Extended-release quetiapine fumarate (quetiapine XR) monotherapy and quetiapine XR or lithium as add-on to antidepressants in patients with treatment-resistant major depressive disorder

Background

Patients with treatment-resistant major depressive disorder (MDD) remain a common clinical challenge.

Methods

This 6-week, randomised, open-label, rater-blinded trial evaluated once-daily extended-release quetiapine fumarate (quetiapine XR; 300 mg/day) as add-on to ongoing antidepressant and quetiapine XR monotherapy (300 mg/day) compared with add-on lithium (0.6–1.2 mmol/L) in patients with treatment-resistant MDD. Primary efficacy measure: change in Montgomery Åsberg Depression Rating Scale (MADRS) total score from randomisation to week 6 with a pre-specified non-inferiority limit of 3 points on the MADRS.

Results

At week 6, both add-on quetiapine XR (n=231) and quetiapine XR monotherapy (n=228) were non-inferior to add-on lithium (n=229); least squares means (LSM) differences (97.5% CI) in MADRS total score changes were −2.32 (−4.6, −0.05) and −0.97 (−3.24, 1.31), respectively. LSM MADRS total score change was numerically greater at day 4 for both quetiapine XR groups (add-on and monotherapy; p<0.01) compared with add-on lithium. At week 6, the differences between groups for the secondary endpoints of MADRS response (≥50% reduction in total score), MADRS remission (total score ≤10, add-on quetiapine XR only) and Clinical Global Impressions (‘much’/‘very much’ improved) were numerically similar. Overall tolerability was consistent with the known profiles of both treatments.

Limitations

Limitations included the open-label study design (although MADRS and laboratory measurements were performed by treatment-blinded raters) and relatively short study duration with no assessments in the continuation phase.

Conclusions

Add-on quetiapine XR (300 mg/day) and quetiapine XR monotherapy (300 mg/day) are non-inferior to add-on lithium in the management of patients with treatment-resistant MDD.     

人际心理治疗与认知行为治疗对广泛性焦虑障碍治疗效果的对照研究

目的:探讨人际心理治疗与认知行为治疗对广泛性焦虑障碍的疗效。方法:将90例广泛性焦虑障碍患者随机分为人际心理治疗组(IPT)和认知行为治疗组(CBT)各45例,疗程为12周,分别于治疗前后采用汉密尔顿焦虑量表(HAMA)和汉密尔顿抑郁量表(HAMD)评定临床疗效。结果:治疗后,两组的HAMA、HAMD评分都明显低于治疗前(如HAMAt=9.97,11.41;P均0.01);治疗后CBT组的睡眠障碍因子分差值低于IPT组(t=2.34,P0.05),两组间其余因子分差值无显著性差异(如HAMAt=-0.51,P0.05)。结论:人际心理治疗与认知行为治疗对广泛性焦虑障碍均有疗效,认知行为治疗在改善睡眠障碍方面要优于人际心理治疗。     

The effect of preseasonal immunotherapy on the production of histamine-releasing factor (HRF) by mononuclear cells from patients with seasonal asthma: results of a double-blind, placebo-controlled, randomized study

The effect of immunotherapy on the production of histamine-releasing factor (HRF) by mononuclear cells (MNC) from patients with seasonal asthma was investigated in a double-blind, placebo-controlled, randomized study. Twenty-four patients with asthma were randomly divided into a placebo-treated group and a grass pollen-treated group. In vitro production of HRF by MNCs and the provocative concentration of histamine that causes 20% fall in FEV1 were measured before and after immunotherapy, and symptoms were monitored during the pollen season. MNCs from the patients were either cultured alone, spontaneous HRF production (spHRF), or in the presence of grass allergens (grass-stimulated HRF production), and the supernatants were assayed for HRF activity with basophils from a single donor after the study. We found that MNCs from patients with seasonal asthma to grass pollen spontaneously produce substantial amounts of HRF. The group of patients treated with placebo developed typical symptoms in the pollen season and also an increase in HRF production. In contrast, patients treated with grass pollen demonstrated reduced symptoms and no increase in spHRF production. A high degree of correlation between spHRF productions and symptom scores in both treated groups was noted. After 2 years of immunotherapy, allergen-stimulated HRF production decreased significantly, whereas spHRF production decreased significantly only in the patients who were clinically benefitted. The change in the provocative concentration of histamine that causes 20% fall in FEV1 during the pollen season highly correlated with the change in HRF production. The results of this study suggest that HRF might be involved in the pathogenesis of atopic asthma.