Expired Study
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Libertyville, Illinois


Purpose:

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.


Criteria:

Inclusion Criteria: - 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. Exclusion Criteria: - 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)


Study is Available At:


Original ID:

7108


NCT ID:

NCT00122863


Secondary ID:

F1J-MC-HMDV


Study Acronym:


Brief Title:

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


Official Title:

Duloxetine 60 to 120 mg Once Daily Compared With Placebo in the Prevention of Relapse in Generalized Anxiety Disorder


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Eli Lilly and Company


Oversight Authority:

  • United States: Food and Drug Administration
  • United Kingdom: Medicines and Healthcare Products Regulatory Agency


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

380


Enrollment Type:


Overall Contact Information

Official Name: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)
Study Director
Eli Lilly and Company

Study Dates

Start Date:January 2005
Completion Date:March 2007
Completion Type:Actual
Verification Date:August 2007
Last Changed Date:August 29, 2007
First Received Date:July 20, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Maintenance of Effect
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Clinical Global Improvement and HAMA Factor scores
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Quality of Life
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Pain
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Self-reported anxiety symptomatology
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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.
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Duloxetine Hydrochloride
Intervention Type:Drug
Name:placebo

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Eli Lilly and Company
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Boehringer Ingelheim Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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