n=59), 30 mg without food (n=64), and 60 mg without food (n=63). At Week 1, all patients switched to duloxetine 60 mg for 7 weeks. The primary outcome measure was item 112 (nausea) of the Association for Methodology and Documentation in Psychiatry adverse event scale. Effectiveness was assessed by change in HAMD17 total score. RESULTS: Overall, 94.4% (235/249) of patients completed Week 1 and 55.0% (137/249) of patients completed the study. For Week 1, nausea was significantly less severe for patients who received 30 mg compared with 60 mg duloxetine (p=0.003), regardless of food intake. In all groups, nausea severity was highest at Week 1 and declined throughout the study. HAMD17 score was reduced in all groups and the most common adverse event reported was nausea (145/249; 58.2%). CONCLUSION: To minimize nausea, Korean patients with MDD who require duloxetine treatment could be given 30 mg once daily, regardless of food, for the first week followed by 60 mg once daily for the course of therapy.

The frequency and severity of symptoms of major depression in Chinese patients with chronic, medically unexplained, painful physical symptoms who present to a general neurology clinic

This cross-sectional, non-interventional, observational study evaluated depression in patients in China who presented to a general neurologist with chronic, medically unexplained, painful physical symptoms. Of the 402 patients enrolled, 197 patients (49.0%) met the criteria for a current major depressive episode (MDE+ group), as assessed using module A of the Mini International Neuropsychiatric Interview, and 205 patients (51.0%) did not (MDE- group). The mean pain severity visual analogue scale (VAS) score was signifi cantly higher in the MDE+ group than the MDE- group (65.3 vs 55.6 mm; p<0.001). The mean depression severity score, as assessed using the 9-item Patient Health Questionnaire (PHQ-9), was 8.4 units (95% CI: 7.3 to 9.5) higher in the MDE+ group than the MDE- group (mean PHQ-9 total score: 14.8 vs 6.4). Anxiety and perceived health state were signifi cantly worse, on average, in the MDE+ group (mean Hospital Anxiety and Depression Scale anxiety subscale score 10.7 vs 5.9 units; mean EuroQoL-5 Dimensions VAS score 56.4 vs 67.7 mm; each p<0.001). Only 14.2% of patients had received treatment for depression during the past 3 months. These results suggest depression was common and may have been under-treated in this group of Chinese patients with chronic, medically unexplained painful physical symptoms.

A Randomized, Open-Label Assessment of Response to Various Doses of Atomoxetine in Korean Pediatric Outpatients with Attention-Deficit/Hyperactivity Disorder

OBJECTIVE: This multicenter, randomized, open-label, parallel trial aimed to provide a detailed dose-response profile for atomoxetine in Korean pediatric outpatients with attention-deficit/hyperactivity disorder (ADHD). METHODS: Male and female outpatients aged 6-18 years with ADHD meeting symptom severity criteria of 1.5 standard deviations above age and gender norms on the ADHD Rating Scale-IV-Parent: Investigator-Administered and Scored (ADHDRS-IV-Parent: Inv), and a Clinical Global Impression-ADHD-Severity score > or =4 were randomized to atomoxetine (mg/kg/day) 0.2 fixed, 0.5 fixed or 0.5 (7 days), 0.8 (7 days) then 1.2 for 28 days. The primary efficacy measure was change in ADHDRS-IV-Parent: Inv total score after 6 weeks of atomoxetine treatment. RESULTS: Of 153 randomized patients, 83.7% were male and mean age was 9.8 (SD+/-2.4) years. The completion rate was 86.9%. A graded dose response was apparent with mean change in ADHDRS-IV-Parent: Inv total scores of -9.6, -12.3 and -14.5 with atomoxetine 0.2, 0.5 and 1.2 mg/kg/day, respectively (p=0.024 - F-test). Moreover, a greater reduction in ADHD symptoms, as assessed by mean change from baseline to endpoint CGI-S and mean CGI-ADHD-Improvement at endpoint, was also observed with increasing atomoxetine dose. More patients receiving atomoxetine 1.2 mg/kg/day reported > or =1 treatment-emergent adverse event/s (58.3%) compared with 0.5 (40.7%; p=0.11) or 0.2 mg/kg/day (29.4%; p=0.005). These were generally mild to moderate. CONCLUSION: Atomoxetine was found to be safe and well tolerated at all doses administered in Korean pediatric ADHD patients, and 1.2 mg/kg/day was an efficacious dose in this population.