Clinical trial NCT02253225: Self Focus in Bipolar Disorder: A Functional Magnetic Resonance Imaging (fMRI) Study
Official title: An fMRI Study of Self Processing and Self Focus in Major Depression and Bipolar Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Major Depression
Rumination
Keywords: Bipolar Disorder
Major Depression
Rumination
Self Processing
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Brain & Behavior Research Foundation
First posted: 2014-10-01
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Functional Magnetic Resonance Imaging (fMRI) to examine self processing and self focus
timeFrame: Participants will be analyzed as quickly as possible after a screening visit, an expected average of 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Sharmin Ghaznavi, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: