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Sexual functioning in patients with major depressive disorder in randomized placebo-controlled studies of extended release quetiapine fumarate

Published online by Cambridge University Press:  25 September 2013

Anita H. Clayton ,
Julie C. Locklear ,
Henrik Svedsäter  and
Roger S. McIntyre
Anita H. Clayton*
Affiliation:
Department of Psychiatry and Neurobehavioral Sciences, University of Virginia, Charlottesville, Virginia, USA
Julie C. Locklear
Affiliation:
Formerly AstraZeneca Pharmaceuticals, Wilmington, Delaware, USA
Henrik Svedsäter
Affiliation:
Formerly AstraZeneca R&D, Mölndal, Sweden
Roger S. McIntyre
Affiliation:
Department of Psychiatry, University Health Network, University of Toronto, Toronto, Ontario, Canada
*
*Address for correspondence: Anita H. Clayton, MD, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia, 2955 Ivy Road, Northridge Suite 210, Charlottesville, VA 22903, USA. Email [email protected]
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Abstract

Objective

We evaluated sexual functioning from 6 acute, randomized, placebo-controlled studies (6–10 weeks) of once-daily extended release quetiapine fumarate (quetiapine XR) 50, 150, or 300 mg/day as monotherapy (Studies 1–4) or adjunct therapy (Studies 6–7) in major depressive disorder (MDD).

Methods

We present a pre-planned, non-inferiority analysis of quetiapine XR monotherapy versus placebo using Changes in Sexual Functioning Questionnaire (CSFQ) total score change (Studies 1–4). Post hoc analyses evaluated CSFQ total and domain scores for fixed-dose monotherapy (Studies 1–2), modified fixed-dose (Studies 3–4), and adjunct therapy studies (Studies 6–7). CSFQ data for active comparators (duloxetine [Study 2], escitalopram [Study 4]) are reported.

Results

Quetiapine XR monotherapy was non-inferior to placebo for sexual functioning (least squares mean [LSM] difference in CSFQ score change versus placebo, 0.16 [95% confidence interval: −0.59, 0.92]); LSM change in CSFQ score: 1.90, quetiapine XR (all doses) and 1.73, placebo. LSM differences versus placebo (95% confidence interval): 0.18 (−1.40, 1.75), duloxetine (Study 2); 0.16 (−1.77, 2.10), escitalopram (Study 4). LSM differences with adjunct quetiapine XR 150 mg/day (0.52; p = 0.338) or 300 mg/day (0.22; p = 0.679) were comparable with placebo plus antidepressants. Post hoc all-patient and gender-specific analyses were comparable for CSFQ total scores versus placebo with quetiapine XR 50, 150, or 300 mg/day, duloxetine, and escitalopram.

Discussion

Lack of negative effects on sexual functioning in patients with MDD may improve treatment acceptability.

Conclusion

Quetiapine XR (monotherapy or adjunct therapy) had an impact on sexual function that was comparable with placebo.

Keywords

Adjunct therapyextended release quetiapine fumaratemajor depressive disordermonotherapynon-inferiority analysissexual dysfunction
Type
Original Research
Information
CNS Spectrums , Volume 19 , Issue 2 , April 2014 , pp. 182 - 196
Copyright
Copyright © Cambridge University Press 2013 

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