Improvement of sexual functioning during treatment of MDD with adjunctive pimavanserin: A secondary analysis

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

Research output: Contribution to journalArticlepeer-review

6 Scopus citations


Background: Sexual dysfunction is common among patients with major depressive disorder (MDD). In the CLARITY study, the safety and efficacy of adjunctive pimavanserin, an inverse agonist at 5-HT2A receptors, were demonstrated when added to existing treatment for MDD. This analysis provides a detailed assessment of the effects of pimavanserin on sexual function from the CLARITY study. Methods: Patients with a diagnosis of MDD in a depressive episode, inadequate response to ongoing antidepressant therapy, and a Montgomery-Åsberg Depression Rating Scale total score >20 were randomized to pimavanserin 34 mg/day or placebo added to ongoing treatment with an immediate revision of all selective serotonin or serotonin–norepinephrine for 5 weeks (Stage 1), and nonresponders (<50% improvement from baseline in Hamilton Depression Rating Scale [HAMD-17]) were re-randomized for an additional 5 week (Stage 2). Effects of pimavanserin on the Massachusetts General Hospital Sexual Functioning Index (MGH-SFI) and HAMD-17 Item 14 (sexual interest) were examined. Results: Among 203 patients (51 on pimavanserin; 152 on placebo), pimavanserin demonstrated significant improvement from baseline to Week 5 on the MGH-SFI (least square [LS]mean difference −0.634, 95% confidence interval [CI] [−0.964, −0.304]; p =.0002; effect size [ES], Cohen's d:.614). Across Stages 1 and 2, the weighted LSmean difference was −0.468 (95% CI [−0.720, −0.216]; p =.0003) for pimavanserin versus placebo. Mean changes from baseline to Week 5 for MGH-SFI Items 1, 2, 3, and 5 and HAMD Item 14 were significantly (p <.05) greater with pimavanserin versus placebo. Conclusions: Adjunctive pimavanserin improved sexual function in patients with MDD. Adding pimavanserin to ongoing treatment for MDD may be especially useful for patients experiencing sexual dysfunction.

Original languageEnglish (US)
Pages (from-to)485-495
Number of pages11
JournalDepression and anxiety
Issue number5
StatePublished - May 1 2020


  • adjunctive
  • major depressive disorder
  • pimavanserin
  • sexual function

ASJC Scopus subject areas

  • Clinical Psychology
  • Psychiatry and Mental health


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