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Completed

NCT Number: NCT02323763

An fMRI Study on Temporal Discounting 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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bipolar Clinic and Research Program at Massachusetts General Hospital

Boston, Massachusetts, 02144, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

fMRI Scanning

Other

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.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • American Foundation for Suicide Prevention

Registry information

Official study title

Reconceptualizing Suicide as Impaired Temporal Discounting: an fMRI Study in Bipolar Disorder

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 23, 2014
Registry last updated
Feb 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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