Comparison of LY686017 With a Marketed Drug in the Treatment of Social Anxiety Disorder

Study Overview
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Brief Summary
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This study is a Phase 2 trial to test the efficacy of LY686017 in the treatment of Social Anxiety Disorder.

Official Title
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A Randomized, Double-Blind Comparison of LY686017, Paroxetine, and Placebo in the Treatment of Social Anxiety Disorder

Conditions
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Social Phobia

Intervention / Treatment
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* Drug: LY686017
* Drug: paroxetine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female outpatients at least 18 years of age and not more than 65 years of age. Must sign the informed consent document. Present at Visit 1 with social anxiety disorder based on a Clinical Global Impression-Severity score of greater than or equal to 4. Females of childbearing potential (not surgically sterilized and between menarche and 1 year post-menopause) must test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use both a reliable primary method of birth control. Judged to be reliable and willing to keep all appointments for clinic visits, tests, and procedures required by the protocol. Exclusion Criteria: Have any comorbid Axis I disorders (such as major depression, obsessive compulsive disorder, post-traumatic stress disorder, or panic disorder), in the opinion of the investigator, if the disorder occurred within the last 6 months. Have had any previous or current diagnoses of bipolar disorders, schizophrenia, or other psychotic disorders. Have the presence of an Axis II disorder, except avoidant personality disorder. Have a serious medical illness. Have abnormal thyroid-stimulating hormone (TSH) concentrations or are taking thyroid supplements.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: LY686017|nan|
|Drug: paroxetine|nan|
|Drug: placebo|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superiority is defined as a statistically greater reduction of the mean change from baseline to endpoint (after 12 weeks of treatment) in the Liebowitz Social Anxiety Scale (LSAS) total score. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the safety and tolerability of LY686017 with placebo during 12-week treatment. |  |  | 
| To evaluate efficacy of LY686017 compared with placebo in treatment of social anxiety disorder during 12-week therapy based on mean improvement in the following measures: |  |  | 
| The Liebowitz Social Anxiety subscale scores |  |  | 
| The Clinical Global Impression-Improvement scale |  |  | 
| The Hamilton Anxiety Scale total score and |  |  | 
| The Clinical Global Impression-Severity scale |  |  | 
| To assess the efficacy of LY686017 compared with placebo on health outcomes as measured by the Sheehan Disability scale. |  |  | 
| To investigate the population pharmacokinetics of LY686017 following multiple administrations of LY686017. |  |  | 
| To ascertain whether another approved marketed drug for |  |  | 
| social anxiety disorder is statistically significantly more efficacious than placebo in this study. |  |  |