NCT00491348

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 26, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

December 23, 2008

Status Verified

December 1, 2008

Enrollment Period

1.6 years

First QC Date

June 23, 2007

Last Update Submit

December 21, 2008

Conditions

WorryAnxiety

Keywords

Generalized anxiety disorderfMRIWorry

Outcome Measures

Primary Outcomes (1)

  • difference of brain activation on worry

    two months

Interventions

duloxetine hydrochlorideDRUG

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

Also known as: Cymbalta

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DSM-IV criteria of generalized anxiety disorders with moderate degree
  • Participants above 18 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Anxiety DisordersGeneralized Anxiety Disorder

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Mei-Chih Tseng, MD

    NTUH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 23, 2007

First Posted

June 26, 2007

Study Start

April 1, 2007

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

December 23, 2008

Record last verified: 2008-12

Locations

TW(1)