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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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00491348
Enrollment
23
Registered
2007-06-26
Start date
2007-04-30
Completion date
2008-11-30
Last updated
2008-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Worry

Keywords

Generalized anxiety disorder, fMRI, Worry

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.

Interventions

DRUGduloxetine hydrochloride

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

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
difference of brain activation on worrytwo months

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026