Clinical trial NCT00788034: Relapse-prevention Study With Lu AA21004 (Vortioxetine) in Patients With Generalized Anxiety Disorder
Official title: A Double-blind, Randomised, Placebo-controlled, Multicentre, Relapse-prevention Study With Lu AA21004 in Patients With Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Generalized Anxiety Disorder
Keywords: Relapse prevention
GAD
Maintenance
Double-blind
Multicentre
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2008-11-10
Enrollment: 459
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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.

Primary outcomes:
measure: Time to relapse
timeFrame: At least 24 weeks
Secondary outcomes:
measure: 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
timeFrame: At least 24 weeks
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: AR010
city: Buenos Aires
country: Argentina
facility: AR012
city: Buenos Aires
country: Argentina
facility: AR002
city: Buenos Aires
country: Argentina
facility: AR008
city: Buenos Aires
country: Argentina
facility: AR003
city: Buenos Aires
country: Argentina
facility: AR013
city: Cordoba
country: Argentina
facility: AR004
city: La Plata
country: Argentina
facility: AR015
city: Mendoza
country: Argentina
facility: AR006
city: Mendoza
country: Argentina
facility: AR009
city: Santa Fé
country: Argentina
facility: AR001
city: Antofagasta
country: Chile
facility: CL004
city: Coquimbo
country: Chile
facility: CL001
city: Santiago
country: Chile
facility: CL002
city: Santiago
country: Chile
facility: CL003
city: Santiago
country: Chile
facility: CL005
city: Santiago
country: Chile
facility: CL007
city: Santiago
country: Chile
facility: CL008
city: Vina del Mar
country: Chile
facility: CL006
city: Barranquilla
country: Colombia
facility: CO003
city: Bogotá
country: Colombia
facility: CO001
city: Bogotá
country: Colombia
facility: CO005
city: Envigado
country: Colombia
facility: CO006
city: Medellin
country: Colombia
facility: CO002
city: Medellin
country: Colombia
facility: CO007
city: Pareira
country: Colombia
facility: CO004
city: Escazu
country: Costa Rica
facility: CR002
city: Guadalupe
country: Costa Rica
facility: CR004
city: San José
country: Costa Rica
facility: CR001
city: San Pedro
country: Costa Rica
facility: CR003
city: Tallinn
country: Estonia
facility: EE001
city: Tallinn
country: Estonia
facility: EE004
city: Tartu
country: Estonia
facility: EE002
city: Espoo
country: Finland
facility: FI006
city: Helsinki
country: Finland
facility: FI008
city: Helsinki
country: Finland
facility: FI001
city: Helsinki
country: Finland
facility: FI004
city: Helsinki
country: Finland
facility: FI011
city: Helsinki
country: Finland
facility: FI010
city: Juväskylä
country: Finland
facility: FI005
city: Kuopio
country: Finland
facility: FI012
city: Oulu
country: Finland
facility: FI002
city: Rauma
country: Finland
facility: FI009
city: Turku
country: Finland
facility: FI003
city: Turku
country: Finland
facility: FI007
city: Arcachon
country: France
facility: FR011
city: Caen
country: France
facility: FR010
city: Douai
country: France
facility: FR016
city: Nantes
country: France
facility: FR012
city: Nîmes
country: France
facility: FR004
city: Palaiseau
country: France
facility: FR013
city: Rennes
country: France
facility: FR007
city: Saint-André-de-Cubzac
country: France
facility: FR001
city: Strasbourg
country: France
facility: FR002
city: Toulouse
country: France
facility: FR015
city: Toulouse
country: France
facility: FR005
city: Budapest
country: Hungary
facility: HU005
city: Budapest
country: Hungary
facility: HU004
city: Budapest
country: Hungary
facility: HU002
city: Gyula
country: Hungary
facility: HU001
city: Nagykallo
country: Hungary
facility: HU006
city: Sopron
country: Hungary
facility: HU008
city: Lima
country: Peru
facility: PE003
city: Lima
country: Peru
facility: PE002
city: Chita
country: Russian Federation
facility: RU004
city: St. Petersburg
country: Russian Federation
facility: RU006
city: St. Petersburg
country: Russian Federation
facility: RU002
city: St. Petersburg
country: Russian Federation
facility: RU003
city: Tomsk
country: Russian Federation
facility: RU001
city: Bloemfontein
country: South Africa
facility: ZA006
city: Cape Town
country: South Africa
facility: ZA004
city: Cape Town
country: South Africa
facility: ZA011
city: Cape Town
country: South Africa
facility: ZA012
city: Cape Town
country: South Africa
facility: ZA003
city: Cape Town
country: South Africa
facility: ZA010
city: Gauteng
country: South Africa
facility: ZA007
city: Gauteng
country: South Africa
facility: ZA001
city: Gauteng
country: South Africa
facility: ZA009
city: Kempton Park
country: South Africa
facility: ZA002
city: KwaZulu Natal
country: South Africa
facility: ZA008
city: Welkom
country: South Africa
facility: ZA005
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Christensen MC, Loft H, Florea I, McIntyre RS. Efficacy of vortioxetine in working patients with generalized anxiety disorder. CNS Spectr. 2019 Apr;24(2):249-257. doi: 10.1017/S1092852917000761. Epub 2017 Oct 30.