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Completed

NCT Number: NCT00191022

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

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

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Key information

Conditions

Social Phobia Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary 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, Burbank, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY686017

Drug

paroxetine

Drug

Placebo

Drug

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

  1. To compare the safety and tolerability of LY686017 with placebo during 12-week treatment.

  2. 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:

  3. The Liebowitz Social Anxiety subscale scores

  4. The Clinical Global Impression-Improvement scale

  5. The Hamilton Anxiety Scale total score and

  6. The Clinical Global Impression-Severity scale

  7. To assess the efficacy of LY686017 compared with placebo on health outcomes as measured by the Sheehan Disability scale.

  8. To investigate the population pharmacokinetics of LY686017 following multiple administrations of LY686017.

  9. To ascertain whether another approved marketed drug for

  10. social anxiety disorder is statistically significantly more efficacious than placebo in this study.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Randomized, Double-Blind Comparison of LY686017, Paroxetine, and Placebo in the Treatment of Social Anxiety Disorder

Important dates

Study start
2004
Study completion
2007
First posted
Sep 19, 2005
Registry last updated
Feb 13, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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