Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Murray B. Stein, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00260533
First received: November 29, 2005
Last updated: December 28, 2011
Last verified: December 2011
History of Changes
  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 2
Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

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
Experimental: 1
Atomoxetine
 Drug: atomoxetine
Flexible dose, up to 50 mg per day
Other Name: Strattera
Placebo Comparator: 2
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

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

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

Publications:

Responsible Party: Murray B. Stein, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00260533     History of Changes
Other Study ID Numbers: 040100
Study First Received: November 29, 2005
Last Updated: December 28, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anxiety Disorders
Phobic Disorders
Mental Disorders
Atomoxetine
Adrenergic Uptake Inhibitors
Adrenergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013