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

Generalized Social Phobia Clinical Trial

Official title:

Double Blind Placebo Controlled Parallel Group Comparison of Atomoxetine (Strattera) for Generalized Social Anxiety Disorder (GSAD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00260533
• Other study ID #: 040100
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 29, 2005
• Last updated: January 24, 2014
• Start date: November 2005
• Est. completion date: July 2008

Study information

• Verified date: January 2014
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Social Phobia
• Phobic Disorders

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	Eli Lilly and Company

References & Publications (1)

Ravindran LN, Kim DS, Letamendi AM, Stein MB. A randomized controlled trial of atomoxetine in generalized social anxiety disorder. J Clin Psychopharmacol. 2009 Dec;29(6):561-4. doi: 10.1097/JCP.0b013e3181bf6303. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impressions (Change Version)	This is a commonly used, clinician-rated measure of clinical improvement. For purposes of analysis, subjects rated as "Very Much Improved" or "Much Improved" were considered responders.	10 weeks (end of study)	No

External Links

•   UCSD Anxiety Disorders Research Program