کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
6230013 1608124 2016 8 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Brexpiprazole as adjunctive treatment of major depressive disorder with anxious distress: Results from a post-hoc analysis of two randomised controlled trials
ترجمه فارسی عنوان
برکسپیپرایزول به عنوان درمان اضافی اختلال افسردگی اساسی با اضطراب مضطرب: نتایج یک تحلیل بعد از دو کارآزمایی تصادفی کنترل شده
کلمات کلیدی
درمان کمکی برکسپیرازول، اختلال افسردگی عمده، اضطراب اضطراب،
موضوعات مرتبط
علوم پزشکی و سلامت پزشکی و دندانپزشکی روانپزشکی و بهداشت روانی
چکیده انگلیسی


- Brexpiprazole is an adjunctive therapy for treatment of MDD.
- Anxiety symptoms are prevalent in MDD and associated with greater illness severity.
- We investigated brexpiprazole in patients with MDD and anxious distress.
- Brexpiprazole was efficacious in patients with MDD with/without anxious distress.

BackgroundAnxiety symptoms are prevalent in major depressive disorder (MDD) and are associated with greater illness severity, suicidality, impaired functioning and poor response to antidepressant treatment (ADT). The efficacy and safety of brexpiprazole - a serotonin-dopamine activity modulator - as adjunctive treatment in patients with MDD was recently evaluated in two phase 3 studies. We here present a post-hoc analysis of the efficacy of adjunctive brexpiprazole in patients with MDD and symptoms of anxious distress, defined using proxies for DSM-5 criteria.MethodsEligible patients were randomized to 2 mg brexpiprazole+ADT or placebo+ADT (NCT01360645); or 1 mg brexpiprazole+ADT, 3 mg brexpiprazole+ADT, or placebo+ADT (NCT01360632), respectively. Patients were defined as having anxious distress if they had ≥2 of the symptoms tension (MADRS item 3 score ≥3), restlessness (IDS item 24 score ≥2), concentration (MADRS item 6 score ≥3), or apprehension (HAM-D item 10 score ≥3). Primary efficacy endpoint was change in MADRS total score from baseline to Week 6.Results55% of the patients had anxious distress at baseline. Adjunctive brexpiprazole showed greater improvement than adjunctive placebo on the primary efficacy endpoint in both patients with (least square mean difference to placebo+ADT: 2 mg+ADT: −2.95, p=0.0023; 3 mg+ADT: −2.81, p=0.0027); and without anxious distress (1 mg+ADT: −2.37, p=0.0093; 3 mg+ADT: −2.23, p=0.0131). Brexpiprazole in patients with anxious distress was not associated with an increased incidence of activating adverse events (e.g., akathisia).ConclusionsAdjunctive brexpiprazole 2-3 mg may be efficacious in reducing depressive symptoms and is well tolerated, in patients with MDD and anxious distress.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Affective Disorders - Volume 201, 1 September 2016, Pages 116-123
نویسندگان
, , , ,