Phase 3
N=27
Efficacy and Tolerability of Atomoxetine (Strattera) in Adult Patients With Generalized Social Anxiety Disorder
Generalized Social Phobia
Bottom Line
View on ClinicalTrials.gov: NCT00260533 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Clinical Global Impression (Change Version, Also Known as Improvement Version) — 3; 4 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- atomoxetine (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Global Impression (Change Version, Also Known as Improvement Version) |
3; 4 | — |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00260533). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.