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

NCT00260533 | Completed Phase 2 Results

• 1 other identifier: 040100
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Generalized Social Phobia

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impression (Change Version, Also Known as Improvement Version)

  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".

  10 weeks (end of study)

Study Arms (2)

1

EXPERIMENTAL

Atomoxetine

Drug: atomoxetine

2

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

atomoxetine DRUG

Flexible dose, up to 50 mg per day

Also known as: Strattera

1

placebo DRUG

placebo (matching to atomoxetine)

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and Women, ages 18-65, in good general health
• Meet DSM-IV criteria for Social Anxiety Disorder

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• Eli Lilly and Company: collaborator

Related 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.

  PMID: 19910721 RESULT

Related Links

• UCSD Anxiety Disorders Research Program

MeSH Terms

Interventions

Atomoxetine Hydrochloride

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Limitations and Caveats

Small study, with possibility of Type II error. Nonetheless, response rates in both arms were very low, making it unlikely that the failure to see a response to atomoxetine was due to low power compared to placebo.

Results Point of Contact

• Title: Murray B. Stein MD, MPH
• Organization: University of California San Diego

mstein@ucsd.edu

858-534-6400

Study Officials

• Murray B Stein, M.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 29, 2005
• First Posted: December 1, 2005
• Study Start: November 1, 2005
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: June 24, 2016
• Results First Posted: March 11, 2014

Record last verified: 2016-05