Effects of Duloxetine on Pathological Worry in Patients With Generalized Anxiety Disorder: A fMRI Study
Primary Purpose
Worry, Anxiety
Status
Terminated
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
duloxetine hydrochloride
Sponsored by
About this trial
This is an interventional basic science trial for Worry focused on measuring Generalized anxiety disorder, fMRI, Worry
Eligibility Criteria
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
Sites / Locations
- National Taiwan University Hospital
Outcomes
Primary Outcome Measures
difference of brain activation on worry
Secondary Outcome Measures
Full Information
NCT ID
NCT00491348
First Posted
June 23, 2007
Last Updated
December 21, 2008
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00491348
Brief Title
Effects of Duloxetine on Pathological Worry in Patients With Generalized Anxiety Disorder: A fMRI Study
Official Title
Effects of Duloxetine on Pathological Worry in Patients With Generalized Anxiety Disorder: A fMRI Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Terminated
Why Stopped
Change of MRI mode
Study Start Date
April 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Worry, Anxiety
Keywords
Generalized anxiety disorder, fMRI, Worry
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
duloxetine hydrochloride
Other Intervention Name(s)
Cymbalta
Intervention Description
duloxetine 30 mg QD, may titrate to 30 mg BID, and maintain the dosage for 6 weeks
Primary Outcome Measure Information:
Title
difference of brain activation on worry
Time Frame
two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mei-Chih Tseng, MD
Organizational Affiliation
NTUH
Official's Role
Study Director
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Effects of Duloxetine on Pathological Worry in Patients With Generalized Anxiety Disorder: A fMRI Study
We'll reach out to this number within 24 hrs