Abstract
In a post hoc analysis, the effect of pimavanserin on anxious depression was determined from CLARITY, a randomized, double-blind, placebo-controlled study in patients with major depression and an inadequate response to previous therapy. Patients were randomized in a 3:1 ratio to placebo or pimavanserin 34 mg daily added to ongoing antidepressant therapy. At 5 weeks, placebo nonresponders were rerandomized to placebo or pimavanserin for an additional 5 weeks. Mean change from baseline to week 5 for the Hamilton depression rating scale (HAMD) anxiety/somatization (AS) factor was examined for all patients and those with a score ≥7 at baseline. Least squares (LS) mean [standard error (SE)] difference between placebo and pimavanserin for the AS factor score was-1.5 (0.41) [95% confidence interval (CI)-2.4 to-0.7; P = 0.0003; effect size: 0.634]. Among patients with an AS factor score ≥7 at baseline, LS mean (SE) difference was-2.2 (0.66) (95% CI-3.5 to-0.9; P = 0.0013; effect size: 0.781). Response rates (≥50% reduction in HAMD-17 from baseline) were 22.4 and 55.2% (P = 0.0012) and remission rates (HAMD-17 total score <7) were 5.3 and 24.1% (P = 0.0047), respectively, with placebo and pimavanserin among patients with a baseline AS factor score ≥7. Among patients with anxious major depressive disorder at baseline, adjunctive pimavanserin was associated with a significant improvement.
Original language | English (US) |
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Pages (from-to) | 313-321 |
Number of pages | 9 |
Journal | International Clinical Psychopharmacology |
Volume | 35 |
Issue number | 6 |
DOIs | |
State | Published - Nov 1 2020 |
Keywords
- anxious depression
- controlled study
- pimavanserin
- randomized
ASJC Scopus subject areas
- Psychiatry and Mental health
- Pharmacology (medical)