Duloxetine vs Placebo in the Treatment of General Anxiety

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00475969
First received: May 16, 2007
Last updated: May 17, 2007
Last verified: May 2007

May 16, 2007
May 17, 2007
August 2004
Not Provided
Hamilton Anxiety Rating Scale (HAMA) total score (Hamilton 1959)
Same as current
Complete list of historical versions of study NCT00475969 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Duloxetine vs Placebo in the Treatment of General Anxiety
Duloxetine Hydrochloride Once Daily Compared With Placebo in the Treatment of Generalized Anxiety Disorder

To see if duloxetine 60 to 120 mg once daily (QD) is better than placebo in the treatment of generalized anxiety disorder (GAD).

duloxetine 60 to 120 mg once daily (QD) and placebo 11 weeks

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Anxiety
  • Drug: duloxetine
  • Drug: placebo
Not Provided
Sheehan DV, Harnett-Sheehan K, Spann ME, Thompson HF, Prakash A. Assessing remission in major depressive disorder and generalized anxiety disorder clinical trials with the discan metric of the Sheehan disability scale. Int Clin Psychopharmacol. 2011 Mar;26(2):75-83. doi: 10.1097/YIC.0b013e328341bb5f. PubMed PMID: 21102344.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
327
June 2005
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00475969
6089, F1J-MC-HMDT
No
Not Provided
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
Eli Lilly and Company
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP