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

Primary Purpose

Social Phobia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LY686017
paroxetine
placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Phobia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
September 12, 2005
Last Updated
February 12, 2007
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00191022
Brief Title
Comparison of LY686017 With a Marketed Drug in the Treatment of Social Anxiety Disorder
Official Title
A Randomized, Double-Blind Comparison of LY686017, Paroxetine, and Placebo in the Treatment of Social Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Phobia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
185 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
LY686017
Intervention Type
Drug
Intervention Name(s)
paroxetine
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To compare the safety and tolerability of LY686017 with placebo during 12-week treatment.
Title
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:
Title
The Liebowitz Social Anxiety subscale scores
Title
The Clinical Global Impression-Improvement scale
Title
The Hamilton Anxiety Scale total score and
Title
The Clinical Global Impression-Severity scale
Title
To assess the efficacy of LY686017 compared with placebo on health outcomes as measured by the Sheehan Disability scale.
Title
To investigate the population pharmacokinetics of LY686017 following multiple administrations of LY686017.
Title
To ascertain whether another approved marketed drug for
Title
social anxiety disorder is statistically significantly more efficacious than placebo in this study.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM to 5PM EST (UTC/GMT - 5 hours EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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
City
Burbank
State/Province
California
ZIP/Postal Code
91506
Country
United States
Facility Name
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
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
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
City
Denver
State/Province
Colorado
ZIP/Postal Code
80212
Country
United States
Facility Name
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
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06052
Country
United States
Facility Name
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
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
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
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
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
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
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
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Facility Name
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
City
New York
State/Province
New York
ZIP/Postal Code
10024
Country
United States
Facility Name
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
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
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
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
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
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
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
City
Herndon
State/Province
Virginia
ZIP/Postal Code
20170
Country
United States
Facility Name
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
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
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
City
West Allis
State/Province
Wisconsin
ZIP/Postal Code
53227
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20018493
Citation
Tauscher J, Kielbasa W, Iyengar S, Vandenhende F, Peng X, Mozley D, Gehlert DR, Marek G. Development of the 2nd generation neurokinin-1 receptor antagonist LY686017 for social anxiety disorder. Eur Neuropsychopharmacol. 2010 Feb;20(2):80-7. doi: 10.1016/j.euroneuro.2009.10.005. Epub 2009 Dec 16.
Results Reference
derived

Learn more about this trial

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

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