Skip to main content
OpenTrials
Completed

NCT Number: NCT01607710

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hartford Hospital

Hartford, Connecticut, 06105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Brain activation while undergoing the fMRI

    Time frame: Throughout 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.

Sponsors and collaborators

Lead sponsor

Hartford Hospital

Other

Registry information

Acronym: fMRI

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 30, 2012
Registry last updated
Sep 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.