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Sponsors and Collaborators: |
Eli Lilly and Company Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00475969 |
To see if duloxetine 60 to 120 mg once daily (QD) is better than placebo in the treatment of generalized anxiety disorder (GAD).
Condition | Intervention | Phase |
---|---|---|
Anxiety |
Drug: duloxetine Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Duloxetine Hydrochloride Once Daily Compared With Placebo in the Treatment of Generalized Anxiety Disorder |
Estimated Enrollment: | 327 |
Study Start Date: | August 2004 |
Study Completion Date: | June 2005 |
duloxetine 60 to 120 mg once daily (QD) and placebo 11 weeks
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Any current and primary DSM-IV Axis I diagnosis other than GAD.
United States, Indiana | |
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. | |
Indianapolis, Indiana, United States |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Study ID Numbers: | 6089, F1J-MC-HMDT |
Study First Received: | May 16, 2007 |
Last Updated: | May 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00475969 |
Health Authority: | United States: Food and Drug Administration |
Dopamine Anxiety Disorders Serotonin Duloxetine |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Physiological Effects of Drugs Psychotropic Drugs |
Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents Antidepressive Agents |