NCT00191022

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2004

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

February 13, 2007

Status Verified

February 1, 2007

First QC Date

September 12, 2005

Last Update Submit

February 12, 2007

Conditions

Social Phobia

Outcome Measures

Primary Outcomes (1)

  • 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 (10)

  • 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

  • +5 more secondary outcomes

Interventions

LY686017DRUG
paroxetineDRUG
placeboDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

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

Burbank, California, 91506, United States

Location

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

Newport Beach, California, 92660, United States

Location

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

Denver, Colorado, 80212, United States

Location

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

New Britain, Connecticut, 06052, United States

Location

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

Gainesville, Florida, 32611, United States

Location

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

Indianapolis, Indiana, 46202, United States

Location

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

Baltimore, Maryland, 21208, United States

Location

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

Belmont, Massachusetts, 02478, United States

Location

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

New York, New York, 10024, United States

Location

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

Portland, Oregon, 97210, United States

Location

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

Media, Pennsylvania, 19063, United States

Location

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

Houston, Texas, 77074, United States

Location

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

Herndon, Virginia, 20170, United States

Location

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

Richmond, Virginia, 23230, United States

Location

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, 53227, United States

Location

Related Publications (1)

  • 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.

    PMID: 20018493DERIVED

MeSH Terms

Conditions

Phobia, Social

Interventions

LY686017Paroxetine

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM to 5PM EST (UTC/GMT - 5 hours EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

December 1, 2004

Study Completion

January 1, 2007

Last Updated

February 13, 2007

Record last verified: 2007-02

Locations

US(15)