Conditions: Generalized Anxiety Disorder
Keywords: Generalized Anxiety Disorder Mood Disorder Affective Disorder Anxiety Disorder Drug Therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 781
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the safety and efficacy of 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, 5 mg or 10 mg of vortioxetine, once daily, 60 mg of duloxetine once daily, or a placebo once daily for eight weeks.

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. Participants who complete the 8-week treatment period will enter a 2-week discontinuation period in order to assess potential discontinuation symptoms. Total commitment time is up to 12 weeks.

Arms:
arm 1: Placebo-matching capsules, orally, once daily for up to 9 weeks. arm 2: Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week. arm 3: Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week. arm 4: Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week. arm 5: Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.

Interventions: intervention 1: Placebo intervention 2: Vortioxetine intervention 3: Duloxetine
Intervention descriptions: intervention 1: Placebo-matching capsules intervention 2: Encapsulated vortioxetine immediate release tablets intervention 3: Overencapsulated duloxetine capsules

Protocol document: