- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02253225
Self Focus in Bipolar Disorder: A Functional Magnetic Resonance Imaging (fMRI) Study
August 31, 2021 updated by: Sharmin Ghaznavi, Massachusetts General Hospital
An fMRI Study of Self Processing and Self Focus in Major Depression and Bipolar Disorder
The investigators propose to examine both resting state activity and functional activity during rumination and during self-processing to study the relationship between neural correlates of rumination/self-focus and self-processing in major depression and bipolar disorder.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Negative rumination, a specific form of self-focus, characterized by repetitively focusing on one's symptoms of distress, and the possible causes and consequences of these symptoms, is a hallmark of depression.
Nearly a decade of research has culminated in evidence that the tendency to engage in negative rumination is highly correlated with depressive symptoms.
Rumination also plays a critical role in the etiology and maintenance of depressed states and predicts risk for mania in bipolar disorder.
Despite the central role of rumination in major depression and bipolar disorder, there have been few studies to date investigating the functional neuroanatomy of negative rumination, and no studies of positive rumination.
The few neuroimaging studies that have utilized measures of the tendency to engage in negative rumination have focused on brain functioning when performing tasks that involve processing emotional or self-referential stimuli, but they have not studied resting state activity or functional activity during negative and positive rumination.
We are examining both resting state activity and functional activity during negative and positive rumination and during self-processing to study the relationship between the neural correlates of rumination/self-focus and self-processing in major depression and bipolar disorder.
Study Type
Observational
Enrollment (Actual)
32
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy controls will be recruited through email announcements at MGH, internet website at Harvard, and flyers posted at the Massachusetts General Hospital and in the community (e.g., community centers, public libraries, coffee shops, restaurants, and laundromats).
Subjects with major depression will be recruited through the Depression Clinic and Research Program at MGH and flyers posted at MGH. Subjects with bipolar disorder will be recruited through the Bipolar Clinic and Research Program at MGH and flyers posted at MGH.
Description
Inclusion Criteria Healthy Controls:
- Right-handed (as determined by the Handedness Inventory; Oldfield, 1971)
- Normal or corrected-to normal vision and hearing
Exclusion Criteria for Healthy Controls:
- Any current or past psychiatric history
- Significant medical, psychiatric or neurological illness
- Currently taking antidepressants, mood stabilizers, or benzodiazepines
- Positive MR screen (e.g., metal implant, claustrophobia, etc)
Inclusion Criteria for Patients with Major Depression:
- Current diagnosis of MDD
- Right-handed (as determined by the Handedness Inventory; Oldfield, 1971)
- Normal or corrected-to normal vision and hearing
Exclusion Criteria for MDD Patients:
- If a history of substance abuse, at least 6 months in remission
- Current suicidal ideation or history of suicide attempts
- Positive MR screen (e.g., metal implant, claustrophobia, etc)
Inclusion Criteria for patients with BPAD:
- Current diagnosis of BPAD
- Right-handed (as determined by the Handedness Inventory; Oldfield, 1971)
- Normal or corrected-to normal vision and hearing
Exclusion Criteria for BPAD Patients:
- If a history of substance abuse, at least 6 months in remission
- Current suicidal ideation or history of suicide attempts
- Positive MR screen (e.g., metal implant, claustrophobia, etc)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Bipolar Disorder
Clinical status will be determined using the Mini International Neuropsychiatric Interview (M.I.N.I) for 20 patients with bipolar disorder (BPAD).
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Imaging will be performed on a 3T Siemens Trio scanner.
Each MRI scanning session will last no more than 90 minutes.
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|
Major Depressive Disorder
Clinical status will be determined using the Mini International Neuropsychiatric Interview (M.I.N.I) for 20 patients with major depression (MDD).
|
Imaging will be performed on a 3T Siemens Trio scanner.
Each MRI scanning session will last no more than 90 minutes.
|
|
Healthy Control
Clinical status will be determined using the Mini International Neuropsychiatric Interview (M.I.N.I) for 20 normal, healthy volunteers.
|
Imaging will be performed on a 3T Siemens Trio scanner.
Each MRI scanning session will last no more than 90 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Magnetic Resonance Imaging (fMRI) to examine self processing and self focus
Time Frame: Participants will be analyzed as quickly as possible after a screening visit, an expected average of 2 weeks
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Functional Magnetic Resonance Imaging (fMRI) will be used to look at the neuroanatomy of self processing and self focus.
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Participants will be analyzed as quickly as possible after a screening visit, an expected average of 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sharmin Ghaznavi, M.D., Ph.D., Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
January 1, 2020
Study Completion (Actual)
January 1, 2020
Study Registration Dates
First Submitted
September 24, 2014
First Submitted That Met QC Criteria
September 26, 2014
First Posted (Estimate)
October 1, 2014
Study Record Updates
Last Update Posted (Actual)
September 1, 2021
Last Update Submitted That Met QC Criteria
August 31, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012P000714
- 19531 (Other Grant/Funding Number: Brain and Behavior Research Foundation)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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