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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00788034
• Other study ID #: 12473A
• Secondary ID: 2008-001673-15
• Status: Completed
• Phase: Phase 3
• First received: November 7, 2008
• Last updated: June 22, 2015
• Start date: October 2008
• Est. completion date: July 2010

Study information

• Verified date: December 2012
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaChile: Comisión Nacional de Investigación Científica y TecnológicaColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosCosta Rica: Ministry of Health Costa RicaEstonia: The State Agency of MedicineFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Hungary: National Institute of PharmacyPeru: General Directorate of Pharmaceuticals, Devices, and DrugsRussia: Ministry of Health of the Russian FederationSouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial 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.

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 worrying that persists over time for more than six months. Common features include apprehension, with worries about future misfortune; inner tension and difficulty in concentrating; motor tension, with restlessness, tremor and headache; and autonomic anxiety symptoms, with excessive perspiration, dry mouth and epigastric discomfort. GAD is typically a chronic disorder with a high relapse rate and therefore requires effective long-term treatment. Long-term studies are necessary to demonstrate that the short-term effect is maintained.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Drug:
• Lu AA21004
5 or 10 mg/day
• Placebo
Once daily

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

Argentina,  Chile,  Colombia,  Costa Rica,  Estonia,  Finland,  France,  Hungary,  Peru,  Russian Federation,  South Africa, 

References & Publications (1)

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

Outcome

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