Effect of pimavanserin on anxious depression in patients with major depression and an inadequate response to previous therapy: Secondary analysis of the clarity study

George I. Papakostas, Maurizio Fava, Marlene P. Freeman, Richard C. Shelton, Michael E. Thase, Manish K. Jha, Madhukar H. Trivedi, Bryan Dirks, Keith Liu, Srdjan Stankovic

Research output: Contribution to journalArticlepeer-review

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 languageEnglish (US)
Pages (from-to)313-321
Number of pages9
JournalInternational Clinical Psychopharmacology
DOIs
StateAccepted/In press - 2020

Keywords

  • anxious depression
  • controlled study
  • pimavanserin
  • randomized

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Pharmacology (medical)

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