Official Title: “Double Blind Placebo Controlled Parallel Group Comparison of Atomoxetine (Strattera) for Generalized Social Anxiety Disorder (GSAD)”

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).

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2009

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.

Intervention(s) in this Clinical Trial

• Drug: atomoxetine
  • Flexible dose, up to 50 mg per day
• Drug: placebo
  • placebo (matching to atomoxetine)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Atomoxetine
• Placebo Comparator: 2
  • Placebo

Primary Measures

• Clinical Global Impressions (Change Version)
  • Time Frame: 10 weeks (end of study)
    Safety Issue?: No

Secondary Measures

• Liebowitz Social Anxiety Scale (LSAS)
  • Time Frame: 10 weeks (end of study)
    Safety Issue?: No
• Sheehan Disability Scale
  • Time Frame: 10 weeks (end of study)
    Safety Issue?: No
• Hamilton Depression Rating Scale
  • Time Frame: 10 weeks (end of study)
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of California, San Diego

Overall Clinical Trial Officials and Contacts

Murray B Stein, M.D. Principal Investigator University of California, San Diego  

Overall Contact: Lakshmi Ravindran, MD 858-534-6400 lravindran@ucsd.edu

Information obtained from ClinicalTrials.gov on September 08, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00260533

Study ID Number: 040100

ClinicalTrials.gov Identifier: NCT00260533

Health Authority: United States: Institutional Review Board

UCSD Anxiety Disorders Research Program