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180 Improvement of Sexual Function Observed During Treatment of Major Depressive Disorder with Adjunctive Pimavanserin

  • Marlene P. Freeman (a1), Maurizio Fava (a2), Bryan Dirks (a3), Manish K. Jha (a4), Richard C. Shelton (a5), Michael E. Thase (a6), Madhukar H. Trivedi (a7), George I. Papakostas (a8), Keith Liu (a9), Troy Whitworth (a10) and Srdjan Stankovic (a11)...

Abstract:

Study Objectives:

Sexual dysfunction occurs in 40%-60% of patients with major depressive disorder (MDD), due to either the illness itself and/or the effects of antidepressant treatment. The phase-2 CLARITY trial recently demonstrated the efficacy of adjunctive pimavanserin (PIM) for MDD when added to ongoing selective serotonin or serotonin–norepinephrine reuptake inhibitor (SSRI/SNRI) treatment. No new safety observations were reported in this study. This post-hoc analysis examines the potential impact of PIM treatment on sexual function.

Method:

Study methodology has been presented previously (APA 2019). Adult male and female patients with moderate-to-severe MDD were randomized to PIM 34 mg/day (n=51) or placebo (PBO, n=152) added to ongoing SSRI/SNRI treatment. Massachusetts General Hospital–Sexual Functioning Inventory (MGH-SFI) and Hamilton Depression Rating Scale, 17-item version (HAMD-17) item 14 (sexual interest) scores were examined by analysis of covariance.

Results:

Adjunctive PIM resulted in significantly greater 5-week reduction (improvement) relative to SSRI/SNRI treatment plus placebo on mean MGH-SFI scores (difference –0.634, SE 0.167; P<0.001; effect size [ES], Cohen’s d 0.614). Similarly, PIM resulted in greater improvement compared with placebo on individual MGH-SFI items that applied to both males and females: Interest in Sex (P=0.006; ES=0.483), Ability to Get Sexually Aroused/Excited (P=0.001; ES=0.560), Ability to Achieve Orgasm (P<0.001; ES=0.609), Overall Sexual Satisfaction (P=0.003; ES=0.524). HAMD-17 item 14 scores were also significantly more reduced (improved) with PIM (P<0.001; ES=0.574).

Conclusions:

These results underscore the potential of adjunctive PIM for improving sexual function in patients with MDD and inadequate response to SSRIs/SNRIs. Potential benefits should be confirmed in further studies.

Funding Acknowledgements:

ACADIA Pharmaceuticals Inc.

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180 Improvement of Sexual Function Observed During Treatment of Major Depressive Disorder with Adjunctive Pimavanserin

  • Marlene P. Freeman (a1), Maurizio Fava (a2), Bryan Dirks (a3), Manish K. Jha (a4), Richard C. Shelton (a5), Michael E. Thase (a6), Madhukar H. Trivedi (a7), George I. Papakostas (a8), Keith Liu (a9), Troy Whitworth (a10) and Srdjan Stankovic (a11)...

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