Summary:
A randomized,aDouble-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:
• Be between 18 and 55 years of age
•
Currently be undergoing 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
•
Have depression that is currently stable
•
Have a Clinical Global Impression Scale-Severity of Illness Scale (CGI-S) score of ≤3
•
The participant is currently 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. In addition, possible compensation for each completed visit.