Brief Summary

This is a clinical trial assessing the time to relapse of anxiety symptoms among patients with generalized anxiety disorder who have responded to duloxetine therapy.

Trial Health

On Track

Trial Health Score

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

Enrollment

380

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Jan 2005

Geographic Reach

7 countries

47 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

2.2 years study duration

Study Start

First participant enrolled

January 1, 2005

Completed

7 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2005

Completed

2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed

1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed

Last Updated

August 31, 2007

Status Verified

August 1, 2007

First QC Date

July 20, 2005

Last Update Submit

August 29, 2007

Conditions

Anxiety Disorders

Outcome Measures

Primary Outcomes (1)

Assess the long-term maintenance of efficacy of duloxetine 60 to 120 mg QD compared with placebo by a comparison of the time to relapse among patients with GAD who responded to duloxetine during the open-label acute therapy phase after 22 to 26 weeks.

Secondary Outcomes (5)

Self-reported anxiety symptomatology
Pain
Quality of Life
Clinical Global Improvement and HAMA Factor scores
Maintenance of Effect

Interventions

Duloxetine HydrochlorideDRUG

placeboDRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients presenting with generalized anxiety disorder (GAD) in the absence of major depressive disorder (MDD). Patients 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.

You may not qualify if:

Any current and primary diagnosis other than GAD. Patients diagnosed with or who have a history of 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.
History of alcohol or any psychoactive substance abuse of dependence (as defined in the DSM-IV-TR) within the past 6 months
Serious medical illness, including cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require hospitalization within 6 months, in the opinion of the investigator. Clinically significant laboratory abnormalities are those, that, in the judgement of the investigator, indicate a serious medical problem.
Acute liver injury (such as hepatitis) or severe cirrhosis (Child- Pugh Class C)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead
Boehringer Ingelheimcollaborator

Study Sites (47)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Sherman Oaks, California, United States

Location

Fort Myers, Florida, United States

Location

Atlanta, Georgia, United States

Location

Libertyville, Illinois, United States

Location

Prairie Village, Kansas, United States

Location

Belmont, Massachusetts, United States

Location

Saint Charles, Missouri, United States

Location

New York, New York, United States

Location

Chapel Hill, North Carolina, United States

Location

Allentown, Pennsylvania, United States

Location

Media, Pennsylvania, United States

Location

Lincoln, Rhode Island, United States

Location

Charleston, South Carolina, United States

Location

Lake Jackson, Texas, United States

Location

Wichita Falls, Texas, United States

Location

Woodstock, Vermont, United States

Location

Bellevue, Washington, United States

Location

Seattle, Washington, United States

Location

Milwaukee, Wisconsin, United States

Location

Vienna, Austria

Location

Aix-en-Provence, France

Location

Arcachon, France

Location

Bordeaux, France

Location

Bourg-des-Comptes, France

Location

Caen, France

Location

Cherbourg, France

Location

Clermont-Ferrand, France

Location

Metz, France

Location

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 - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Montigny-lès-Metz, France

Location

Mulhouse, France

Location

Orvault, France

Location

Rennes, France

Location

Berlin, Germany

Location

Dresden, Germany

Location

Göttingen, Germany

Location

Hildesheim, Germany

Location

Leipzig, Germany

Location

München, Germany

Location

Werneck, Germany

Location

Almere Stad, Netherlands

Location

Nijverdal, Netherlands

Location

Rotterdam, Netherlands

Location

Coimbra, Portugal

Location

Lisbon, Portugal

Location

Porto, Portugal

Location

Hato Rey, Puerto Rico

Location

Ponce, Puerto Rico

Location

Related Publications (1)

Perlis RH, Fijal B, Dharia S, Houston JP. Pharmacogenetic investigation of response to duloxetine treatment in generalized anxiety disorder. Pharmacogenomics J. 2013 Jun;13(3):280-5. doi: 10.1038/tpj.2011.62. Epub 2012 Jan 17.
PMID: 22249355DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

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

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

July 20, 2005

First Posted

July 22, 2005

Study Start

January 1, 2005

Study Completion

March 1, 2007

Last Updated

August 31, 2007

Record last verified: 2007-08

Locations

PT(3)AU(1)US(19)DE(7)FR(12)NL(3)PR(2)

Duloxetine Compared With Placebo in the Prevention of Relapse in Generalized Anxiety Disorder

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (47)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (47)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations