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

NCT ID: NCT00788034

Last Updated: 2015-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 459 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-07-31

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.

Conditions

Generalized Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lu AA21004

Group Type: EXPERIMENTAL

Lu AA21004

Intervention Type: DRUG

5 or 10 mg/day

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Once daily

Interventions

Lu AA21004

5 or 10 mg/day

Intervention Type: DRUG

Placebo

Once daily

Intervention Type: DRUG

Other Intervention Names

Vortioxetine

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@lundbeck.com

Locations

AR010

Buenos Aires, , Argentina

AR012

Buenos Aires, , Argentina

AR002

Buenos Aires, , Argentina

AR008

Buenos Aires, , Argentina

AR003

Buenos Aires, , Argentina

AR013

Buenos Aires, , Argentina

AR004

Córdoba, , Argentina

AR015

La Plata, , Argentina

AR006

Mendoza, , Argentina

AR009

Mendoza, , Argentina

AR001

Santa Fé, , Argentina

CL004

Antofagasta, , Chile

CL001

Coquimbo, , Chile

CL002

Santiago, , Chile

CL003

Santiago, , Chile

CL005

Santiago, , Chile

CL007

Santiago, , Chile

CL008

Santiago, , Chile

CL006

Viña del Mar, , Chile

CO003

Barranquilla, , Colombia

CO001

Bogotá, , Colombia

CO005

Bogotá, , Colombia

CO006

Envigado, , Colombia

CO002

Medellín, , Colombia

CO007

Medellín, , Colombia

CO004

Pareira, , Colombia

CR002

Escazú, , Costa Rica

CR004

Guadalupe, , Costa Rica

CR001

San José, , Costa Rica

CR003

San Pedro, , Costa Rica

EE001

Tallinn, , Estonia

EE004

Tallinn, , Estonia

EE002

Tartu, , Estonia

FI006

Espoo, , Finland

FI008

Helsinki, , Finland

FI001

Helsinki, , Finland

FI004

Helsinki, , Finland

FI011

Helsinki, , Finland

FI010

Helsinki, , Finland

FI005

Juväskylä, , Finland

FI012

Kuopio, , Finland

FI002

Oulu, , Finland

FI009

Rauma, , Finland

FI003

Turku, , Finland

FI007

Turku, , Finland

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

FR015

Toulouse, , France

FR005

Toulouse, , France

HU005

Budapest, , Hungary

HU004

Budapest, , Hungary

HU002

Budapest, , Hungary

HU001

Gyula, , Hungary

HU006

Nagykálló, , Hungary

HU008

Sopron, , Hungary

PE003

Lima, , Peru

PE002

Lima, , Peru

RU004

Chita, , Russia

RU006

Saint Petersburg, , Russia

RU002

Saint Petersburg, , Russia

RU003

Saint Petersburg, , Russia

RU001

Tomsk, , Russia

ZA006

Bloemfontein, , South Africa

ZA004

Cape Town, , South Africa

ZA011

Cape Town, , South Africa

ZA012

Cape Town, , South Africa

ZA003

Cape Town, , South Africa

ZA010

Cape Town, , South Africa

ZA007

Gauteng, , South Africa

ZA001

Gauteng, , South Africa

ZA009

Gauteng, , South Africa

ZA002

Kempton Park, , South Africa

ZA008

KwaZulu Natal, , South Africa

ZA005

Welkom, , South Africa

Countries

Argentina; Chile; Colombia; Costa Rica; Estonia; Finland; France; Hungary; Peru; Russia; South Africa

References

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.

Reference Type: RESULT

PMID: 22475889 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29081307 (View on PubMed)

Other Identifiers

2008-001673-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

12473A

Identifier Type: -

Identifier Source: org_study_id