Effects of Duloxetine on Pathological Worry in Patients With Generalized Anxiety Disorder: A fMRI Study
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Purpose
(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
| Condition | Intervention |
|---|---|
|
Worry Anxiety |
Drug: duloxetine hydrochloride |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Effects of Duloxetine on Pathological Worry in Patients With Generalized Anxiety Disorder: A fMRI Study |
- difference of brain activation on worry [ Time Frame: two months ] [ Designated as safety issue: No ]
| Enrollment: | 23 |
| Study Start Date: | April 2007 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
-
Drug: duloxetine hydrochloride
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Mei-Chih Tseng/Attending psychiatrist, National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT00491348 History of Changes |
| Other Study ID Numbers: | 950508 |
| Study First Received: | June 23, 2007 |
| Last Updated: | December 21, 2008 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by National Taiwan University Hospital:
|
Generalized anxiety disorder fMRI Worry |
Additional relevant MeSH terms:
|
Anxiety Disorders Mental Disorders Duloxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents |
Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Dopamine Uptake Inhibitors Dopamine Agents Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013