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

Not Applicable

Terminated

• Conditions: Worry; Anxiety

• Registration Number: NCT00491348
• Lead Sponsor: 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

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-06-23
• Study First Submitted QC: 2007-06-25
• Study First Posted: 2007-06-26
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-21
• Last Update Posted: 2008-12-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
difference of brain activation on worry	two months

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan