Overview

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

Status:
Completed
Trial end date:
2008-07-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of California, San Diego
Collaborator:
Eli Lilly and Company
Treatments:
Atomoxetine Hydrochloride
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