Depressive Disorder, Major Clinical Trial
Official title:
A Multinational, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Assess the Efficacy and Safety of Lu AA21004 in Patients With Major Depressive Disorder
The purpose of this study is to assess the efficacy and safety of multiple doses of vortioxetine, once daily (QD), in participants with major depressive disorder.
The drug that was tested in this study is called vortioxetine. Vortioxetine is being tested
to treat depression in adults who have major depressive disorder (MDD). This study looked at
MDD relief in people who took varying doses of vortioxetine.
The study enrolled 600 patients. Participants were randomly assigned (by chance, like
flipping a coin) to one of the four treatment groups—which remained undisclosed to the
patient and study doctor during the study (unless there was an urgent medical need):
- Vortioxetine 5 mg
- Vortioxetine 10 mg
- Vortioxetine 20 mg
- Placebo (dummy inactive pill) - this was a capsule that looked like the study drug but
had no active ingredient.
All participants were asked to take one capsule at the same time each day throughout the
study.
This multi-center trial was conducted in 14 countries in Europe and Asia. The overall time
to participate in this study was up to 13 weeks. Participants made weekly visits to the
clinic during the first 2 weeks of the 8-week treatment period and then every 2 weeks up to
the end of the 8-week treatment period. Participants who completed the 8-week treatment
period entered a 2-week discontinuation period to assess potential discontinuation symptoms
1 and 2 weeks after the end of the 8-week treatment period. A safety follow-up contact
(visit or phone call) was made 4 weeks after completion of the 8-week double-blind treatment
period (2 weeks after the end of the 2-week discontinuation period).
;
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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