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

Phase 2

Completed

• Conditions: Social Phobia

• Registration Number: NCT00191022
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Study Completion: 2007-01
• Status Verified: 2007-02
• Last Update Submitted: 2007-02-12
• Last Update Posted: 2007-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test; 🇺🇸 West Allis, Wisconsin, United States