Duloxetine for the Treatment of Generalized Anxiety Disorder | NCT00803361

ID	Type	Description	Link
F1J-MC-HMFJ	Other Identifier	Eli Lilly and Company

Name	Class
Boehringer Ingelheim	INDUSTRY

Duloxetine for the Treatment of Generalized Anxiety Disorder | NCT00803361 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
Duloxetine	Experimental		Drug: Duloxetine
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Duloxetine	Drug	60 to 120 mg, capsules, oral, once a day for 15 weeks	Duloxetine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.'	Baseline, Week 15

Secondary Outcomes

Measure	Description	Time Frame
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.	Baseline, Week 15

Contacts/Locations Module

Name	Affiliation	Role
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	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
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.		Beijing		100088

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22088518	Derived	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.

ID	Title	Description
FG000	Duloxetine	60 to 120 mg, capsules, oral, once a day for 15 weeks
FG001	Placebo	placebo capsules, oral, once a day for 15 weeks

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG000108 subjects FG001102 subjects
COMPLETED		FG00082 subjects FG00174 subjects
NOT COMPLETED		FG00026 subjects FG00128 subjects

Type	Comment	Reasons
Adverse Event		FG00013 subjects FG0013 subjects
Lack of Efficacy		FG0004 subjects FG001

Baseline Characteristics Module

ID	Title	Description
BG000	Duloxetine	60 to 120 mg, capsules, oral, once a day for 15 weeks
BG001	Placebo	placebo capsules, oral, once a day for 15 weeks

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.'

Participants with a baseline and at least one post-baseline result within each treatment group.

Posted

Mean

Standard Deviation

Units on a scale

Baseline, Week 15

ID	Title	Description
OG000	Duloxetine	60 to 120 mg, capsules, oral, once a day for 15 weeks
OG001	Placebo

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Duloxetine	60 to 120 mg, capsules, oral, once a day for 15 weeks

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Suicide attempt	Psychiatric disorders	MedDRA 12.0	Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Palpitations	Cardiac disorders	MedDRA 12.0	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Chief Medical Officer	Eli Lilly and Company	800-545-5979

ID	Term
D000098647	Generalized Anxiety Disorder
D001008	Anxiety Disorders

ID	Term
D001523	Mental Disorders

Intervention Browse Module

ID	Term
D000068736	Duloxetine Hydrochloride

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006573	Heterocyclic Compounds, 1-Ring

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG0020
Asian	BG000108 BG001102 BG002210
Native Hawaiian or Other Pacific Islander	BG0000 BG0010 BG0020
Black or African American	BG0000 BG0010 BG0020
White	BG0000 BG0010 BG0020
More than one race	BG0000 BG0010 BG0020
Unknown or Not Reported	BG0000 BG0010 BG0020

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA	Change = Treatment + Pooled Investigator + Baseline	0.006	p-value is for Change from Baseline.	Mean Difference (Final Values)	-1.62			2-Sided	95	-2.76	-0.48				No	Superiority or Other

Secondary

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.

Participants with a baseline and at least one post-baseline result within each treatment group.

Posted

Mean

Standard Deviation

Units on a scale

Baseline, Week 15

ID	Title	Description
OG000	Duloxetine	60 to 120 mg, capsules, oral, once a day for 15 weeks
OG001	Placebo	placebo capsules, oral, once a day for 15 weeks

Units	Counts
Participants	OG000107 OG001100

Title

Denominators

Categories

Baseline

Title	Measurements
	OG00024.50± 5.81 OG00124.24± 5.16

Change from Baseline

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA	Change = Treatment + Pooled Investigator + Baseline	0.024	p-value is for Change from Baseline	Mean Difference (Final Values)	-2.56			2-Sided	95	-4.78	-0.34				No	Superiority or Other

Secondary

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).

Participants with at least one post-baseline result within each treatment group.

Posted

Mean

Standard Deviation

Units on a Scale

Week 15

ID	Title	Description
OG000	Duloxetine	60 to 120 mg, capsules, oral, once a day for 15 weeks
OG001	Placebo	placebo capsules, oral, once a day for 15 weeks

Units	Counts
Participants	OG000107 OG001100

Title

Denominators

Categories

Title	Measurements
	OG0002.08± 0.97 OG0012.54± 1.20

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANOVA		0.004		Mean Difference (Final Values)	-0.44			2-Sided	95	-0.74	-0.15				No	Superiority or Other

Secondary

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.

Participants with a baseline and at least one post-baseline result within each treatment group.

Posted

Mean

Standard Deviation

Units on a Scale

Baseline, Week 15

ID	Title	Description
OG000	Duloxetine	60 to 120 mg, capsules, oral, once a day for 15 weeks
OG001	Placebo	placebo capsules, oral, once a day for 15 weeks

Units	Counts
Participants	OG000107 OG001100

Title

Denominators

Categories

Severity of Worst Pain Baseline

Title	Measurements
	OG0003.39± 2.84 OG0014.22± 3.03

Severity of Worst Pain Change

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA	Change = Treatment + Pooled Investigator + Baseline	0.125	p-value is for Severity of Worst Pain Change.	Mean Difference (Final Values)	-0.41			2-Sided	95	-0.93	0.11				No	Superiority or Other
OG000 OG001

Secondary

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.

Participants with a baseline and at least one post-baseline value.

Posted

Mean

Standard Deviation

Units on a scale

Baseline, Week 15

ID	Title	Description
OG000	Duloxetine	60 to 120 mg, capsules, oral, once a day for 15 weeks
OG001	Placebo	placebo capsules, oral, once a day for 15 weeks

Units	Counts
Participants	OG000107 OG001100

Title

Denominators

Categories

Symptoms Disrupted Work- Baseline (N=101,N=94)

Title	Measurements
	OG0005.94± 2.01 OG0015.85± 1.72

Symptoms Disrupted Work- Change(N=101,N=94)

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA	Change = Treatment + Pooled Investigator + Baseline	0.076	p-value is for symptoms have disrupted your work/schoolwork - change.	Mean Difference (Final Values)	-0.61			2-Sided	95	-1.29	0.06				No	Superiority or Other
OG000 OG001

Secondary

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).

Participants with a baseline and at least one post-baseline result within each treatment group.

Posted

Mean

Standard Deviation

Units on a Scale

Baseline, Week 15

ID	Title	Description
OG000	Duloxetine	60 to 120 mg, capsules, oral, once a day for 15 weeks
OG001	Placebo	placebo capsules, oral, once a day for 15 weeks

Units	Counts
Participants	OG00095 OG00188

Title

Denominators

Categories

Severity of Overall Pain, Past Week, Baseline

Title	Measurements
	OG00027.56± 26.05 OG00131.94± 27.62

Severity of Overall Pain, Past Week, Change

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA	Model: Change = Treatment + Pooled Investigator + Baseline	0.063	p-value is for Severity of Overall Pain, Past Week, Change	Mean Difference (Final Values)	-5.32			2-Sided	95	-10.93	0.30				No	Superiority or Other
OG000 OG001

Secondary

Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Endpoint

Participants with a baseline and at least one post-baseline result within each treatment group.

Posted

Mean

Standard Deviation

Units on a Scale

Baseline, Week 15

ID	Title	Description
OG000	Duloxetine	60 to 120 mg, capsules, oral, once a day for 15 weeks
OG001	Placebo	placebo capsules, oral, once a day for 15 weeks

Units	Counts
Participants	OG000107 OG001100

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0006.90± 3.49 OG0016.62± 3.35

Change from Baseline

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA	Change = Treatment + Pooled Investigator + Baseline	0.068	p-value is for Change from Baseline	Mean Difference (Final Values)	-0.83			2-Sided	95	-1.72	0.06				No	Superiority or Other