Summary:
A randomized, double-blind, parallel-group, active-controlled, flexible-dose study evaluating the effect of LU aa21004 vs Escitalopram on sexual functioning in adults with well-treated Major Depressive Disorder experiencing selective serotonin reuptake inhibitor-induced sexual dysfunction.
Qualified Participants Must:
• Between 18 and 55 years of age
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Be undergoing current treatment with SSRI monotherapy (only citalopram, paroxetine, or sertraline allowed) for at least 8 weeks, which was prescribed to treat a major depressive episode (MDE), according to the DSM-IV-TR criteria
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Have depression that is currently stable
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Have a Clinical Global Impression Scale-Severity of Illness Scale (CGI-S) score of ≤3
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Currently be experiencing treatment-emergent sexual dysfunction (TESD: defined as a CSFQ-14 total score ≤41 for women and ≤47 for men), considered to be attributable to the current SSRI monotherapy and is suitable for a switch
Qualified Participants May Receive:
Study medication and all study related visits at no cost. Possible compensation for each completed visit.