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OpenTrials
Completed

NCT Number: NCT00122824

Duloxetine Compared With Placebo in Patients With Generalized Anxiety Disorder

This is a clinical trial assessing duloxetine compared with placebo in patients who have generalized anxiety disorder.

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Key information

Conditions

Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559) or 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., Oulu, Finland

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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 and female outpatients at least 18 years of age

Exclusion criteria

  • Have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine
  • Patient diagnosed with major depressive disorder within the past 6 months
  • Patient diagnosed with panic disorder, post-traumatic stress disorder, or an eating disorder within the past year
  • History of alcohol or any psychoactive substance abuse or dependence within the past 6 months

Treatment and study plan

duloxetine hydrochloride

Drug

Placebo

Drug

Primary outcomes

  1. To assess duloxetine 120 mg once daily is superior to placebo in the treatment of GAD, defined as statistically greater reduction on the mean change anxiety symptoms as measured by the HAMA total score.

Secondary outcomes

  1. Self-reported anxiety symptomatology;Pain;Quality of Life;Clinical Global Improvement;HAMA factor scores

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Boehringer Ingelheim

Registry information

Official study title

Duloxetine Hydrochloride 60 mg or 120 mg Once Daily Compared With Placebo in Patients With Generalized Anxiety Disorder.

Important dates

Study start
2004
Study completion
2005
First posted
Jul 22, 2005
Registry last updated
Nov 6, 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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