Duloxetine vs Placebo in the Treatment of General Anxiety
Primary Purpose
Anxiety
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
duloxetine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
Eligibility Criteria
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.
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.
Outcomes
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)
Full Information
NCT ID
NCT00475969
First Posted
May 16, 2007
Last Updated
May 17, 2007
Sponsor
Eli Lilly and Company
Collaborators
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT00475969
Brief Title
Duloxetine vs Placebo in the Treatment of General Anxiety
Official Title
Duloxetine Hydrochloride Once Daily Compared With Placebo in the Treatment of Generalized Anxiety Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (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
To see if duloxetine 60 to 120 mg once daily (QD) is better than placebo in the treatment of generalized anxiety disorder (GAD).
Detailed Description
duloxetine 60 to 120 mg once daily (QD) and placebo 11 weeks
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
327 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
duloxetine
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Hamilton Anxiety Rating Scale (HAMA) total score (Hamilton 1959)
Secondary Outcome Measure Information:
Title
Sheehan Disability Scale (SDS) Global Functional Impairment score (Sheehan 1983)
Title
Hospital Anxiety Depression Scale (HADS; Zigmond and Snaith 1983)
Title
Clinical Global Impressions of Improvement scale (CGI-Improvement; Guy 1976)
Title
Patient's Global Impressions of Improvement scale (PGI-Improvement; Guy 1976)
Title
Symptom Questionnaire-Somatic Subscale (SQ-SS)
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 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.
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
Indianapolis
State/Province
Indiana
Country
United States
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
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
Learn more about this trial
Duloxetine vs Placebo in the Treatment of General Anxiety
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