Generalized Anxiety Disorder Clinical Trial
Official title:
A Double-blind, Randomised, Placebo-controlled, Multicentre, Relapse-prevention Study With Lu AA21004 in Patients With Generalized Anxiety Disorder
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.
Status | Completed |
Enrollment | 459 |
Est. completion date | July 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | AR002 | Buenos Aires | |
Argentina | AR003 | Buenos Aires | |
Argentina | AR008 | Buenos Aires | |
Argentina | AR010 | Buenos Aires | |
Argentina | AR012 | Buenos Aires | |
Argentina | AR013 | Buenos Aires | |
Argentina | AR004 | Cordoba | |
Argentina | AR015 | La Plata | |
Argentina | AR006 | Mendoza | |
Argentina | AR009 | Mendoza | |
Argentina | AR001 | Santa Fé | |
Chile | CL004 | Antofagasta | |
Chile | CL001 | Coquimbo | |
Chile | CL002 | Santiago | |
Chile | CL003 | Santiago | |
Chile | CL005 | Santiago | |
Chile | CL007 | Santiago | |
Chile | CL008 | Santiago | |
Chile | CL006 | Vina del Mar | |
Colombia | CO003 | Barranquilla | |
Colombia | CO001 | Bogotá | |
Colombia | CO005 | Bogotá | |
Colombia | CO006 | Envigado | |
Colombia | CO002 | Medellin | |
Colombia | CO007 | Medellin | |
Colombia | CO004 | Pareira | |
Costa Rica | CR002 | Escazu | |
Costa Rica | CR004 | Guadalupe | |
Costa Rica | CR001 | San José | |
Costa Rica | CR003 | San Pedro | |
Estonia | EE001 | Tallinn | |
Estonia | EE004 | Tallinn | |
Estonia | EE002 | Tartu | |
Finland | FI006 | Espoo | |
Finland | FI001 | Helsinki | |
Finland | FI004 | Helsinki | |
Finland | FI008 | Helsinki | |
Finland | FI010 | Helsinki | |
Finland | FI011 | Helsinki | |
Finland | FI005 | Juväskylä | |
Finland | FI012 | Kuopio | |
Finland | FI002 | Oulu | |
Finland | FI009 | Rauma | |
Finland | FI003 | Turku | |
Finland | FI007 | Turku | |
France | FR011 | Arcachon | |
France | FR010 | Caen | |
France | FR016 | Douai | |
France | FR012 | Nantes | |
France | FR004 | Nîmes | |
France | FR013 | Palaiseau | |
France | FR007 | Rennes | |
France | FR001 | Saint-André-de-Cubzac | |
France | FR002 | Strasbourg | |
France | FR005 | Toulouse | |
France | FR015 | Toulouse | |
Hungary | HU002 | Budapest | |
Hungary | HU004 | Budapest | |
Hungary | HU005 | Budapest | |
Hungary | HU001 | Gyula | |
Hungary | HU006 | Nagykallo | |
Hungary | HU008 | Sopron | |
Peru | PE002 | Lima | |
Peru | PE003 | Lima | |
Russian Federation | RU004 | Chita | |
Russian Federation | RU002 | St. Petersburg | |
Russian Federation | RU003 | St. Petersburg | |
Russian Federation | RU006 | St. Petersburg | |
Russian Federation | RU001 | Tomsk | |
South Africa | ZA006 | Bloemfontein | |
South Africa | ZA003 | Cape Town | |
South Africa | ZA004 | Cape Town | |
South Africa | ZA010 | Cape Town | |
South Africa | ZA011 | Cape Town | |
South Africa | ZA012 | Cape Town | |
South Africa | ZA001 | Gauteng | |
South Africa | ZA007 | Gauteng | |
South Africa | ZA009 | Gauteng | |
South Africa | ZA002 | Kempton Park | |
South Africa | ZA008 | KwaZulu Natal | |
South Africa | ZA005 | Welkom |
Lead Sponsor | Collaborator |
---|---|
H. Lundbeck A/S |
Argentina, Chile, Colombia, Costa Rica, Estonia, Finland, France, Hungary, Peru, Russian Federation, South Africa,
Baldwin DS, Loft H, Florea I. Lu AA21004, a multimodal psychotropic agent, in the prevention of relapse in adult patients with generalized anxiety disorder. Int Clin Psychopharmacol. 2012 Jul;27(4):197-207. doi: 10.1097/YIC.0b013e3283530ad7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to relapse | At least 24 weeks | No | |
Secondary | Relapse rates, Hamilton Anxiety Rating Scale (HAM-A), Clinical Global Impression Scale (CGI), MOS SF-36, Sheehan Disability Scale (SDS), Adverse events, Clinical laboratory tests, Vital signs, ECG | At least 24 weeks | Yes |
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