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

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.

Study Overview

• Status: Completed
• Conditions: Generalized Anxiety Disorder

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.

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06105
      • Hartford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Residents of the Greater Hartford Connecticut area.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Generalized Anxiety Disorder; The group of participants diagnosed with generalized anxiety disorder.
Nonclinical Control Group; The comparison group of participants with no psychiatric diagnoses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Throughout the fMRI

Collaborators and Investigators

• Sponsor: Hartford Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: May 25, 2012
• First Submitted That Met QC Criteria: May 29, 2012
• First Posted (Estimate): May 30, 2012

Study Record Updates

• Last Update Posted (Estimate): September 5, 2014
• Last Update Submitted That Met QC Criteria: September 4, 2014
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Generalized Anxiety Disorder; fMRI
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Anxiety Disorders
• Other Study ID Numbers: DIEF003523.2