Back to resultsDuloxetine Compared With Placebo in Patients With Generalized Anxiety Disorder
Primary Purpose
Anxiety Disorders
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
duloxetine hydrochloride
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorders
Eligibility Criteria
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Criteria: Male and female outpatients at least 18 years of age Exclusion Criteria: Have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine Patient diagnosed with major depressive disorder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
Sites / Locations
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Outcomes
Primary Outcome Measures
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 Outcome Measures
Self-reported anxiety symptomatology;Pain;Quality of Life;Clinical Global Improvement;HAMA factor scores
Full Information
NCT ID
NCT00122824
First Posted
July 20, 2005
Last Updated
November 5, 2007
Sponsor
Eli Lilly and Company
Collaborators
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT00122824
Brief Title
Duloxetine Compared With Placebo in Patients With Generalized Anxiety Disorder
Official Title
Duloxetine Hydrochloride 60 mg or 120 mg Once Daily Compared With Placebo in Patients With Generalized Anxiety Disorder.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
Collaborators
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
This is a clinical trial assessing duloxetine compared with placebo in patients who have generalized anxiety disorder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
480 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
duloxetine hydrochloride
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Self-reported anxiety symptomatology;Pain;Quality of Life;Clinical Global Improvement;HAMA factor scores
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-285-4559 or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
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.
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
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.
City
Bourg-en-Bresse
ZIP/Postal Code
01000
Country
France
Facility Name
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.
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
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.
City
Paarl
ZIP/Postal Code
7646
Country
South Africa
Facility Name
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.
City
Barcelona
ZIP/Postal Code
08013
Country
Spain
Facility Name
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.
City
Uppsala
ZIP/Postal Code
75324
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
21102344
Citation
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.
Results Reference
derived
PubMed Identifier
18662492
Citation
Sheehan DV, Meyers AL, Prakash A, Robinson MJ, Swindle RW, Russell JM, Mallinckrodt CH. The relationship between functional outcomes and the treatment of anxious and painful somatic symptoms in patients with generalized anxiety disorder. Curr Med Res Opin. 2008 Sep;24(9):2457-66. doi: 10.1185/03007990802293643. Epub 2008 Jul 24.
Results Reference
derived
PubMed Identifier
18615176
Citation
Hartford JT, Endicott J, Kornstein SG, Allgulander C, Wohlreich MM, Russell JM, Perahia DG, Erickson JS. Implications of pain in generalized anxiety disorder: efficacy of duloxetine. Prim Care Companion J Clin Psychiatry. 2008;10(3):197-204. doi: 10.4088/pcc.v10n0304.
Results Reference
derived
PubMed Identifier
17607331
Citation
Koponen H, Allgulander C, Erickson J, Dunayevich E, Pritchett Y, Detke MJ, Ball SG, Russell JM. Efficacy of duloxetine for the treatment of generalized anxiety disorder: implications for primary care physicians. Prim Care Companion J Clin Psychiatry. 2007;9(2):100-7. doi: 10.4088/pcc.v09n0203.
Results Reference
derived
PubMed Identifier
17559726
Citation
Allgulander C, Hartford J, Russell J, Ball S, Erickson J, Raskin J, Rynn M. Pharmacotherapy of generalized anxiety disorder: results of duloxetine treatment from a pooled analysis of three clinical trials. Curr Med Res Opin. 2007 Jun;23(6):1245-52. doi: 10.1185/030079907X182202. Epub 2007 Apr 25.
Results Reference
derived
PubMed Identifier
17474806
Citation
Endicott J, Russell JM, Raskin J, Detke MJ, Erickson J, Ball SG, Marciniak M, Swindle RW. Duloxetine treatment for role functioning improvement in generalized anxiety disorder: three independent studies. J Clin Psychiatry. 2007 Apr;68(4):518-24. doi: 10.4088/jcp.v68n0405. Erratum In: J Clin Psychiatry. 2007 Apr;68(4):518. J Clin Psychiatry. 2007 May;68(5):806.
Results Reference
derived
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Duloxetine Compared With Placebo in Patients With Generalized Anxiety Disorder
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