Relapse-Prevention Study With Lu AA21004 in Patients With Generalized Anxiety Disorder - Full Text View

Sponsored by:	H. Lundbeck A/S
Information provided by:	H. Lundbeck A/S
ClinicalTrials.gov Identifier:	NCT00788034

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 III

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Official Title:	A Double-Blind, Randomised, Placebo-Controlled, Multicentre, Relapse-Prevention Study With Lu AA21004 in Patients With Generalized Anxiety Disorder

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 ]

Estimated Enrollment:	300
Study Start Date:	October 2008
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Lu AA21004 5 or 10 mg/day
2: Placebo Comparator	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

Contacts

Contact: Email contact via H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

Locations

Finland
FI001	Recruiting
Helsinki, Finland, 00530

Sponsors and Collaborators

H. Lundbeck A/S

Investigators

Study Director:

Email contact via H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

More Information

Responsible Party:	H. Lundbeck A/S ( H. Lundbeck A/S )
Study ID Numbers:	12473A, EudraCT: 2008-001673-15
Study First Received:	November 7, 2008
Last Updated:	November 7, 2008
ClinicalTrials.gov Identifier:	NCT00788034
Health Authority:	Finland: National Agency for Medicines; Hungary: National Institute of Pharmacy

Keywords provided by H. Lundbeck A/S:

Relapse prevention
GAD
Maintenance
Double-blind
Multicentre

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 16, 2009