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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00491348
Other study ID # 950508
Secondary ID
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


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
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