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

This study has been terminated.
(Change of MRI mode)
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00491348
First received: June 23, 2007
Last updated: December 21, 2008
Last verified: December 2008

June 23, 2007
December 21, 2008
April 2007
November 2008   (final data collection date for primary outcome measure)
difference of brain activation on worry [ Time Frame: two months ] [ Designated as safety issue: No ]
difference of brain activation on worry [ Time Frame: two months ]
Complete list of historical versions of study NCT00491348 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effects of Duloxetine on Pathological Worry in Patients With Generalized Anxiety Disorder: A fMRI Study
Effects of Duloxetine on Pathological Worry in Patients With Generalized Anxiety Disorder: A fMRI Study

(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

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Worry
  • Anxiety
Drug: duloxetine hydrochloride
duloxetine 30 mg QD, may titrate to 30 mg BID, and maintain the dosage for 6 weeks
Other Name: Cymbalta
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
23
November 2008
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00491348
950508
Yes
Mei-Chih Tseng/Attending psychiatrist, National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Study Director: Mei-Chih Tseng, MD NTUH
National Taiwan University Hospital
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP