Treatment Outcome Clinical Trial
Official title:
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
The purpose of this study is to evaluate the effects of Vortioxetine (Lu AA21004), once daily (QD), compared with escitalopram on sexual functioning.
The drug being tested in this study is called Lu AA21004. Lu AA21004 is being tested to
treat people who have major depressive disorder (MDD). This study will look at sexual
function in people who take Lu AA21004.
The study will enroll approximately 440 patients. Participants will be randomly assigned (by
chance, like flipping a coin) to one of the two treatment groups—which will remain
undisclosed to the patient and study doctor during the study (unless there is an urgent
medical need):
- Lu AA21004 10 to 20 mg
- Escitalopram 10 to 20 mg - This is a comparator drug that is also used to treat MDD.
All participants will be asked to take one tablet at the same time each day throughout the
study. All participants will be asked to answer questionnaires at each study visit.
This multi-centre trial will be conducted in the United States and Canada. The overall time
to participate in this study is 14 weeks. Participants will make 7 visits to the clinic, and
will be contacted by telephone 21 days after last dose of study drug for a follow-up
assessment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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