Bipolar Disorder
Conditions
Brief summary
The goal of this cross-sectional study is to use diffusion-weighted imaging based tractography (DWT) to assess white matter (WM) pathways in treatment-refractory bipolar disorder (REF-BD) and treatment responsive bipolar disorder (RSP-BD) subjects compared to healthy controls (HCs). This project will include a prospective controlled trial to include 50 subjects with REF-BD, 50 patients RSP-BD and 50 healthy volunteers.
Interventions
OTHERMagnetic Resonance Imaging
Imaging data for research purposes (high-resolution T1 structural and DWI MRI) will be acquired
OTHERPsychiatric testing
Subjects will be evaluated using psychiatric assessments
OTHEREye-Tracking
Eye-tracking assessments will be done to biases toward positive and negative stimuli including images of neutral, fearful/threatening, sad, and happy.
OTHERNeuropsychology Evaluation
The neuropsychology evaluation will measure verbal learning/memory, attention/working memory, psychomotor speed, verbal fluency/processing speed, and executive function
Sponsors
National Institute of Mental Health (NIMH)
University Hospitals Cleveland Medical Center
Jennifer Sweet
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Group 1: Healthy Volunteers Inclusion Criteria for Group 1: 1. Male or female ≥18 years of age 2. Capable of understanding/complying with protocol requirements 3. Has competency to understand and sign informed consent form 4. Physically healthy with no acute medical condition and ≤3 stable, chronic medical conditions 5. Without current and/or lifetime psychiatric disorders as assessed by the Mini International Neuropsychiatric Interview for DSM-5 (MINI)
Exclusion criteria
for Group 1: 1. Acute medical condition or \>3 stable, chronic health conditions 2. Significant structural brain lesion 3. Progressive neurological disease 4. Preexisting implanted electrical device 5. Currently pregnant or planning to become pregnant 6. Contraindications to MR imaging 7. Tests positive for cannabis, illegal substances, or prescription medications without valid prescription 8. Currently taking steroids, opioids, or other agents that might affect brain circuitry per research team discretion 9. Use of cigarettes or other nicotine products within 12 hours of imaging visit 10. Use of stimulants 24 hours prior MRI visit 11. Presents an immediate danger to self or others as judged by research psychiatrist 12. Has psychiatric disorder, including alcohol/drug use disorder or personality disorder Group 2: Treatment-Responsive BDI Inclusion Criteria for Group 2: 1. Male or female ≥18 years of age 2. Capable of understanding/complying with protocol requirements 3. Has competency to understand and sign informed consent form 4. Physically healthy with no acute medical condition and ≤3 stable, chronic medical conditions 5. Meets diagnostic criteria for BDI or BDII according to the DSM-5 criteria 6. Must be stable on current BD medications with no dosing changes in the last 30 days or not currently taking any BD medications. 7. Recent mood episode must currently be in remission for \> 8 weeks 8. Montgomery-Asberg Depression Rating Scale (MADRS) ≤10 total score during the psychiatric assessments portion and at the MRI visit (if repeated at MRI visit) 9. Young Mania Rating Scale (YMRS) ≤12 total score during the psychiatric assessments portion and at the MRI visit (if repeated at MRI visit) 10. Clinical Global Impression-Severity for Bipolar Disorder (CGI-S-BD) ≤2 during the psychiatric assessments visit 11. Must be adherent (≥ 80%) with BD medication(s)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characterize white matter (WM) connectivity with DWT to identify an anatomical substrate for BD that has future potential as a therapeutic target | Day 1 | The imaging visit will consist of an MRI with diffusion-weighted imaging (DWI) sequences |
Countries
United States
Outcome results
None listed