Generalized Anxiety DisorderfMRINCT01607710
Locating Regions of Interest in Generalized Anxiety Disorder Using Function Magnetic Resonance Imaging (fMRI)
An observational study of Generalized Anxiety Disorder, run by Hartford Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Generalized Anxiety Disorder
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Residents of the Greater Hartford Connecticut area.
Who may be able to join
- 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
- Absence of any psychiatric diagnosis
Who cannot join
- 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
Show all 23Show fewer
- 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:
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Generalized Anxiety Disorder
- Keywords
- fMRI, Generalized Anxiety Disorder
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout the fMRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gretchen J Diefenbach, Ph.D., Principal investigator, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607710
- Sponsor's protocol ID
- DIEF003523.2
- Acronym
- fMRI
- Status last verified
- Mar 2013
- First submitted
- 25 May 2012
- Last updated
- 5 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locating Regions of Interest in Generalized Anxiety Disorder Using Function Magnetic Resonance Imaging (fMRI)
- ClinicalTrials.gov ID
- NCT01607710
- Acronym / sponsor ID
- fMRI / DIEF003523.2
- Conditions
- Generalized Anxiety Disorder
- Keywords
- fMRI, Generalized Anxiety Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 30 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Generalized Anxiety Disorder | – | –The group of participants diagnosed with generalized anxiety disorder. |
| Nonclinical Control Group | – | –The comparison group of participants with no psychiatric diagnoses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of the Greater Hartford Connecticut area.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gretchen J Diefenbach, Ph.D. principal investigator
Hartford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Generalized Anxiety Disorder, run by Hartford Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain activation while undergoing the fMRI (time frame: Throughout the fMRI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2014.