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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02323763
Other study ID # 2013P000003
Secondary ID
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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