Conditions: Generalized Anxiety Disorder
Keywords: Generalized Anxiety Disorder Mood Disorder Affective Disorder Anxiety Disorder Drug Therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 457
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of 2.5 mg and 10 mg vortioxetine, once daily (QD), in adults with generalized anxiety disorder.

Detailed description:
Participants in this study will be randomly assigned to receive either 2.5 mg or 10 mg of vortioxetine or a placebo once daily for an eight week treatment period.

Participants will be seen weekly during the first 2 weeks of treatment, and then every 2 weeks up to the end of the 8-week treatment period. Total commitment time is up to 12 weeks.

Arms:
arm 1: Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks. arm 2: Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks. arm 3: Vortioxetine 10 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: