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Duloxetine vs Placebo in the Treatment of General Anxiety

This study has been completed.
Boehringer Ingelheim
Information provided by:
Eli Lilly and Company Identifier:
First received: May 16, 2007
Last updated: May 17, 2007
Last verified: May 2007
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
Drug: duloxetine
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Duloxetine Hydrochloride Once Daily Compared With Placebo in the Treatment of Generalized Anxiety Disorder

Resource links provided by NLM:

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Hamilton Anxiety Rating Scale (HAMA) total score (Hamilton 1959)

Secondary Outcome Measures:
  • Sheehan Disability Scale (SDS) Global Functional Impairment score (Sheehan 1983)
  • Hospital Anxiety Depression Scale (HADS; Zigmond and Snaith 1983)
  • Clinical Global Impressions of Improvement scale (CGI-Improvement; Guy 1976)
  • Patient's Global Impressions of Improvement scale (PGI-Improvement; Guy 1976)
  • Symptom Questionnaire-Somatic Subscale (SQ-SS)

Estimated Enrollment: 327
Study Start Date: August 2004
Study Completion Date: June 2005
Detailed Description:
duloxetine 60 to 120 mg once daily (QD) and placebo 11 weeks

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and female outpatients at least 18 years of age presenting with generalized anxiety disorder (GAD) based on the disease diagnostic criteria The patient must suffer from GAD and not from an adjustment disorder or anxiety disorder not otherwise specified (NOS). Symptoms of GAD should not be situational in nature.
  • Females of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopause) who are not breastfeeding; test negative for pregnancy at the time of enrollment based on a urine pregnancy test; and agree to use a reliable method of birth control during the study and for 1 week following the last dose of study drug.
  • Must have a Clinical Global Impressions of Severity (CGI-Severity) score of greater than or equal to 4 at Visit 1 and Visit 2.
  • At Visit 1, patient must have a Covi Anxiety Scale (CAS) score of greater than or equal to 9, no item in the Raskin Depression Scale (RDS) may be greater than 3, and the CAS must be greater than the RDS.
  • Must have a Hospital Anxiety and Depression Scale (HADS) anxiety subscale score of greater than or equal to 10 at Visit 1.

Exclusion Criteria:

  • Any current and primary DSM-IV Axis I diagnosis other than GAD.

    • Patients diagnosed with or who have a history of major depressive disorder (MDD) within the past 6 months or
    • Patients diagnosed with or who have a history of Panic Disorder, Post-Traumatic Stress Disorder (PTSD), or an eating disorder within the past year or
    • Patients who have been diagnosed with Obsessive Compulsive Disorder (OCD), Bipolar Affective Disorder, psychosis, factitious disorder, or somatoform disorders during their lifetime.
  • The presence of an Axis II disorder or history of antisocial behavior, which, in the judgment of the investigator, would interfere with compliance with the study protocol.
  • Benzodiazepine use 14 days prior to Visit 2.
  • Patients judged clinically to be at serious suicidal risk, or patients who, in the opinion of the investigator, are poor medical or psychiatric risks for study completion.
  • Have received treatment within the last 30 days with a drug (not including study drug) that has not received regulatory approval for any indication at the time of study entry.
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Please refer to this study by its identifier: NCT00475969

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
Sponsors and Collaborators
Eli Lilly and Company
Boehringer Ingelheim
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
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00475969     History of Changes
Other Study ID Numbers: 6089
Study First Received: May 16, 2007
Last Updated: May 17, 2007

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents processed this record on April 28, 2017