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

Primary Purpose

Generalized Social Phobia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
atomoxetine
placebo
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Social Phobia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    Atomoxetine

    Placebo

    Outcomes

    Primary Outcome Measures

    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".

    Secondary Outcome Measures

    Full Information

    First Posted
    November 29, 2005
    Last Updated
    May 19, 2016
    Sponsor
    University of California, San Diego
    Collaborators
    Eli Lilly and Company
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00260533
    Brief Title
    Efficacy and Tolerability of Atomoxetine (Strattera) in Adult Patients With Generalized Social Anxiety Disorder
    Official Title
    Double Blind Placebo Controlled Parallel Group Comparison of Atomoxetine (Strattera) for Generalized Social Anxiety Disorder (GSAD)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2005 (undefined)
    Primary Completion Date
    July 2008 (Actual)
    Study Completion Date
    July 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, San Diego
    Collaborators
    Eli Lilly and Company

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Generalized Social Phobia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    27 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Atomoxetine
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    atomoxetine
    Other Intervention Name(s)
    Strattera
    Intervention Description
    Flexible dose, up to 50 mg per day
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    placebo (matching to atomoxetine)
    Primary Outcome Measure Information:
    Title
    Clinical Global Impression (Change Version, Also Known as Improvement Version)
    Description
    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".
    Time Frame
    10 weeks (end of study)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Murray B Stein, M.D.
    Organizational Affiliation
    University of California, San Diego
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19910721
    Citation
    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.
    Results Reference
    result
    Links:
    URL
    http://www.veryshy.org
    Description
    UCSD Anxiety Disorders Research Program

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

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