Self Focus in Bipolar Disorder: A Functional Magnetic Resonance Imaging (fMRI) Study

Bipolar Disorder Clinical Trial

Official title:

An fMRI Study of Self Processing and Self Focus in Major Depression and Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02253225
• Other study ID #: 2012P000714
• Secondary ID: 19531
• Status: Completed
• Start date: January 2013
• Est. completion date: January 2020

Study information

• Verified date: August 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depression
• Rumination

Intervention

Other:
• Functional Magnetic Resonance Imaging (fMRI)
Imaging will be performed on a 3T Siemens Trio scanner. Each MRI scanning session will last no more than 90 minutes.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Brain & Behavior Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Magnetic Resonance Imaging (fMRI) to examine self processing and self focus	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