Can electrical stimulation reduce brain activity in brain regions involved in reward responses linked to risk-taking behavior in people with bipolar disorder?

Not Applicable

Completed

• Conditions: Bipolar disorder; Mental and Behavioural Disorders

• Registration Number: ISRCTN11314056
• Lead Sponsor: niversity of Pittsburgh

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31664174 (added 24/01/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-12-13
• Study Start: 2019-02-13
• Last Update Posted: 10 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

All participants:
1. Right-handed (Annett criteria)
2. Aged 18-45 years
3. Able to give basic informed consent
4. Women of childbearing potential must agree to a urine pregnancy test

Adults with no psychiatric history (healthy controls):
5. No previous/present psychiatric history of any disorder including Substance Use Disorders (SCID-5 criteria)
6. No family history of psychiatric illness (Family History Questionnaire criteria)

Adults with Bipolar Disorder I (BDI):
7. In remission with a diagnosis of BDI (DSM-5 criteria; euthymic for more than 2 months)
8. Any antidepressant, any mood stabilizer, any atypical antipsychotic, or any combination of atypical antipsychotics and/or mood stabilizers and/or antidepressants taken for 2 months or longer or unmedicated individuals

Exclusion Criteria

All participants:
1. Not native English speaking or not fluent
2. History of head injury/severe concussion, neurological, pervasive developmental disorder (e.g. autism), or systemic medical disease (that could impact fMRI scans; from medical records and report by each potential participant)
3. Mini-Mental State Examination (cognitive state) score <24
4. Premorbid NAART IQ estimate <85
5. Visual disturbance (<20/40 Snellen visual acuity) with correction or either contacts or glasses
6. Left/mixed handedness (Annett criteria), to ensure a uniform hemispheric dominance for interpretation of neuroimaging data
7. MRI screening: to exclude individuals with ferromagnetic foreign objects, e.g., surgical implants, and individuals prone to claustrophobia; and a positive pregnancy test for females (performed at the MRRC) or self-report pregnancy; being too physically large to fit in the scanner (greater than 55 inches chest circumference)
8. Active suicidal ideation

Adults with Bipolar Disorder I (BDI):
9. Not being in remission with a diagnosis of BDI (DSM-5 criteria; euthymic for 2 months or less)
10. If medicated, not on any combination of atypical antipsychotics and/or mood stabilizers and/or antidepressants taken for two months or longer
11. History of alcohol/substance abuse/dependence (including nicotine) and/or illicit substance use (except cannabis) over the last 3 months, determined by Structured Clinical Interview for DSM-5 (SCID-5). Lifetime/present cannabis use (non-abuse levels) will be allowed, given its common usage in individuals with BD. Urine tests on the scan day will exclude individuals with current illicit substance use (except cannabis); salivary alcohol tests will exclude individuals who are intoxicated on the scan day. Alcohol/nicotine/caffeine/cannabis use (below SCID-5 abuse/dependence levels) per week will be allowed, recorded for all individuals
12. Score >7 on the Hamilton Rating Scale for Depression (HRDS)
13. Score >10 on the Young Mania Rating Scale (YMRS)
14. Psychotic: Score of 3 or more on suspiciousness, hallucinations, unusual thought content subscales of the Brief Psychiatric Rating Scale (BPRS)

Adults with no psychiatric history (healthy controls):
15. Lifetime history of alcohol/substance abuse/dependence (including nicotine) and/or illicit substance use (except cannabis), determined by Structured Clinical Interview for DSM-5 (SCID-5)(50). Urine tests on the scan day will exclude individuals with current illicit substance use (except cannabis); salivary alcohol tests will exclude individuals who are intoxicated on the scan day. Alcohol/nicotine/caffeine/cannabis use (below SCID-5 abuse/dependence levels) per week will be allowed, recorded for all individuals
16. Lifetime history of psychotropic medicine use
17. First degree relative with Axis I disorder
18. Present/previous personal history of psychiatric illness in childhood or after the age of 18 years (SCID-I)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Reward expectancy (RE) activation assessed using blood-oxygen-level dependent (BOLD) signal change in MRI scan at the scan visit of left vlPFC, VS and amygdala,<br> using as regions of interest the left vlPFC mask created from previous studies of reward processing in BD, a VS mask based on prior reward-related activation loci with the same paradigm, and an amygdala mask, using the SPM atlas toolbox (http://fmri.wfubmc.edu/)<br> 2. RE functional connectivity measured by extracted parameter estimates in the brain by MRI at the scan visit<br><br><br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Prediction error (PE)-related VS activation measured by BOLD signal change in the brain by MRI at the scan visit<br><br> Added 27/02/2019:<br> 2. Risky decision making is measured by performance on a risky decision making task, which occurs after each scan<br> 3. Affect is measured by the Hamilton Rating Scale for Depression (HRSD) and Young Mania Rating Scale (YMRS) at the screen visit as well as before and after each scan<br>