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A Comparison of Duloxetine Hydrochloride, Marketed Comparator, and Placebo in the Treatment of Generalized Anxiety Disorder

Primary Purpose

Anxiety Disorders

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Duloxetine

venlafaxine

placebo

About this trial

This is an interventional treatment trial for Anxiety Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and female outpatients at least 18 years of age, presenting with generalized anxiety disorder (GAD) based on the disease diagnostic criteria. Must suffer from GAD and not from an adjustment disorder or anxiety disorder not otherwise specified. The symptoms of GAD should not be situational in nature. Exclusion Criteria: Any current and primary DSM-IV Axis I diagnosis other than GAD, including: Patients diagnosed with major depressive disorder within the past 6 months; or Patients diagnosed with panic disorder, or post-traumatic stress disorder within the past year; or Patients diagnosed with obsessive-compulsive disorder, bipolar affective disorder, psychosis, factitious disorder, or somatoform disorders during their lifetimes. The presence of an Axis II disorder or history of antisocial behavior, which, in the judgement of the investigator, would interfere with compliance with the study protocol.

Sites / Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Outcomes

Primary Outcome Measures

To assess whether duloxetine hydrochloride 60 to 120 mg once daily is superior to placebo in the treatment of GAD during a 10-week, double-blind acute therapy phase, defined as statistically greater reduction in anxiety symptoms as measured by the HAMA.

Secondary Outcome Measures

Self-reported anxiety symptomatology;Quality of Life;Clinical Global Improvement;HAMA factor scores

Full Information

NCT ID

NCT00122850

First Posted

July 20, 2005

Last Updated

November 5, 2007

Sponsor

Eli Lilly and Company

Collaborators

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT00122850

Brief Title

A Comparison of Duloxetine Hydrochloride, Marketed Comparator, and Placebo in the Treatment of Generalized Anxiety Disorder

Official Title

A Comparison of Duloxetine Hydrochloride, Venlafaxine Extended Release, and Placebo in the Treatment of Generalized Anxiety Disorder.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2007

Overall Recruitment Status

Completed

Study Start Date

October 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

Collaborators

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

This study will examine duloxetine compared with placebo and an active comparator in the treatment of generalized anxiety disorder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

Double

Allocation

Randomized

Enrollment

480 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Duloxetine

Intervention Type

Drug

Intervention Name(s)

venlafaxine

Intervention Type

Drug

Intervention Name(s)

placebo

Primary Outcome Measure Information:

Title

Secondary Outcome Measure Information:

Title

Self-reported anxiety symptomatology;Quality of Life;Clinical Global Improvement;HAMA factor scores

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

City

Birmingham

State/Province

Alabama

Country

United States

Facility Name

City

La Mesa

State/Province

California

Country

United States

Facility Name

City

Denver

State/Province

Colorado

Country

United States

Facility Name

City

Washington

State/Province

District of Columbia

Country

United States

Facility Name

City

Coral Springs

State/Province

Florida

Country

United States

Facility Name

City

Jacksonville

State/Province

Florida

Country

United States

Facility Name

City

Maitland

State/Province

Florida

Country

United States

Facility Name

City

Libertyville

State/Province

Illinois

Country

United States

Facility Name

City

Oakbrook Terrace

State/Province

Illinois

Country

United States

Facility Name

City

Florence

State/Province

Kentucky

Country

United States

Facility Name

City

Baltimore

State/Province

Maryland

Country

United States

Facility Name

City

Belmont

State/Province

Massachusetts

Country

United States

Facility Name

City

Cambridge

State/Province

Massachusetts

Country

United States

Facility Name

City

Clementon

State/Province

New Jersey

Country

United States

Facility Name

City

New York

State/Province

New York

Country

United States

Facility Name

City

Oklahoma City

State/Province

Oklahoma

Country

United States

Facility Name

City

Philadelphia

State/Province

Pennsylvania

Country

United States

Facility Name

City

Richmond

State/Province

Virginia

Country

United States

Facility Name

City

Seattle

State/Province

Washington

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22249355

Citation

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.

Results Reference

derived

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

18635722

Citation

Allgulander C, Nutt D, Detke M, Erickson J, Spann M, Walker D, Ball S, Russell J. A non-inferiority comparison of duloxetine and venlafaxine in the treatment of adult patients with generalized anxiety disorder. J Psychopharmacol. 2008 Jun;22(4):417-25. doi: 10.1177/0269881108091588.

Results Reference

derived

PubMed Identifier

17559726

Citation

Allgulander C, Hartford J, Russell J, Ball S, Erickson J, Raskin J, Rynn M. Pharmacotherapy of generalized anxiety disorder: results of duloxetine treatment from a pooled analysis of three clinical trials. Curr Med Res Opin. 2007 Jun;23(6):1245-52. doi: 10.1185/030079907X182202. Epub 2007 Apr 25.

Results Reference

derived

PubMed Identifier

17474806

Citation

Endicott J, Russell JM, Raskin J, Detke MJ, Erickson J, Ball SG, Marciniak M, Swindle RW. Duloxetine treatment for role functioning improvement in generalized anxiety disorder: three independent studies. J Clin Psychiatry. 2007 Apr;68(4):518-24. doi: 10.4088/jcp.v68n0405. Erratum In: J Clin Psychiatry. 2007 Apr;68(4):518. J Clin Psychiatry. 2007 May;68(5):806.

Results Reference

derived

PubMed Identifier

17414743

Citation

Hartford J, Kornstein S, Liebowitz M, Pigott T, Russell J, Detke M, Walker D, Ball S, Dunayevich E, Dinkel J, Erickson J. Duloxetine as an SNRI treatment for generalized anxiety disorder: results from a placebo and active-controlled trial. Int Clin Psychopharmacol. 2007 May;22(3):167-74. doi: 10.1097/YIC.0b013e32807fb1b2.

Results Reference

derived

Learn more about this trial

A Comparison of Duloxetine Hydrochloride, Marketed Comparator, and Placebo in the Treatment of Generalized Anxiety Disorder

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