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

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

    • Massachusetts
      • Boston, Massachusetts, United States, 02144
        • Bipolar Clinic and Research Program at Massachusetts General Hospital

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:

  1. Meets DSM-IV criteria for BD I and II current depressive episode
  2. Able to give written informed consent
  3. Age > to 18 years and < 65 years
  4. Currently suicidal as defined by a MADRS suicide item score of > 3 or previous history of serious suicidal ideation that required hospitalization.
  5. All subjects need to have normal hearing and normal/corrected-to-normal vision.

Exclusion Criteria:

  1. Medical illness or non-psychiatric medical treatment that would likely interfere with study participation
  2. Neurologic disorder, previous ECT, or history of head trauma (i.e. known structural brain lesion potentially confounding MRI results)
  3. Substance abuse within the past 3 months or current substance dependence (confirmed by MINI)
  4. Left-handedness
  5. Contraindications to MRI (metallic implants, claustrophobia, etc.)
  6. 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.
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.

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
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.

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

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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