NCT00122837

Brief Summary

This is a clinical trial assessing duloxetine and comparator to placebo in patients who have generalized anxiety disorder.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
560

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2005

Geographic Reach
8 countries

22 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

Study Start

First participant enrolled

April 1, 2005

Completed
4 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
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

October 18, 2007

Status Verified

October 1, 2007

First QC Date

July 20, 2005

Last Update Submit

October 17, 2007

Conditions

Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

  • Assess whether duloxetine hydrochloride 60 to 120 mg QD is superior to placebo in the treatment of GAD, defined as statistically greater reduction in anxiety symptoms as measured by the HAMA

Secondary Outcomes (4)

  • Self-reported anxiety symptomatology

  • Quality of Life

  • Clinical Global Improvement

  • HAMA factor scores

Interventions

DuloxetineDRUG
venlafaxineDRUG
placeboDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female outpatients at least 18 years of age, presenting with generalized anxiety disorder (GAD).

You may not qualify if:

  • Any current and primary Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Axis I diagnosis other than GAD. Patients diagnosed with major depressive disorder within the past 6 months -or- patients diagnosed with panic disorder, post-traumatic stress disorder, or an eating disorder within the past year -or- obsessive-compulsive disorder, bipolar affective disorder, psychosis factitious disorder, or somatoform disorders during their lifetime
  • The presence of an Axis II disorder or history of antisocial behavior, which in the judgement of the investigator would interfere with compliance with study protocol
  • Have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine
  • History of alcohol or any psychoactive substance abuse or dependence (as defined in the DSM-IV-TR) within the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

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. test

Buenos Aires, 1425, Argentina

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

Córdoba, 5009, Argentina

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

Rosario, 2000, Argentina

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

Everton Park, Queensland, 4053, Australia

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

Spring Hill, Queensland, 4000, Australia

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

Toowoomba, Queensland, 4350, Australia

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

Armadale, Victoria, 3143, Australia

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

Liège, 4000, Belgium

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

Tielt, 8700, Belgium

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

Kelowna, British Columbia, V1Y 2H4, Canada

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

Vancouver, British Columbia, V6T 2A1, Canada

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

Winnipeg, Manitoba, R2H 2A6, Canada

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

Ottawa, Ontario, K1G 4G3, Canada

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

Toronto, Ontario, M5G 1N8, Canada

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

Mexico City, 06700, Mexico

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

San Luis Potosí City, 78090, Mexico

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

Moscow, 119839, Russia

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

Changhua, 500, Taiwan

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

Taichung, 404, Taiwan

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

Taipei, 100, Taiwan

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

Taoyuan District, 333, Taiwan

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

Glasgow, Scotland, G81 2DR, United Kingdom

Location

Related Publications (3)

  • 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

  • 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.

    PMID: 21102344DERIVED

  • 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.

    PMID: 18635722DERIVED

Related Links

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Duloxetine HydrochlorideVenlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCyclohexanolsHexanolsFatty AlcoholsAlcoholsPhenethylaminesEthylaminesAminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsLipids

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9am-5pm 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

April 1, 2005

Study Completion

January 1, 2007

Last Updated

October 18, 2007

Record last verified: 2007-10

Locations

TW(4)GB(1)AU(4)CA(5)AR(3)ME(2)BE(2)RU(1)