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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00491348
• Other study ID #: 950508
• Status: Terminated
• Phase: N/A
• First received: June 23, 2007
• Last updated: December 21, 2008
• Start date: April 2007
• Est. completion date: November 2008

Study information

• Verified date: December 2008
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Worry

Intervention

Drug:
• duloxetine hydrochloride
duloxetine 30 mg QD, may titrate to 30 mg BID, and maintain the dosage for 6 weeks

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference of brain activation on worry		two months	No