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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00788034
First received: November 7, 2008
Last updated: December 7, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Generalized Anxiety Disorder
 Drug: Lu AA21004
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomised, Placebo-controlled, Multicentre, Relapse-prevention Study With Lu AA21004 in Patients With Generalized Anxiety Disorder

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • Time to relapse [ Time Frame: At least 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 459
Study Start Date: October 2008
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lu AA21004 Drug: Lu AA21004
5 or 10 mg/day
Other Name: Vortioxetine
Placebo Comparator: Placebo Drug: Placebo
Once daily

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00788034

  Show 81 Study Locations
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

Publications:

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00788034     History of Changes
Other Study ID Numbers: 12473A, 2008-001673-15
Study First Received: November 7, 2008
Last Updated: December 7, 2012
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Chile: Comisión Nacional de Investigación Científica y Tecnológica
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Costa Rica: Ministry of Health Costa Rica
Estonia: The State Agency of Medicine
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hungary: National Institute of Pharmacy
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Russia: Ministry of Health of the Russian Federation
South Africa: Medicines Control Council

Keywords provided by H. Lundbeck A/S:
Relapse prevention
GAD
Maintenance
Double-blind
Multicentre

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013