A Double-Blind, Placebo-Controlled Study of Quetiapine and Lithium Monotherapy in Adults in the Acute Phase of Bipolar Depression (EMBOLDEN I)
JOURNAL OF CLINICAL PSYCHIATRY
Authors: Young, Allan H.; McElroy, Susan L.; Bauer, Michael; Philips, Nabil; Chang, William; Olausson, Bengt; Paulsson, Bjoern; Brecher, Martin
Abstract
Objective: The aim of this study was to compare the efficacy and tolerability of quetiapine and lithium monotherapy with that of placebo for a major depressive episode in bipolar disorder. Method: 802 patients with DSM-IV-defined bipolar disorder (499 bipolar 1, 303 bipolar 11) were randomly allocated to quetiapine 300 mg/d (n = 265), quetiapine 600 mg/d (n = 268), lithium 600 to 1800 mg/d (n = 136), or placebo (n = 133) for 8 weeks. Primary endpoint was the change in Montgomery-Asberg Depression Rating Scale (MADRS) total score. The study was conducted from August 2005 to May 2007. Results: Mean MADRS total score change from baseline at week 8 was -15.4 for quetiapine 300 mg/d, -16.1 for quetiapine 600 mg/d, -13.6 for lithium, and -11.8 for placebo (P<.001 for both quetiapine doses, P=.123 for lithium, vs placebo). Quetiapine 600 mg/d was significantly more effective than lithium in improving MADRS total score at week 8 (P=.013). Quetiapine-treated (both doses), but not lithium-treated, patients showed significant improvements (P<.05) in MADRS response and remission rates, Hamilton Depression Rating Scale (HDRS), Clinical Global Impressions-Bipolar-Severity of Illness and -Change, and Hamilton Anxiety Rating Scale (HARS) scores at week 8 versus placebo. Both quetiapine doses were more effective than lithium at week 8 on the HDRS and HARS. The most common adverse events were somnolence, dry mouth, and dizziness with quetiapine (both doses) and nausea with lithium. Conclusions: Quetiapine (300 or 600 mg/d) was more effective than placebo for the treatment of episodes of acute depression in bipolar disorder. Lithium did not significantly differ from placebo on the main measures of efficacy. Both treatments were generally well tolerated.
Symptom Dimensions of Anxiety Following Myocardial Infarction: Associations With Depressive Symptoms and Prognosis
HEALTH PSYCHOLOGY
Authors: Roest, Annelieke M.; Heideveld, Anne; Martens, Elisabeth J.; de Jonge, Peter; Denollet, Johan
Abstract
Objective: Differential associations of symptom dimensions with prognosis in myocardial infarction (MI) patients have been shown for depression, but no studies have focused on anxiety dimensions. The aim of this study was to assess the association between somatic and psychological symptoms of anxiety following acute MI with adverse prognosis and to assess the overlap between anxiety and depression dimensions. Method: Patients (n = 418) were assessed on demographic and clinical variables. The Hamilton Anxiety and Depression Rating Scales were used to measure anxiety and depression 2 months post-MI. Mean follow-up period was 3.8 years and the endpoint consisted of all-cause mortality and recurrent MI. Results: After adjustment for demographic and clinical variables, somatic anxiety was significantly associated with recurrent MI and mortality (HR: 1.32; 95% CI [1.03, 1.69]; p = .03), and a trend was shown for an association between psychological anxiety and outcome (HR: 1.29; 95% CI [0.99, 1.67]; p = .06). The total anxiety score of the HARS was the strongest predictor of recurrent MI and mortality (HR: 1.38; 95% CI [1.07, 1.78]; p = .02). The HARS and the HDRS were highly correlated (r = .86; p = .01). Dimensions consisting of psychological distress (HR: 1.29; 95% CI [1.02, 1.63]; p = .03) and cardiopulmonary/autonomic symptoms (HR: 1.36; 95% CI [1.06, 1.75]; p = .02) also predicted outcome in adjusted analyses. Conclusions: Anxiety was associated with adverse prognosis in MI patients with significant associations for somatic anxiety and total anxiety. When combining anxiety and depression items, psychological distress and cardiopulmonary/autonomic symptoms predicted recurrent MI and mortality. Future research might better focus on dimensions of anxiety and depression simultaneously in MI patients.