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

June 22, 2015 updated by: H. Lundbeck A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

459

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1900
        • AR010
      • Buenos Aires, Argentina, B1900BHE
        • AR012
      • Buenos Aires, Argentina, C1117ABH
        • AR002
      • Buenos Aires, Argentina, C1405BOA
        • AR008
      • Buenos Aires, Argentina, C1425AHQ
        • AR003
      • Buenos Aires, Argentina, C1428AAQ
        • AR013
      • Cordoba, Argentina, 5000
        • AR004
      • La Plata, Argentina, 1900
        • AR015
      • Mendoza, Argentina, M5500BCR
        • AR006
      • Mendoza, Argentina, M5502BKH
        • AR009
      • Santa Fé, Argentina, S2000QJI
        • AR001
  • Chile
      • Antofagasta, Chile
        • CL004
      • Coquimbo, Chile
        • CL001
      • Santiago, Chile
        • CL002
      • Santiago, Chile
        • CL003
      • Santiago, Chile
        • CL005
      • Santiago, Chile
        • CL007
      • Santiago, Chile
        • CL008
      • Vina del Mar, Chile
        • CL006
  • Colombia
      • Barranquilla, Colombia
        • CO003
      • Bogotá, Colombia
        • CO001
      • Bogotá, Colombia
        • CO005
      • Envigado, Colombia
        • CO006
      • Medellin, Colombia
        • CO002
      • Medellin, Colombia
        • CO007
      • Pareira, Colombia
        • CO004
  • Costa Rica
      • Escazu, Costa Rica
        • CR002
      • Guadalupe, Costa Rica
        • CR004
      • San José, Costa Rica
        • CR001
      • San Pedro, Costa Rica
        • CR003
  • Estonia
      • Tallinn, Estonia, 10613
        • EE001
      • Tallinn, Estonia, 13517
        • EE004
      • Tartu, Estonia, 50417
        • EE002
  • Finland
      • Espoo, Finland, 2650
        • FI006
      • Helsinki, Finland, 00260
        • FI008
      • Helsinki, Finland, 00530
        • FI001
      • Helsinki, Finland, 100
        • FI004
      • Helsinki, Finland, 100
        • FI011
      • Helsinki, Finland, 99
        • FI010
      • Juväskylä, Finland, 40100
        • FI005
      • Kuopio, Finland, 70110
        • FI012
      • Oulu, Finland, 90100
        • FI002
      • Rauma, Finland, 26100
        • FI009
      • Turku, Finland, 20100
        • FI003
      • Turku, Finland, 20100
        • FI007
  • France
      • Arcachon, France, 33120
        • FR011
      • Caen, France, 14000
        • FR010
      • Douai, France, 59500
        • FR016
      • Nantes, France, 44000
        • FR012
      • Nîmes, France, 30029
        • FR004
      • Palaiseau, France, 91120
        • FR013
      • Rennes, France, 35000
        • FR007
      • Saint-André-de-Cubzac, France, 33240
        • FR001
      • Strasbourg, France, 67000
        • FR002
      • Toulouse, France, 31000
        • FR015
      • Toulouse, France, 31200
        • FR005
  • Hungary
      • Budapest, Hungary, 1036
        • HU005
      • Budapest, Hungary, 1095
        • HU004
      • Budapest, Hungary, 1135
        • HU002
      • Gyula, Hungary, 5700
        • HU001
      • Nagykallo, Hungary, 4320
        • HU006
      • Sopron, Hungary, 9400
        • HU008
  • Peru
      • Lima, Peru, 27
        • PE003
      • Lima, Peru, 41
        • PE002
  • Russian Federation
      • Chita, Russian Federation, 672090
        • RU004
      • St. Petersburg, Russian Federation, 192019
        • RU006
      • St. Petersburg, Russian Federation, 193019
        • RU002
      • St. Petersburg, Russian Federation, 193019
        • RU003
      • Tomsk, Russian Federation, 634014
        • RU001
  • South Africa
      • Bloemfontein, South Africa, 9033
        • ZA006
      • Cape Town, South Africa, 1
        • ZA004
      • Cape Town, South Africa, 7130
        • ZA011
      • Cape Town, South Africa, 7130
        • ZA012
      • Cape Town, South Africa, 7140
        • ZA003
      • Cape Town, South Africa, 7620
        • ZA010
      • Gauteng, South Africa, 157
        • ZA007
      • Gauteng, South Africa, 2195
        • ZA001
      • Gauteng, South Africa, 7500
        • ZA009
      • Kempton Park, South Africa, 1620
        • ZA002
      • KwaZulu Natal, South Africa, 3630
        • ZA008
      • Welkom, South Africa, 9459
        • ZA005

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Once daily
Experimental: Lu AA21004
Drug: Lu AA21004
5 or 10 mg/day
Other Names:
  • Vortioxetine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to relapse
Time Frame: At least 24 weeks
At least 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: At least 24 weeks
At least 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

November 7, 2008

First Submitted That Met QC Criteria

November 7, 2008

First Posted (Estimate)

November 10, 2008

Study Record Updates

Last Update Posted (Estimate)

June 23, 2015

Last Update Submitted That Met QC Criteria

June 22, 2015

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12473A
  • 2008-001673-15 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe