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OpenTrials
Completed

NCT Number: NCT02253225

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

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Functional magnetic resonance imaging (fMRI)

Other

Imaging will be performed on a 3T Siemens Trio scanner. Each MRI scanning session will last no more than 90 minutes.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Brain & Behavior Research Foundation

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Oct 1, 2014
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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