Conditions: Generalized Anxiety Disorder
Keywords: Generalized Anxiety Disorder Mood Disorder Affective Disorder Anxiety Disorder Drug Therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 304
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily (QD), in treating Generalized Anxiety Disorder.

Detailed description:
The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested to treat anxiety in adults who have general anxiety disorder (GAD). This study looked at GAD relief in people who took vortioxetine.

The study enrolled 304 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):

* Vortioxetine 5 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 the United States. The overall time to participate in this study was up to 13 weeks. Participants made 7 visits to the clinic, and were contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.

Arms:
arm 1: Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks. arm 2: Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.

Interventions: intervention 1: Vortioxetine intervention 2: Placebo
Intervention descriptions: intervention 1: Encapsulated vortioxetine immediate-release tablets intervention 2: Vortioxetine placebo-matching capsules

Protocol document: