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CompletedNCT01607710fMRIUpdated Sep 5, 2014

Locating Regions of Interest in Generalized Anxiety Disorder Using Function Magnetic Resonance Imaging (fMRI)

An observational study in Generalized Anxiety Disorder, sponsored by Hartford Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-05.

Sponsored by Hartford Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
55
Ages
18 Years and older
Sex
All
01

Study summary

The investigators are seeking to locate the brain regions of interest in generalized anxiety disorder (GAD) using both structural (sMRI) and functional magnetic resonance imaging (fMRI). The MRI will be used to measure changes in blood flow in the brain while at rest and while completing tasks designed to elicit symptoms of anxiety. Results from a nonclinical control group and a GAD group will be compared to determine whether they exhibit different areas of brain activity during the tasks.

Read the detailed description

20 healthy controls and 20 participants with GAD will be recruited. Each participant will undergo an MRI session that will last approximately 2 hours. The structural MRI will be used when the participant is at rest. During the functional MRI (fMRI), a computer screen inside the scanner will display four tasks the participant must complete: (1)Gambling Task, (2)Risk \& Ambiguity Task, (3)Reading Emotion from the Eyes (REE) Task, and (4)Emotional Counting Task.

02

Conditions studied

  • Generalized Anxiety Disorder

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Keywords

  • fMRI
  • Generalized Anxiety Disorder
03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 55 is below the median of 150 across 606 observational studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Hartford Hospital is the lead sponsor of 101 studies on the registry; 19 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Residents of the Greater Hartford Connecticut area.

Eligibility criteria

Generalized Anxiety Disorder(GAD)Group:

Inclusion Criteria:

  • Clinical diagnosis of Generalized Anxiety Disorder
  • Hamilton Anxiety Rating Scale score of 18 or higher
  • Hamilton Rating Scale for Depression score of 17 or less
  • Fluency in English
  • Capacity to understand the nature of the study and willingness to sign informed consent for

Exclusion Criteria:

  • History of epilepsy or head trauma (Loss of consciousness>5 minutes) with the past 6 months
  • Lifetime history of increased intracranial pressure, seizure disorder, stroke, brain tumor, multiple sclerosis or brain surgery
  • A review of patient medications by the study physician indicates an increased risk of seizure
  • An active autoimmune, endocrine, viral, or vascular disorder affecting the brain; any unstable cardiac disease; hypertension; or severe renal or liver insufficiency
  • Substance use disorder or posttraumatic stress disorder (PTSD) within the past 6 months
  • Lifetime bipolar disorder, obsessive-compulsive disorder (OCD), psychotic disorder, mental retardation, or pervasive development disorder
  • Any psychotic features, including dementia or delirium
  • Medication change within past 3 months
  • Current serious suicidal or homicidal ideation, and/or serious suicidal attempt within past 6 months
  • Serious, unstable, or terminal medical condition or clinically judged too psychiatrically unstable to participate in the study
  • Any contraindication for participation in MRI scan

Nonclinical Control Group:

Inclusion Criteria:

  • Absence of any psychiatric diagnosis

Exclusion Criteria:

  • History of epilepsy or head trauma (Loss of Consciousness>5 minutes) with the past 6 months
  • Lifetime history of increased intracranial pressure, seizure disorder, stroke, brain tumor, multiple sclerosis or brain surgery
  • A review of patient medications by the study physician indicates an increased risk of seizure
  • An active autoimmune, endocrine, viral, or vascular disorder affecting the brain; any unstable cardiac disease; hypertension; or severe renal or liver insufficiency
  • Substance use disorder or PTSD within the past 6 months
  • Lifetime bipolar disorder, OCD, psychotic disorder, mental retardation, or pervasive development disorder
  • Any psychotic features, including dementia or delirium
  • Medication change within past 3 months
  • Current serious suicidal or homicidal ideation, and/or serious suicidal attempt within past 6 months
  • Serious, unstable, or terminal medical condition or clinically judged too psychiatrically unstable to participate in the study
  • Any contraindication for participation in MRI scan
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
55 participants (actual)
Patient registry
No

Groups and cohorts

  • Generalized Anxiety Disorder

    The group of participants diagnosed with generalized anxiety disorder.

  • Nonclinical Control Group

    The comparison group of participants with no psychiatric diagnoses.

06

What researchers measure

Primary outcomes

  1. Brain activation while undergoing the fMRI

    Main effects for each condition will be calculated to elucidate brain activations relevant to the tasks. Random effect 2 sample t-tests will assess group differences (i.e., GAD patients vs. healthy controls) to identify regions that demonstrate hyperactivation in patients.

    Time frame: Throughout the fMRI

07

Study locations

1 site
  • Hartford Hospital
    Hartford, Connecticut 06105, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01607710
Lead sponsor
Hartford Hospital
Responsible party
Sponsor
First posted
May 30, 2012
Start date
Jul 2012
Primary completion
Jun 2014
Completion
Jun 2014
Last update
Sep 5, 2014

Study contacts

Gretchen J Diefenbach, Ph.D.
principal investigator · Hartford Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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