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

Published online by Cambridge University Press:  24 April 2020

Marlene P. Freeman ,
Maurizio Fava ,
Bryan Dirks ,
Manish K. Jha ,
Richard C. Shelton ,
Michael E. Thase ,
Madhukar H. Trivedi ,
George I. Papakostas ,
Keith Liu  and
Troy Whitworth
...Show all authors
Marlene P. Freeman
Affiliation:
Associate Professor, Psychiatry, Massachusetts General Hospital/Harvard Medical School, Boston, MA
Maurizio Fava
Affiliation:
Professor, Psychiatry, Massachusetts General Hospital/Harvard Medical School, Boston, MA
Bryan Dirks
Affiliation:
Executive Director, Clinical Research, ACADIA Pharmaceuticals Inc., San Diego, CA
Manish K. Jha
Affiliation:
Assistant Professor, Psychiatry & Neuroscience, Icahn School of Medicine at Mt Sinai, New York, NY
Richard C. Shelton
Affiliation:
Professor, Psychiatry, University of Alabama at Birmingham, Birmingham, AL
Michael E. Thase
Affiliation:
Professor, Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA
Madhukar H. Trivedi
Affiliation:
Professor, Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX
George I. Papakostas
Affiliation:
Associate Professor, Psychiatry, Massachusetts General Hospital/Harvard Medical School, Boston, MA
Keith Liu
Affiliation:
Senior Director, Biostatistics, ACADIA Pharmaceuticals Inc., San Diego, CA
Troy Whitworth
Affiliation:
Senior Medical Science Liaison, Medical Affairs, ACADIA Pharmaceuticals Inc., San Diego, CA
Srdjan Stankovic
Affiliation:
President, ACADIA Pharmaceuticals Inc., San Diego, CA
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Abstract:

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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.

Type
Abstracts
Information
CNS Spectrums , Volume 25 , Issue 2 , April 2020 , pp. 313 - 314
Copyright
© Cambridge University Press 2020