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

NCT02253225 | Completed

• 2 other identifiers: 2012P00071419531
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Major Depression; Rumination

Keywords

Bipolar Disorder; Major Depression; Rumination; Self Processing

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Bipolar Disorder

Clinical status will be determined using the Mini International Neuropsychiatric Interview (M.I.N.I) for 20 patients with bipolar disorder (BPAD).

Other: Functional Magnetic Resonance Imaging (fMRI)

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).

Other: Functional Magnetic Resonance Imaging (fMRI)

Healthy Control

Clinical status will be determined using the Mini International Neuropsychiatric Interview (M.I.N.I) for 20 normal, healthy volunteers.

Other: Functional Magnetic Resonance Imaging (fMRI)

Interventions

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.

Bipolar Disorder; Healthy Control; Major Depressive Disorder

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Right-handed (as determined by the Handedness Inventory; Oldfield, 1971)
• Normal or corrected-to normal vision and hearing

You may not qualify if:

• 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)
• Current diagnosis of MDD
• Right-handed (as determined by the Handedness Inventory; Oldfield, 1971)
• Normal or corrected-to normal vision and hearing
• 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)
• Current diagnosis of BPAD
• Right-handed (as determined by the Handedness Inventory; Oldfield, 1971)
• Normal or corrected-to normal vision and hearing
• If a history of substance abuse, at least 6 months in remission
• Current suicidal ideation or history of suicide attempts

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Brain & Behavior Research Foundation: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Depressive Disorder, Major; Rumination Syndrome

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Depressive Disorder; Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders

Study Officials

• Sharmin Ghaznavi, M.D., Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Psychiatrist

Study Record Dates

• First Submitted: September 24, 2014
• First Posted: October 1, 2014
• Study Start: January 1, 2013
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: September 1, 2021

Record last verified: 2021-08

Locations

US (1)