Efficacy of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder

Conditions

• Generalized Anxiety Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  Placebo-matching capsules
• Vortioxetine — DRUG
  Encapsulated vortioxetine immediate release tablets
• Duloxetine — DRUG
  Overencapsulated duloxetine capsules

Study Details

The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily (QD), in adults with generalized anxiety disorder.

Key Dates

Start date

Jun 30, 2008

Status verified

Oct 2013

Primary completion

Feb 28, 2009

Completion

Feb 28, 2009

Study Design

Enrollment

781 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Placebo-matching capsules, orally, once daily for up to 9 weeks.
• Experimental: Vortioxetine 2.5 mg
  Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
• Experimental: Vortioxetine 5 mg
  Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
• Experimental: Vortioxetine 10 mg
  Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
• Active Comparator: Duloxetine 60 mg
  Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.

Primary Outcome Measure

Change From Baseline in the Hamilton Anxiety (HAM-A) Scale Total Score at Week 8 [ Time Frame: Baseline to Week 8 ]

Locations (66)

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