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Duloxetine for the Treatment of Generalized Anxiety Disorder

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Duloxetine
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Psychiatric Diagnosis of generalized anxiety disorder (GAD)
  • Outpatients
  • Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis for GAD
  • Clinical Global Impression (CGI) of Severity Score of at least moderate
  • Sheehan Disability Scale (SDS) Global Functioning Impairment Score >= 12

Exclusion Criteria:

  • Pregnancy or breast feeding
  • Serious medical illness
  • Other primary psychiatric diagnoses, such as major depressive disorder or substance abuse disorder within the past 6 months
  • panic disorder, post-traumatic stress disorder (PTSD), or eating disorder in the last year
  • lifetime history of bipolar or psychosis
  • Any unstable serious medical condition for which duloxetine would not be allowed
  • Any use of medications that are not allowed

Sites / Locations

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Duloxetine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'

Secondary Outcome Measures

Change From Baseline in the Hamilton Anxiety (HAMA) Rating Scale Total Score at Endpoint
The HAMA scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56.
Mean Clinical Global Impressions (CGI) Improvement Score at Endpoint
Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).
Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint
BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores
The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual item scores range from 0-10, with higher numbers indicating greater disruption. Item 1 is for work/schoolwork, Item 2 is for social life/leisure activities, Item 3 is for family life/home responsibilities.
Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint
VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0= no pain and 100=very severe pain).
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Endpoint
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'

Full Information

First Posted
December 3, 2008
Last Updated
November 19, 2010
Sponsor
Eli Lilly and Company
Collaborators
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00803361
Brief Title
Duloxetine for the Treatment of Generalized Anxiety Disorder
Official Title
Duloxetine Versus Placebo in the Treatment of Patients With Generalized Anxiety Disorder in China
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company
Collaborators
Boehringer Ingelheim

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a 15 week study comparing how well duloxetine and placebo treatments improve generalized anxiety disorder

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Duloxetine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
Cymbalta, LY248686
Intervention Description
60 to 120 mg, capsules, oral, once a day for 15 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo capsules, oral, once a day for 15 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint
Description
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'
Time Frame
Baseline, Week 15
Secondary Outcome Measure Information:
Title
Change From Baseline in the Hamilton Anxiety (HAMA) Rating Scale Total Score at Endpoint
Description
The HAMA scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56.
Time Frame
Baseline, Week 15
Title
Mean Clinical Global Impressions (CGI) Improvement Score at Endpoint
Description
Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).
Time Frame
Week 15
Title
Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint
Description
BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
Time Frame
Baseline, Week 15
Title
Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores
Description
The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual item scores range from 0-10, with higher numbers indicating greater disruption. Item 1 is for work/schoolwork, Item 2 is for social life/leisure activities, Item 3 is for family life/home responsibilities.
Time Frame
Baseline, Week 15
Title
Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint
Description
VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0= no pain and 100=very severe pain).
Time Frame
Baseline, Week 15
Title
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Endpoint
Description
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'
Time Frame
Baseline, Week 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Psychiatric Diagnosis of generalized anxiety disorder (GAD) Outpatients Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis for GAD Clinical Global Impression (CGI) of Severity Score of at least moderate Sheehan Disability Scale (SDS) Global Functioning Impairment Score >= 12 Exclusion Criteria: Pregnancy or breast feeding Serious medical illness Other primary psychiatric diagnoses, such as major depressive disorder or substance abuse disorder within the past 6 months panic disorder, post-traumatic stress disorder (PTSD), or eating disorder in the last year lifetime history of bipolar or psychosis Any unstable serious medical condition for which duloxetine would not be allowed Any use of medications that are not allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
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, 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
Beijing
ZIP/Postal Code
100088
Country
China
Facility Name
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.
City
Guang Zhou
ZIP/Postal Code
510370
Country
China
Facility Name
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.
City
Hangzhou
ZIP/Postal Code
310009
Country
China
Facility Name
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.
City
Kunming
ZIP/Postal Code
650032
Country
China
Facility Name
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.
City
Nanjing
ZIP/Postal Code
210029
Country
China
Facility Name
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.
City
Shanghai
ZIP/Postal Code
200065
Country
China
Facility Name
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.
City
Xi'An
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
22088518
Citation
Wu WY, Wang G, Ball SG, Desaiah D, Ang QQ. Duloxetine versus placebo in the treatment of patients with generalized anxiety disorder in China. Chin Med J (Engl). 2011 Oct;124(20):3260-8.
Results Reference
derived

Learn more about this trial

Duloxetine for the Treatment of Generalized Anxiety Disorder

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