Relapse-prevention Study With Lu AA21004 (Vortioxetine) in Patients With Generalized Anxiety Disorder

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will evaluate the long-term maintenance of efficacy of Lu AA21004 in patients with Generalized Anxiety Disorder (GAD) who responded to acute treatment with Lu AA21004.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lundbeck A/S
• Treatments: Vortioxetine

Criteria

Inclusion Criteria:

The patient has GAD as the primary diagnosis according to DSM-IV-TR criteria (classification code 300.02).

• The patient has a HAM-A total score >=20 at screening and baseline visits

• The patient has a HAM-A score >=2 on both Item 1 (anxious mood) and Item 2 (tension) at screening and baseline visits

• The patient has a MADRS total score <=16 at screening and baseline visits

Exclusion Criteria:

• Any current psychiatric disorder other than GAD as defined in the DSM-IV-TR (assessed with the MINI)

• Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR

• Women of childbearing potential not using effective contraception

Other protocol-defined inclusion and exclusion criteria may apply.