Social Phobia
Conditions
Brief summary
This study is a Phase 2 trial to test the efficacy of LY686017 in the treatment of Social Anxiety Disorder.
Interventions
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 | — |
| To compare the safety and tolerability of LY686017 with placebo during 12-week treatment. | — |
| 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. | — |
| The Clinical Global Impression-Severity scale | — |
Countries
United States
Outcome results
None listed