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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

459

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Oct 2008

Geographic Reach

10 countries

77 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.7 years study duration

Study Start

First participant enrolled

October 1, 2008

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

November 7, 2008

Completed

3 days until next milestone

First Posted

Study publicly available on registry

November 10, 2008

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed

Last Updated

June 23, 2015

Status Verified

December 1, 2012

Enrollment Period

1.7 years

First QC Date

November 7, 2008

Last Update Submit

June 22, 2015

Conditions

Generalized Anxiety Disorder

Keywords

Relapse preventionGADMaintenanceDouble-blindMulticentre

Outcome Measures

Primary Outcomes (1)

Time to relapse
At least 24 weeks

Secondary Outcomes (1)

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

Study Arms (2)

Lu AA21004

EXPERIMENTAL

Drug: Lu AA21004

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Lu AA21004DRUG

5 or 10 mg/day

Also known as: Vortioxetine

Lu AA21004

PlaceboDRUG

Once daily

Placebo

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

H. Lundbeck A/Slead

Study Sites (81)

AR010

Buenos Aires, 1900, Argentina

Location

AR012

Buenos Aires, B1900BHE, Argentina

Location

AR002

Buenos Aires, C1117ABH, Argentina

Location

AR008

Buenos Aires, C1405BOA, Argentina

Location

AR003

Buenos Aires, C1425AHQ, Argentina

Location

AR013

Buenos Aires, C1428AAQ, Argentina

Location

AR004

Córdoba, 5000, Argentina

Location

AR015

La Plata, 1900, Argentina

Location

AR006

Mendoza, M5500BCR, Argentina

Location

AR009

Mendoza, M5502BKH, Argentina

Location

AR001

Santa Fé, S2000QJI, Argentina

Location

CL004

Antofagasta, Chile

Location

CL001

Coquimbo, Chile

Location

CL002

Santiago, Chile

Location

CL003

Santiago, Chile

Location

CL005

Santiago, Chile

Location

CL007

Santiago, Chile

Location

CL008

Santiago, Chile

Location

CL006

Viña del Mar, Chile

Location

CO003

Barranquilla, Colombia

Location

CO001

Bogotá, Colombia

Location

CO005

Bogotá, Colombia

Location

CO006

Envigado, Colombia

Location

CO002

Medellín, Colombia

Location

CO007

Medellín, Colombia

Location

CO004

Pareira, Colombia

Location

CR002

Escazú, Costa Rica

Location

CR004

Guadalupe, Costa Rica

Location

CR001

San José, Costa Rica

Location

CR003

San Pedro, Costa Rica

Location

EE001

Tallinn, 10613, Estonia

Location

EE004

Tallinn, 13517, Estonia

Location

EE002

Tartu, 50417, Estonia

Location

FI006

Espoo, 2650, Finland

Location

FI008

Helsinki, 00260, Finland

Location

FI001

Helsinki, 00530, Finland

Location

FI004

Helsinki, 100, Finland

Location

FI011

Helsinki, 100, Finland

Location

FI010

Helsinki, 99, Finland

Location

FI005

Juväskylä, 40100, Finland

Location

FI012

Kuopio, 70110, Finland

Location

FI002

Oulu, 90100, Finland

Location

FI009

Rauma, 26100, Finland

Location

FI003

Turku, 20100, Finland

Location

FI007

Turku, 20100, Finland

Location

FR011

Arcachon, 33120, France

Location

FR010

Caen, 14000, France

Location

FR016

Douai, 59500, France

Location

FR012

Nantes, 44000, France

Location

FR004

Nîmes, 30029, France

Location

FR013

Palaiseau, 91120, France

Location

FR007

Rennes, 35000, France

Location

FR001

Saint-André-de-Cubzac, 33240, France

Location

FR002

Strasbourg, 67000, France

Location

FR015

Toulouse, 31000, France

Location

FR005

Toulouse, 31200, France

Location

HU005

Budapest, 1036, Hungary

Location

HU004

Budapest, 1095, Hungary

Location

HU002

Budapest, 1135, Hungary

Location

HU001

Gyula, 5700, Hungary

Location

HU006

Nagykálló, 4320, Hungary

Location

HU008

Sopron, 9400, Hungary

Location

PE003

Lima, 27, Peru

Location

PE002

Lima, 41, Peru

Location

RU004

Chita, 672090, Russia

Location

RU006

Saint Petersburg, 192019, Russia

Location

RU002

Saint Petersburg, 193019, Russia

Location

RU003

Saint Petersburg, 193019, Russia

Location

RU001

Tomsk, 634014, Russia

Location

ZA006

Bloemfontein, 9033, South Africa

Location

ZA004

Cape Town, 1, South Africa

Location

ZA011

Cape Town, 7130, South Africa

Location

ZA012

Cape Town, 7130, South Africa

Location

ZA003

Cape Town, 7140, South Africa

Location

ZA010

Cape Town, 7620, South Africa

Location

ZA007

Gauteng, 157, South Africa

Location

ZA001

Gauteng, 2195, South Africa

Location

ZA009

Gauteng, 7500, South Africa

Location

ZA002

Kempton Park, 1620, South Africa

Location

ZA008

KwaZulu Natal, 3630, South Africa

Location

ZA005

Welkom, 9459, South Africa

Location

Related Publications (2)

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.
PMID: 22475889RESULT
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.
PMID: 29081307DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@lundbeck.com
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 7, 2008

First Posted

November 10, 2008

Study Start

October 1, 2008

Primary Completion

June 1, 2010

Study Completion

July 1, 2010

Last Updated

June 23, 2015

Record last verified: 2012-12

Locations

CL(8)CO(7)RU(5)HU(6)ES(3)PE(2)ZA(12)FR(11)AR(11)FI(12)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Lu AA21004

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (81)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations