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Generalized Anxiety DisorderPhase 3NCT00788034

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

A Phase 3 study testing Lu AA21004 in people with Generalized Anxiety Disorder, run by H. Lundbeck A/S at 81 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Generalized Anxiety Disorder
What is being tested?
Lu AA21004
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
459 participants
Where
81 sitesin 11 countries
Study dates
Oct 2008to Jul 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

81 sites in 11 countries.

81 sites in 11 countries

Finland12 sites

  • FI006

    Espoo, 2650

  • FI008

    Helsinki, 00260

  • FI001

    Helsinki, 00530

  • FI004

    Helsinki, 100

  • FI011

    Helsinki, 100

  • FI010

    Helsinki, 99

  • FI005

    Juväskylä, 40100

  • FI012

    Kuopio, 70110

  • FI002

    Oulu, 90100

  • FI009

    Rauma, 26100

  • FI003

    Turku, 20100

  • FI007

    Turku, 20100

Other trials in Finland

South Africa12 sites

  • ZA006

    Bloemfontein, 9033

  • ZA004

    Cape Town, 1

  • ZA011

    Cape Town, 7130

  • ZA012

    Cape Town, 7130

  • ZA003

    Cape Town, 7140

  • ZA010

    Cape Town, 7620

  • ZA007

    Gauteng, 157

  • ZA001

    Gauteng, 2195

  • ZA009

    Gauteng, 7500

  • ZA002

    Kempton Park, 1620

  • ZA008

    KwaZulu Natal, 3630

  • ZA005

    Welkom, 9459

Other trials in South Africa

Argentina11 sites

  • AR010

    Buenos Aires, 1900

  • AR012

    Buenos Aires, B1900BHE

  • AR002

    Buenos Aires, C1117ABH

  • AR008

    Buenos Aires, C1405BOA

  • AR003

    Buenos Aires, C1425AHQ

  • AR013

    Buenos Aires, C1428AAQ

  • AR004

    Córdoba, 5000

  • AR015

    La Plata, 1900

  • AR006

    Mendoza, M5500BCR

  • AR009

    Mendoza, M5502BKH

  • AR001

    Santa Fe, S2000QJI

Other trials in Argentina

France11 sites

  • FR011

    Arcachon, 33120

  • FR010

    Caen, 14000

  • FR016

    Douai, 59500

  • FR012

    Nantes, 44000

  • FR004

    Nîmes, 30029

  • FR013

    Palaiseau, 91120

  • FR007

    Rennes, 35000

  • FR001

    Saint-André-de-Cubzac, 33240

  • FR002

    Strasbourg, 67000

  • FR015

    Toulouse, 31000

  • FR005

    Toulouse, 31200

Other trials in France

Chile8 sites

  • CL004

    Antofagasta

  • CL001

    Coquimbo

  • CL002

    Santiago

  • CL003

    Santiago

  • CL005

    Santiago

  • CL007

    Santiago

  • CL008

    Santiago

  • CL006

    Viña del Mar

Other trials in Chile

Colombia7 sites

  • CO003

    Barranquilla

  • CO001

    Bogotá

  • CO005

    Bogotá

  • CO006

    Envigado

  • CO002

    Medellín

  • CO007

    Medellín

  • CO004

    Pareira

Other trials in Colombia

Hungary6 sites

  • HU005

    Budapest, 1036

  • HU004

    Budapest, 1095

  • HU002

    Budapest, 1135

  • HU001

    Gyula, 5700

  • HU006

    Nagykálló, 4320

  • HU008

    Sopron, 9400

Other trials in Hungary

Russia5 sites

  • RU004

    Chita, 672090

  • RU006

    Saint Petersburg, 192019

  • RU002

    Saint Petersburg, 193019

  • RU003

    Saint Petersburg, 193019

  • RU001

    Tomsk, 634014

Other trials in Russia

Costa Rica4 sites

  • CR002

    Escazú

  • CR004

    Guadalupe

  • CR001

    San José

  • CR003

    San Pedro

Other trials in Costa Rica

Estonia3 sites

  • EE001

    Tallinn, 10613

  • EE004

    Tallinn, 13517

  • EE002

    Tartu, 50417

Other trials in Estonia

Peru2 sites

  • PE003

    Lima, 27

  • PE002

    Lima, 41

Other trials in Peru

About this study

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.

Read the 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.

Being tested
Lu AA21004, Placebo
Keywords
Relapse prevention, GAD, Maintenance, Double-blind, Multicentre
Medical subject headings
Generalized Anxiety Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lu AA21004Drug

    Also called Vortioxetine

    5 or 10 mg/day

  • PlaceboDrug

    Once daily

Study groups in NCT00788034
Study groupRoleWhat they receive
Lu AA21004ExperimentalNot described
Receives: Drug: Lu AA21004
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to relapse

    Measured: At least 24 weeks

Secondary outcomes (1)

  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

    Measured: At least 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionJun 2010
  4. Study completionJul 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
459 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00788034
Sponsor's protocol ID
12473A
Other IDs
2008-001673-15, 2008
Status last verified
Dec 2012
First submitted
7 Nov 2008
Last updated
23 Jun 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22475889

  • 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.

    PubMed 29081307

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lu AA21004 in people with Generalized Anxiety Disorder, run by H. Lundbeck A/S at 81 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in Finland, South Africa, Argentina, France, Chile and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to relapse (time frame: At least 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00788034, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2015.

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