Efficacy and Tolerability of Atomoxetine (Strattera) in Adult Patients With Generalized Social Anxiety Disorder - Full Text View

Sponsors and Collaborators:	University of California, San Diego Eli Lilly and Company
Information provided by:	University of California, San Diego
ClinicalTrials.gov Identifier:	NCT00260533

Purpose

The purpose of this study is to determine the effectiveness and tolerability of atomoxetine (Strattera) in adult patients with generalized social anxiety disorder (an anxiety disorder characterized by a fear of interpersonal interactions).

Condition	Intervention	Phase
Generalized Social Anxiety Disorder	Drug: atomoxetine Drug: placebo	Phase II Phase III

MedlinePlus related topics: Anxiety

Drug Information available for: Atomoxetine Atomoxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Double Blind Placebo Controlled Parallel Group Comparison of Atomoxetine (Strattera) for Generalized Social Anxiety Disorder (GSAD)

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:

Clinical Global Impressions (Change Version) [ Time Frame: 10 weeks (end of study) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: 10 weeks (end of study) ] [ Designated as safety issue: No ]
Sheehan Disability Scale [ Time Frame: 10 weeks (end of study) ] [ Designated as safety issue: No ]
Hamilton Depression Rating Scale [ Time Frame: 10 weeks (end of study) ] [ Designated as safety issue: No ]

Enrollment:	27
Study Start Date:	November 2005
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Atomoxetine	Drug: atomoxetine Flexible dose, up to 50 mg per day
2: Placebo Comparator Placebo	Drug: placebo placebo (matching to atomoxetine)

Detailed Description:

Controlled studies show that approximately 50% of patients with generalized social anxiety disorder(GSAD)will respond to treatment with available pharmacotherapeutic agents such as SSRI's. This still leaves 50% that respond partially or not at all. Those who do respond, often experience adverse events (e.g., sexual dysfunction), which leads them to discontinue treatment. Thus, there is a strong rational for identifying alternatives to SSRI's that are effective with fewer side effects (or with a different side-effect profile, that features less sexual dysfunction)for the treatment of GSAD. Available data demonstrate that sustained-release venlafaxine, a dual reuptake inhibitor, is also effective for GSAD.(Stein et al., 2005). It is unclear from these studies whether serotonin reuptake is integral to efficacy for social anxiety disorder, or whether norepinephrine reuptake will convey similar efficacy. Atomoxetine (Strattera)an inhibitor of the presynaptic norepinephrine transporter, is an ideal candidate to address both these issues.

Eligibility

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

Criteria

Inclusion Criteria:

Men and Women, ages 18-65, in good general health
Meet DSM-IV criteria for Social Anxiety Disorder

Exclusion Criteria:

Pregnant or breastfeeding
Narrow angle glaucoma
Any uncontrolled medical condition or any medical condition which would represent a contraindication to atomoxetine (Strattera) pharmacotherapy (e.g., hepatic insufficiency, untreated hypertension, untreated cardiovascular or cerebrovascular disease)
Any concomitant non-psychotropic medications that the physician determines are a contraindication to atomoxetine (Strattera) pharmacotherapy (e.g., Albuterol, various pressor agents)
Bipolar disorder, or any psychotic or organic mental disorder or dementia
Current substance abuse or dependency
Current active suicidal ideation
Current use of herbal psychoactive treatments such as St. John's Wort
Concurrent psychotropic medication is not permitted for 2 weeks prior to randomization (4 weeks in the case of fluoxetine) or at any point thereafter.
Receipt of formal psychotherapy concurrently
Inability, in the investigator's opinion, to comply with study procedures or assessments

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260533

Locations

United States, California
La Jolla Professional Bldg.
La Jolla, California, United States, 92037

Sponsors and Collaborators

University of California, San Diego

Eli Lilly and Company

Investigators

Principal Investigator:

Murray B Stein, M.D.

University of California, San Diego

More Information

UCSD Anxiety Disorders Research Program This link exits the ClinicalTrials.gov site

Responsible Party:	University of California San Diego ( Murray B. Stein MD, MPH, Professor )
Study ID Numbers:	040100
Study First Received:	November 29, 2005
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00260533
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Atomoxetine
Phobic Disorders

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action

Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009