Brintellix Effective in Treatment-Emergent Sexual Dysfunction
Takeda and Lundbeck announced the results from a new head-to-head study of Brintellix (vortioxetine) compared to escitalopram (Lexapro; Forest) in patients with well treated major depressive disorder (MDD) experiencing treatment-emergent sexual dysfunction (TESD).
A total of 447 patients with recent major depressive episodes who had responded to SSRI monotherapy but were experiencing TESD were discontinued on their initial treatment and randomized to Brintellix 10mg daily or escitalopram 10mg daily for 8 weeks. The primary endpoint was change from Baseline to Week 8 in the Changes in Sexual Functioning Questionnaire Short-Form (CSFQ-14) total score using mixed-effects model repeated measures approach.
Patients treated with Brintellix (n=169) showed a statistically significant improvement, with a mean treatment difference of 2.2 points (95% CI: 0.48–4.02) in the CSFQ-14 total score after 8 weeks of treatment (P=0.013) vs. escitalopram (n=179). Also, more Brintellix-treated patients were responders (change from baseline in CSFQ-14 total score >3; OR=1.51; P=0.06) compared to the escitalopram-treated patients.
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