Effects of Duloxetine on Pathological Worry in Patients With Generalized Anxiety Disorder: A fMRI Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00491348
Recruitment Status : Terminated (Change of MRI mode)
First Posted : June 26, 2007
Last Update Posted : December 23, 2008
Information provided by:
National Taiwan University Hospital

Brief Summary:
(1) to compare the differences of neural activation of pathological worry between pre-treatment GAD patients and normal subjects; (2) to measure the differences of brain activation on worry in GAD patients before and after duloxetine treatment

Condition or disease Intervention/treatment Phase
Worry Anxiety Drug: duloxetine hydrochloride Not Applicable

Detailed Description:

The study will recruit 20 GAD patients and 20 healthy controls. Both patients and controls receive a medical and psychiatric screening procedure at visit 1 and are asked to complete three self-rating questionnaires and one health questionnaire at visit 1. All qualified participants will receive functional magnetic resonance imaging (fMRI) at baseline.

The patients will begin treatment with duloxetine 30 mg/day at visit 2 and will be titrated to 60 mg/day at visit 3 (2 week since drug dispensed). The dosage will be maintained on 60 mg/day for 6 more weeks. During the period, the patients will receive periodic evaluations at visit 2 (0 week drug dispensed), 3 (2 week since drug dispensed), 4 (4 weeks since drug dispensed), and 5 (8 weeks since drug dispensed). The patients will receive fMRI examination at baseline and at the end of the 8-week treatment.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Duloxetine on Pathological Worry in Patients With Generalized Anxiety Disorder: A fMRI Study
Study Start Date : April 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Intervention Details:
    Drug: duloxetine hydrochloride
    duloxetine 30 mg QD, may titrate to 30 mg BID, and maintain the dosage for 6 weeks
    Other Name: Cymbalta

Primary Outcome Measures :
  1. difference of brain activation on worry [ Time Frame: two months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • DSM-IV criteria of generalized anxiety disorders with moderate degree
  • Participants above 18 years old

Exclusion Criteria:

  • Major depression
  • Panic disorder
  • Obsessive-compulsive disorder
  • Post-traumatic disorder
  • Eating disorders
  • Psychotic disorders; and
  • Alcohol or other substance use disorders
  • Neurological disease
  • Cardio-vascular disease
  • Respiratory disease
  • Head trauma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00491348

National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Study Director: Mei-Chih Tseng, MD NTUH

Responsible Party: Mei-Chih Tseng/Attending psychiatrist, National Taiwan University Hospital Identifier: NCT00491348     History of Changes
Other Study ID Numbers: 950508
First Posted: June 26, 2007    Key Record Dates
Last Update Posted: December 23, 2008
Last Verified: December 2008

Keywords provided by National Taiwan University Hospital:
Generalized anxiety disorder

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents