An fMRI Study on Temporal Discounting in Bipolar Disorder

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02323763
• Other study ID #: 2013P000003
• Status: Completed
• Phase: N/A
• First received: December 18, 2014
• Last updated: February 8, 2017
• Start date: July 14, 2014
• Est. completion date: August 29, 2016

Study information

• Verified date: February 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 29, 2016
• Est. primary completion date: August 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Disease
• Suicidal Ideation

Intervention

Other:
• fMRI Scanning
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.

Locations

Country	Name	City	State
United States	Bipolar Clinic and Research Program at Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	American Foundation for Suicide Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Participants will be analyzed as quickly as possible after a screening visit, an expected average of 2 weeks