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

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00122837
First received: July 20, 2005
Last updated: October 17, 2007
Last verified: October 2007
  Purpose

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


Condition Intervention Phase
Anxiety Disorder
Drug: Duloxetine
Drug: venlafaxine
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Comparison of Duloxetine Hydrochloride, Venlafaxine Extended Release, and Placebo in the Treatment of Generalized Anxiety Disorder

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Self-reported anxiety symptomatology
  • Quality of Life
  • Clinical Global Improvement
  • HAMA factor scores

Estimated Enrollment: 560
Study Start Date: April 2005
Study Completion Date: January 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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  • Have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122837

Locations
Argentina
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Buenos Aires, Argentina, 1425
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Cordoba, Argentina, 5009
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Rosario, Argentina, 2000
Australia, Queensland
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Everton Park, Queensland, Australia, 4053
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Spring Hill, Queensland, Australia, 4000
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Toowoomba, Queensland, Australia, 4350
Australia, Victoria
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Armadale, Victoria, Australia, 3143
Belgium
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Liège, Belgium, 4000
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Tielt, Belgium, 8700
Canada, British Columbia
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Kelowna, British Columbia, Canada, V1Y 2H4
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Vancouver, British Columbia, Canada, V6T 2A1
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Ontario
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Ottawa, Ontario, Canada, K1G 4G3
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Toronto, Ontario, Canada, M5G 1N8
Mexico
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Mexico City, Mexico, 06700
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San Luis Potosi, Mexico, 78090
Russian Federation
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Moscow, Russian Federation, 119839
Taiwan
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Changhua, Taiwan, 500
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Taichung, Taiwan, 404
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Taipei, Taiwan, 100
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Tao-Yuan, Taiwan, 333
United Kingdom
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, United Kingdom, G81 2DR
Sponsors and Collaborators
Eli Lilly and Company
Boehringer Ingelheim
Investigators
Study Director: 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
  More Information

Additional Information:
No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00122837     History of Changes
Other Study ID Numbers: 7106, F1J-MC-HMDW
Study First Received: July 20, 2005
Last Updated: October 17, 2007
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Venlafaxine
Duloxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on July 29, 2014