An fMRI Study on Temporal Discounting in Bipolar Disorder

NCT02323763 | Completed

• 1 other identifier: 2013P000003
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Bipolar Disorder; Suicidal Ideation; Depression

Keywords

Magnetic Resonance Imaging; Bipolar Disorder; Suicidal Ideation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Other: fMRI Scanning

Interventions

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.

Bipolar I or II Disorder

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• American Foundation for Suicide Prevention: collaborator

Study Sites (1)

Bipolar Clinic and Research Program at Massachusetts General Hospital

Boston, Massachusetts, 02144, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Suicidal Ideation; Depression

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Andrew A. Nierenberg, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: December 23, 2014
• Study Start: July 14, 2014
• Primary Completion: August 29, 2016
• Study Completion: August 29, 2016
• Last Updated: February 9, 2017

Record last verified: 2017-02

Locations

US (1)