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

Phase 2CompletedNCT00191022

Eli Lilly and Company185 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

185

Conditions

Social Phobia

Interventions

LY686017DRUG

paroxetineDRUG

placeboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (15)

Outcomes

Primary Outcomes

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 Outcomes

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.

Data from ClinicalTrials.gov

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Burbank, California, United States

Newport Beach, California, United States

Denver, Colorado, United States

New Britain, Connecticut, United States

Gainesville, Florida, United States

Indianapolis, Indiana, United States

Baltimore, Maryland, United States

Belmont, Massachusetts, United States

New York, New York, United States

Portland, Oregon, United States

...and 5 more locations