WorryNCT00491348
Effects of Duloxetine on Pathological Worry in Patients With Generalized Anxiety Disorder: A fMRI Study
A study testing duloxetine hydrochloride in people with Worry and Anxiety, run by National Taiwan University Hospital at 1 site in Taiwan.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- duloxetine hydrochloride
- How many people
- 23 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2007to Nov 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- DSM-IV criteria of generalized anxiety disorders with moderate degree
- Participants above 18 years old
Who cannot join
- Major depression
- Panic disorder
- Obsessive-compulsive disorder
- Post-traumatic disorder
- Eating disorders
- Psychotic disorders; and
Show all 11Show fewer
- Alcohol or other substance use disorders
- Neurological disease
- Cardio-vascular disease
- Respiratory disease
- Head trauma
Trial locations and contacts
1 site in 1 country.
About this study
(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
Read the 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.
- Being tested
- duloxetine hydrochloride
- Keywords
- Generalized anxiety disorder, fMRI, Worry
- Medical subject headings
- Anxiety Disorders, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duloxetine hydrochlorideDrug
Also called Cymbalta
duloxetine 30 mg QD, may titrate to 30 mg BID, and maintain the dosage for 6 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
difference of brain activation on worry
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2007 (estimated)
- Study startApr 2007
- Primary completionNov 2008
- Study completionNov 2008
Why it stopped: Change of MRI mode
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WorryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Mei-Chih Tseng, MD, Study director, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00491348
- Sponsor's protocol ID
- 950508
- Status last verified
- Dec 2008
- First submitted
- 23 Jun 2007
- Last updated
- 23 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Duloxetine on Pathological Worry in Patients With Generalized Anxiety Disorder: A fMRI Study
- ClinicalTrials.gov ID
- NCT00491348
- Acronym / sponsor ID
- 950508
- Keywords
- Generalized anxiety disorder, fMRI, Worry
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change of MRI mode
- Enrolment
- 23 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 26 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
(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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- DSM-IV criteria of generalized anxiety disorders with moderate degree
- Participants above 18 years old
Key exclusion criteria (11 listed)
- Major depression
- Panic disorder
- Obsessive-compulsive disorder
- Post-traumatic disorder
- Eating disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| duloxetine hydrochlorideAlso: Cymbaltaduloxetine 30 mg QD, may titrate to 30 mg BID, and maintain the dosage for 6 weeks | Drug | – |
Primary outcome
difference of brain activation on worry
Time frame: two months
Results and safety
The study was stopped early (reason given: Change of MRI mode). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mei-Chih Tseng, MD study director
NTUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing duloxetine hydrochloride in people with Worry and Anxiety, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Change of MRI mode). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference of brain activation on worry (time frame: two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2008.