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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
National Taiwan University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Worry focused on measuring Generalized anxiety disorder, fMRI, Worry

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
June 23, 2007
Last Updated
December 21, 2008
Sponsor
National Taiwan University Hospital
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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

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

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