Status:
COMPLETED
Relapse-prevention Study With Lu AA21004 (Vortioxetine) in Patients With Generalized Anxiety Disorder
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Generalized Anxiety Disorder
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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.
Detailed Description
GAD is a common and disabling mental disorder associated with substantial medical and psychiatric comorbidity and occupational impairment. It is characterized by inappropriate or excessive anxiety and...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
459 Patients enrolled
Trial Details
Trial ID
NCT00788034
Start Date
October 1 2008
End Date
July 1 2010
Last Update
June 23 2015
Active Locations (81)
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1
AR010
Buenos Aires, Argentina, 1900
2
AR012
Buenos Aires, Argentina, B1900BHE
3
AR002
Buenos Aires, Argentina, C1117ABH
4
AR008
Buenos Aires, Argentina, C1405BOA