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

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

    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

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

16 years to 62 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).
Imaging will be performed on a 3T Siemens Trio scanner. Each MRI scanning session will last no more than 90 minutes.
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
Functional Magnetic Resonance Imaging (fMRI) will be used to look at the neuroanatomy of self processing and self focus.
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.

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

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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