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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-07-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Generalized Social Phobia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Atomoxetine

Group Type EXPERIMENTAL

atomoxetine

Intervention Type DRUG

Flexible dose, up to 50 mg per day

2

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo (matching to atomoxetine)

Interventions

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atomoxetine

Flexible dose, up to 50 mg per day

Intervention Type DRUG

placebo

placebo (matching to atomoxetine)

Intervention Type DRUG

Other Intervention Names

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Strattera

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No