Efficacy and Tolerability of Atomoxetine (Strattera) in Adult Patients With Generalized Social Anxiety Disorder
This study has been completed.
Eli Lilly and Company
Information provided by (Responsible Party):
Murray B. Stein, University of California, San Diego
First received: November 29, 2005
Last updated: May 19, 2016
Last verified: May 2016
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).
Generalized Social Phobia
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||Double Blind Placebo Controlled Parallel Group Comparison of Atomoxetine (Strattera) for Generalized Social Anxiety Disorder (GSAD)
Primary Outcome Measures:
- Clinical Global Impression (Change Version, Also Known as Improvement Version) [ Time Frame: 10 weeks (end of study) ] [ Designated as safety issue: No ]
This is a commonly used, clinician-rated measure of clinical improvement.
The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
For purposes of analysis, subjects rated as "(1) Very Much Improved" or "(2) Much Improved" were considered "responders".
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2008 (Final data collection date for primary outcome measure)
Flexible dose, up to 50 mg per day
Other Name: Strattera
Placebo Comparator: 2
placebo (matching to atomoxetine)
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.
|Ages Eligible for Study:
||18 Years to 65 Years (Adult)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Men and Women, ages 18-65, in good general health
- Meet DSM-IV criteria for Social Anxiety Disorder
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00260533
University of California, San Diego
Eli Lilly and Company
||Murray B Stein, M.D.
||University of California, San Diego
||Murray B. Stein, Professor, University of California, San Diego
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 29, 2005
|Results First Received:
||June 13, 2012
||May 19, 2016
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 23, 2016
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs