Efficacy and Safety of Escitalopram in Patients With Generalized Anxiety Disorder - Full Text View

Sponsor:	H. Lundbeck A/S
Information provided by:	H. Lundbeck A/S
ClinicalTrials.gov Identifier:	NCT00902564

Purpose

The purpose of this study is to evaluate efficacy of escitalopram after 8 weeks of treatment in patients with Generalized Anxiety Disorder (GAD), to evaluate proportion of patients who respond to escitalopram during the treatment period, and to evaluate safety of escitalopram.

Condition	Intervention	Phase
Generalized Anxiety Disorder	Drug: Escitalopram	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Escitalopram in Patients With Generalized Anxiety Disorder; Open-label, One Arm Postmarketing Study in Russia

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

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

Primary Outcome Measures:

Efficacy of escitalopram after 8 weeks of treatment in patients with GAD using Clinical Global Impression (CGI), Sheehan Disability Scale (SDS), and Hamilton Anxiety Scale (HAMA) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluation of proportion of patients who responded to escitalopram during 8 weeks of treatment using the CGI-I definition [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
To evaluate safety in patients with GAD treated with escitalopram [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	30
Study Start Date:	March 2009
Estimated Study Completion Date:	February 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Escitalopram: Experimental	Drug: Escitalopram Flexible-dosed (5 to 20mg/day) per os

Detailed Description:

The study will be performed in Russia, as an open-label, uncontrolled, one arm trial. The patients will receive escitalopram for 8 weeks. Start and maintenance dosages as well as dose titration will be left to the investigators' decision (5 to 20mg/day), in accordance with the national Summary of Products Characteristics (SPC).

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The patient suffers from GAD, diagnosed according to ICD-10
The patient meets criteria set in the national SPC for escitalopram
The patient is, in the opinion of the investigator, otherwise healthy on the basis of a physical examination, medical history and vital signs

Exclusion Criteria:

The patient has/has had an alcohol or drug abuse-related disorder, as defined in ICD-10
The patient has contraindications to escitalopram
The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to escitalopram
The patient has a serious illness and/or serious sequelae thereof, including liver or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance
The patient is pregnant or breast-feeding
The patient, if a woman of childbearing potential, is not using adequate contraception

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00902564

Locations

Russian Federation
RU001
Moscow, Russian Federation

Sponsors and Collaborators

H. Lundbeck A/S

Investigators

Study Director:

Email contact via H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

More Information

No publications provided

Responsible Party:	H. Lundbeck A/S ( H. Lundbeck A/S )
Study ID Numbers:	12132A
Study First Received:	May 14, 2009
Last Updated:	January 11, 2010
ClinicalTrials.gov Identifier:	NCT00902564 History of Changes
Health Authority:	Russia: Ministry of Health and Social Development of the Russian Federation

Keywords provided by H. Lundbeck A/S:

Generalized Anxiety Disorder
GAD
Antidepressant
Anxiolytic

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Pathologic Processes
Mental Disorders
Therapeutic Uses

Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents
Disease
Citalopram
Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Anxiety Disorders
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010