- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02323763
An fMRI Study on Temporal Discounting in Bipolar Disorder
February 8, 2017 updated by: Andrew A. Nierenberg, MD, Massachusetts General Hospital
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
28
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02144
- Bipolar Clinic and Research Program at Massachusetts General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Functional Magnetic Resonance Imaging (fMRI) will be used to look at the neuroanatomy of intertemporal discounting in patients with bipolar I and II disorder
|
Participants will be analyzed as quickly as possible after a screening visit, an expected average of 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 14, 2014
Primary Completion (Actual)
August 29, 2016
Study Completion (Actual)
August 29, 2016
Study Registration Dates
First Submitted
December 18, 2014
First Submitted That Met QC Criteria
December 18, 2014
First Posted (Estimate)
December 23, 2014
Study Record Updates
Last Update Posted (Estimate)
February 9, 2017
Last Update Submitted That Met QC Criteria
February 8, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013P000003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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