Brief Summary

The purpose of this study is to test the safety and efficacy of duloxetine versus placebo in elderly patients suffering from generalized anxiety disorder (GAD).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

291

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Oct 2010

Geographic Reach

9 countries

25 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.8 years study duration

First Submitted

Initial submission to the registry

May 5, 2010

Completed

2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2010

Completed

5 months until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

September 2, 2013

Completed

Last Updated

September 2, 2013

Status Verified

June 1, 2013

Enrollment Period

1.8 years

First QC Date

May 5, 2010

Results QC Date

June 25, 2013

Last Update Submit

June 25, 2013

Conditions

Generalized Anxiety Disorder

Keywords

GADGeneralized Anxiety DisorderAnxiety

Outcome Measures

Primary Outcomes (1)

Change From Baseline to Week 10 in Hamilton Anxiety Rating Scale (HAMA) Total Score
The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity. Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Baseline, Week 10

Secondary Outcomes (19)

Change From Baseline to Week 10 in Sheehan Disability Scale (SDS) Global Functional Impairment Score
Baseline, Week 10
Change From Baseline to Week 10 in Hamilton Anxiety Rating Scale (HAMA) (Psychic Anxiety Factor Score, Somatic Anxiety Factor Score, and Individual Item Scores: Anxious Mood Item and Tension Item)
Baseline, Week 10
Change From Baseline to Week 10 Endpoint in Hospital Anxiety Depression Scale (HADS) Subscale Scores
Baseline, Week 10
Clinical Global Impressions of Improvement Scale (CGI-Improvement) at Week 10
Week 10
Patient's Global Impressions of Improvement Scale (PGI-Improvement) at Week 10
Week 10
+14 more secondary outcomes

Other Outcomes (1)

Number of Participants Experiencing a Treatment-Emergent Adverse Event (AE) During the Taper Period
2 weeks during the taper period

Study Arms (2)

Duloxetine 30 milligrams (mg) -120 mg

EXPERIMENTAL

Drug: Duloxetine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

DuloxetineDRUG

Administered by mouth, daily for 10 weeks

Also known as: Cymbalta, Duloxetine Hydrochloride, LY248686

Duloxetine 30 milligrams (mg) -120 mg

PlaceboDRUG

Administered by mouth, daily for 10 weeks

Placebo

Eligibility Criteria

Age65 Years+

Sexall

Healthy VolunteersNo

Age GroupsOlder Adult (65+)

You may qualify if:

Have GAD based on diagnostic criteria and not suffer from an adjustment disorder or anxiety disorder not otherwise specified. Symptoms of GAD should not be situational in nature.
Have a Mini Mental State Examination (MMSE) score of at least 24 at screening.
Have a Clinical Global Impressions of Severity (CGI-Severity) score of greater than or equal to 4 at screening and randomization.
Have a Covi Anxiety Scale (CAS) score of greater than or equal to 9, no item in the Raskin Depression Scale (RDS) may be \>3, and the CAS score must be greater than the RDS at screening.
Have a Hospital Anxiety and Depression Scale (HADS) anxiety subscale score of greater than or equal to 10 at screening.
Have a degree of understanding such that the participant can communicate intelligibly with the investigator and study coordinator.
Are judged to be reliable to keep all appointments and able to swallow all required medication without opening or crushing.

You may not qualify if:

Have any current and primary Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revised (DSM-IV TR) Axis I diagnosis other than GAD, with the exception of comorbid social phobia or specific phobia.
major depressive disorder (MDD) within the past 6 months, or
panic disorder, posttraumatic stress disorder (PTSD), or an eating disorder within the past year, or
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, or participants who, in the opinion of the investigator, are poor medical or psychiatric risks for study compliance.
Have organic mental disorder or mental retardation diagnosis.
Use of benzodiazepine within 14 days prior to randomization.
Are judged clinically to be at serious risk of harm to self or others.
Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine within the past year or participants with a lack of response or intolerability to duloxetine (for any approved indication) at a clinically appropriate dose for a minimum of 4 weeks.
Have a history of alcohol or any psychoactive substance abuse or dependence within the past 6 months.
Excessively use caffeine, in the opinion of the investigator.
Have a positive urine drug screen (UDS) for any substances of abuse at screening.
Have a serious medical illness.
Have any acute liver injury or severe cirrhosis.
+8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (25)

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.

Orlando, Florida, 32806, United States

Location

Prairie Village, Kansas, 66206, United States

Location

Baltimore, Maryland, 21208, United States

Location

Nashua, New Hampshire, 03060, United States

Location

Toms River, New Jersey, 08755, United States

Location

Staten Island, New York, 10312, United States

Location

Cincinnati, Ohio, 45219, United States

Location

Philadelphia, Pennsylvania, 19139, United States

Location

Clinton, Utah, 84015, United States

Location

Bellevue, Washington, 98007, United States

Location

Buenos Aires, 1900, Argentina

Location

Rosario, 2000, Argentina

Location

Santiago del Estero, 4200, Argentina

Location

Vienna, A-1090, Austria

Location

Sydney, Nova Scotia, B1P 1E1, Canada

Location

Chatham, Ontario, N7M 5L9, Canada

Location

Berlin, 12209, Germany

Location

Hattingen, D-45525, Germany

Location

Aguascalientes, 20217, Mexico

Location

Monterrey, 64000, Mexico

Location

Chełmno, 86-200, Poland

Location

Tuszyn, 95-080, Poland

Location

Bayamón, 00961, Puerto Rico

Location

Ponce, 00731, Puerto Rico

Location

Chesterfield, Chesterfield, S40 4TF, United Kingdom

Location

MeSH Terms

Conditions

Generalized Anxiety DisorderAnxiety Disorders

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 5, 2010

First Posted

May 7, 2010

Study Start

October 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

September 2, 2013

Results First Posted

September 2, 2013

Record last verified: 2013-06

Locations

GB(1)PL(2)ME(2)AU(1)AR(3)CA(2)US(10)DE(2)PR(2)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (19)

Other Outcomes (1)

Study Arms (2)

Duloxetine 30 milligrams (mg) -120 mg

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (25)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations