Bipolar DisorderNCT02253225
Self Focus in Bipolar Disorder: A Functional Magnetic Resonance Imaging (fMRI) Study
An observational study of Bipolar Disorder and Major Depression, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Major Depression, Rumination
- What is being tested?
- Functional Magnetic Resonance Imaging (fMRI)
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Right-handed (as determined by the Handedness Inventory; Oldfield, 1971)
- Normal or corrected-to normal vision and hearing
- Current diagnosis of MDD
- Right-handed (as determined by the Handedness Inventory; Oldfield, 1971)
- Normal or corrected-to normal vision and hearing
- Current diagnosis of BPAD
- Right-handed (as determined by the Handedness Inventory; Oldfield, 1971)
- Normal or corrected-to normal vision and hearing
Who cannot join
- 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)
- If a history of substance abuse, at least 6 months in remission
- Current suicidal ideation or history of suicide attempts
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- Positive MR screen (e.g., metal implant, claustrophobia, etc)
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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.
Read the 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.
- Conditions
- Bipolar Disorder, Major Depression, Rumination
- Being tested
- Functional Magnetic Resonance Imaging (fMRI)
- Keywords
- Bipolar Disorder, Major Depression, Rumination, Self Processing
- Medical subject headings
- Bipolar Disorder, Depressive Disorder, Major, Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Bipolar Disorder | Clinical status will be determined using the Mini International Neuropsychiatric Interview (M.I.N.I) for 20 patients with bipolar disorder (BPAD). Receives: 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). Receives: 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. Receives: Other: Functional Magnetic Resonance Imaging (fMRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants will be analyzed as quickly as possible after a screening visit, an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startJan 2013
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Responsible party
- Principal investigator, Sharmin Ghaznavi, Massachusetts General Hospital
- Investigators
- Sharmin Ghaznavi, M.D., Ph.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253225
- Sponsor's protocol ID
- 2012P000714
- Other IDs
- 19531
- Status last verified
- Aug 2021
- First submitted
- 24 Sep 2014
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An fMRI Study of Self Processing and Self Focus in Major Depression and Bipolar Disorder
- ClinicalTrials.gov ID
- NCT02253225
- Acronym / sponsor ID
- 2012P000714
- Conditions
- Bipolar Disorder, Major Depression, Rumination
- Keywords
- Bipolar Disorder, Major Depression, Rumination, Self Processing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Study start
- Jan 2013
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 1 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bipolar Disorder | – | Other: Functional Magnetic Resonance Imaging (fMRI)Clinical status will be determined using the Mini International Neuropsychiatric Interview (M.I.N.I) for 20 patients with bipolar disorder (BPAD). |
| Major Depressive Disorder | – | Other: Functional Magnetic Resonance Imaging (fMRI)Clinical status will be determined using the Mini International Neuropsychiatric Interview (M.I.N.I) for 20 patients with major depression (MDD). |
| Healthy Control | – | Other: Functional Magnetic Resonance Imaging (fMRI)Clinical status will be determined using the Mini International Neuropsychiatric Interview (M.I.N.I) for 20 normal, healthy volunteers. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (8 listed)
- Right-handed (as determined by the Handedness Inventory; Oldfield, 1971)
- Normal or corrected-to normal vision and hearing
- Current diagnosis of MDD
- Right-handed (as determined by the Handedness Inventory; Oldfield, 1971)
- Normal or corrected-to normal vision and hearing
Key exclusion criteria (10 listed)
- 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)
- If a history of substance abuse, at least 6 months in remission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Bipolar Disorder, Healthy Control, Major Depressive Disorder |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharmin Ghaznavi, M.D., Ph.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder and Major Depression, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.