Bipolar DisorderNCT02323763
An fMRI Study on Temporal Discounting in Bipolar Disorder
An observational study of Bipolar Disorder and Suicidal Ideation, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The investigators propose to explore the link between bipolar disorder, anxiety, and suicide by investigating intertemporal discounting in depressed, suicidal patients with bipolar I and II disorder who have various levels of anxiety. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder, Suicidal Ideation, Depression
- What is being tested?
- fMRI Scanning
- Type of treatment
- Injection or infusion
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2014to 29 Aug 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will recruit 30 currently depressed patients (with DSM-IV bipolar I and II disorder who are currently or previously suicidal). Enrollment will be limited to adults aged 18-65.
Who may be able to join
- Meets DSM-IV criteria for BD I and II current depressive episode
- Able to give written informed consent
- Age > to 18 years and < 65 years
- Currently suicidal as defined by a MADRS suicide item score of > 3 or previous history of serious suicidal ideation that required hospitalization.
- All subjects need to have normal hearing and normal/corrected-to-normal vision.
Who cannot join
- Medical illness or non-psychiatric medical treatment that would likely interfere with study participation
- Neurologic disorder, previous ECT, or history of head trauma (i.e. known structural brain lesion potentially confounding MRI results)
- Substance abuse within the past 3 months or current substance dependence (confirmed by MINI)
- Left-handedness
- Contraindications to MRI (metallic implants, claustrophobia, etc.)
- Subjects who need urgent psychiatric care requiring hospitalization (evaluated by clinicians).
Trial locations and contacts
1 site in 1 country.
United States1 site
Bipolar Clinic and Research Program at Massachusetts General Hospital
Boston, Massachusetts, 02144
About this study
Official title: Reconceptualizing Suicide as Impaired Temporal Discounting: an fMRI Study in Bipolar Disorder
The investigators propose to explore the link between bipolar disorder, anxiety, and suicide by investigating intertemporal discounting in depressed, suicidal patients with bipolar I and II disorder who have various levels of anxiety. The investigators will determine the effect of anxiety on their intertemporal discounting (small rewards now compared to larger rewards later) in a decision-making paradigm and investigate the associated functional neuroanatomy using functional magnetic resonance imaging (fMRI).
Read the detailed description
Among the various psychological properties of the decision making process is temporal discounting, which is a decrease in the subjective value of a good as a function of the amount of and delay to reward. The ability to decide between immediate versus future rewards depends on self-control and consideration of the future. We can reconceptualize suicide as intertemporal discounting with an interaction between cognition and mood. Someone contemplating suicide weighs the time value of costs and benefits with shifting negative and positive valence systems. To the best of our knowledge, no one has assessed the interaction between mood symptoms, anxiety, and their impact on the temporal discounting paradigm in bipolar patients. If we better understood the difference between anxious, suicidal and non-anxious, suicidal bipolar patients, we could design more effective interventions to prevent this tragic outcome. We propose a novel paradigm to explore the link between bipolar disorder, anxiety, and suicide. If we conceptualize suicidal behavior and death by suicide as decisions, then it makes sense to examine key aspects of decision making in these patients. In particular, we can examine how mood, anxiety, and suicidal ideation and behaviors arise from patterns of decision making, along with neural correlates of decision-making, as assessed with fMRI.
- Conditions
- Bipolar Disorder, Suicidal Ideation, Depression
- Being tested
- fMRI Scanning
- Keywords
- Magnetic Resonance Imaging, Bipolar Disorder, Suicidal Ideation
- Medical subject headings
- Bipolar Disorder, Suicidal Ideation, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRI ScanningOther
Imaging will be performed on a 3T Siemens Trio scanner. Each MRI scanning session will last no more than 90 minutes. fMRI will be used to determine brain activation and differences in intertemporal discounting.
| Study group | Role | What they receive |
|---|---|---|
| Bipolar I or II Disorder | 30 currently depressed patients with DSM-IV bipolar I and II disorder who are currently or previously suicidal will receive fMRI. Receives: Other: fMRI Scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Magnetic Resonance Imaging (fMRI) to examine brain activation and differences in intertemporal discounting
Functional Magnetic Resonance Imaging (fMRI) will be used to look at the neuroanatomy of intertemporal discounting in patients with bipolar I and II disorder
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 posted23 Dec 2014 (estimated)
- Study start14 Jul 2014
- Primary completion29 Aug 2016
- Study completion29 Aug 2016
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 only
- Time perspective
- Cross-sectional
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Foundation for Suicide Prevention
- Responsible party
- Principal investigator, Andrew A. Nierenberg, MD, Massachusetts General Hospital
- Investigators
- Andrew A. Nierenberg, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323763
- Sponsor's protocol ID
- 2013P000003
- Status last verified
- Feb 2017
- First submitted
- 18 Dec 2014
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconceptualizing Suicide as Impaired Temporal Discounting: an fMRI Study in Bipolar Disorder
- ClinicalTrials.gov ID
- NCT02323763
- Acronym / sponsor ID
- 2013P000003
- Conditions
- Bipolar Disorder, Suicidal Ideation, Depression
- Keywords
- Magnetic Resonance Imaging, Bipolar Disorder, Suicidal Ideation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- American Foundation for Suicide Prevention
- Study start
- 14 Jul 2014 (actual)
- Primary completion
- 29 Aug 2016 (actual)
- Study completion
- 29 Aug 2016 (actual)
- First posted
- 23 Dec 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 explore the link between bipolar disorder, anxiety, and suicide by investigating intertemporal discounting in depressed, suicidal patients with bipolar I and II disorder who have various levels of anxiety. The investigators will determine the effect of anxiety on their intertemporal discounting (small rewards now compared to larger rewards later) in a decision-making paradigm and investigate the associated functional neuroanatomy using functional magnetic resonance imaging (fMRI).
Detailed description
Among the various psychological properties of the decision making process is temporal discounting, which is a decrease in the subjective value of a good as a function of the amount of and delay to reward. The ability to decide between immediate versus future rewards depends on self-control and consideration of the future. We can reconceptualize suicide as intertemporal discounting with an interaction between cognition and mood. Someone contemplating suicide weighs the time value of costs and benefits with shifting negative and positive valence systems. To the best of our knowledge, no one has assessed the interaction between mood symptoms, anxiety, and their impact on the temporal discounting paradigm in bipolar patients. If we better understood the difference between anxious, suicidal and non-anxious, suicidal bipolar patients, we could design more effective interventions to prevent this tragic outcome. We propose a novel paradigm to explore the link between bipolar disorder, anxiety, and suicide. If we conceptualize suicidal behavior and death by suicide as decisions, then it makes sense to examine key aspects of decision making in these patients. In particular, we can examine how mood, anxiety, and suicidal ideation and behaviors arise from patterns of decision making, along with neural correlates of decision-making, as assessed with fMRI.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bipolar I or II Disorder | – | Other: fMRI Scanning30 currently depressed patients with DSM-IV bipolar I and II disorder who are currently or previously suicidal will receive fMRI. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will recruit 30 currently depressed patients (with DSM-IV bipolar I and II disorder who are currently or previously suicidal). Enrollment will be limited to adults aged 18-65.
Key inclusion criteria (5 listed)
- Meets DSM-IV criteria for BD I and II current depressive episode
- Able to give written informed consent
- Age > to 18 years and < 65 years
- Currently suicidal as defined by a MADRS suicide item score of > 3 or previous history of serious suicidal ideation that required hospitalization.
- All subjects need to have normal hearing and normal/corrected-to-normal vision.
Key exclusion criteria (6 listed)
- Medical illness or non-psychiatric medical treatment that would likely interfere with study participation
- Neurologic disorder, previous ECT, or history of head trauma (i.e. known structural brain lesion potentially confounding MRI results)
- Substance abuse within the past 3 months or current substance dependence (confirmed by MINI)
- Left-handedness
- Contraindications to MRI (metallic implants, claustrophobia, etc.)
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 |
|---|---|---|
| fMRI ScanningImaging will be performed on a 3T Siemens Trio scanner. Each MRI scanning session will last no more than 90 minutes. fMRI will be used to determine brain activation and differences in intertemporal discounting. | Other | Bipolar I or II Disorder |
Primary outcome
Functional Magnetic Resonance Imaging (fMRI) to examine brain activation and differences in intertemporal discounting
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 intertemporal discounting in patients with bipolar I and II disorder
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 9 Feb 2017.
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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.
Andrew A. Nierenberg, M.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 Suicidal Ideation, 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 5 inclusion and 6 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 9 Feb 2017. 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 brain activation and differences in intertemporal discounting (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 9 Feb 2017.