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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Hartford Hospital
Sponsor:
Information provided by (Responsible Party):
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT01607710
First received: May 25, 2012
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

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.


Condition
Generalized Anxiety Disorder

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Locating Regions of Interest in Generalized Anxiety Disorder Using Function Magnetic Resonance Imaging (fMRI)

Resource links provided by NLM:


Further study details as provided by Hartford Hospital:

Primary Outcome Measures:
  • Brain activation while undergoing the fMRI [ Time Frame: Throughout the fMRI ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Residents of the Greater Hartford Connecticut area.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01607710

Contacts
Contact: Gretchen J Diefenbach, Ph.D. 860-545-7396 GDiefen@harthosp.org

Locations
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06105
Contact: Gretchen J Diefenbach, Ph.D.    860-545-7396    GDiefen@harthosp.org   
Principal Investigator: Gretchen J Diefenbach, Ph.D.         
Sponsors and Collaborators
Hartford Hospital
Investigators
Principal Investigator: Gretchen J Diefenbach, Ph.D. Hartford Hospital
  More Information

No publications provided

Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT01607710     History of Changes
Other Study ID Numbers: DIEF003523.2
Study First Received: May 25, 2012
Last Updated: March 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Hartford Hospital:
fMRI
Generalized Anxiety Disorder

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014