Brain Circuitry Analysis in Bipolar Disorder

Prior treatment

• Tests positive for cannabis, illegal substances, or prescription medications without valid prescription
• Currently taking steroids, opioids, or other agents that might affect brain circuitry per research team discretion
• Use of stimulants 24 hours prior MRI visit
• Tests positive for cannabis, illegal substances, or prescription medications without valid prescription
• Currently taking steroids, opioids, or other agents that might affect brain circuitry per research team discretion
• Has had changes in medications within 30 days
• Tests positive for cannabis, illegal substances, or prescription medications without valid prescription
• Currently taking steroids, opioids, or other agents that might affect brain circuitry per research team discretion
• Has had changes in medications within 30 days

Other illness

• Acute medical condition or >3 stable, chronic health conditions
• Progressive neurological disease
• Has psychiatric disorder, including alcohol/drug use disorder or personality disorder
  • Group 2: Treatment-Responsive BDI
• Acute medical condition or >3 stable, chronic health conditions
• Progressive neurological disease
• Contribution of any co-occurring psychiatric comorbidity disproportionate to contribution of BDI or BDII
• Meets DSM-5 criteria for current borderline or antisocial personality disorder
• Meets DSM-5 criteria for alcohol and/or drug use disorder within 6 months, excluding caffeine and/or nicotine
  • Group 3: Treatment-Refractory BDI
• Acute medical condition or >3 stable, chronic health conditions
• Progressive neurological disease
• Contribution of any co-occurring psychiatric comorbidity disproportionate to contribution of BDI or BDII
• Meets DSM-5 criteria for current borderline or antisocial personality disorder
• Meets DSM-5 criteria for alcohol and/or drug use disorder within 6 months, excluding caffeine and/or nicotine

Other

• Significant structural brain lesion
• Preexisting implanted electrical device
• Currently pregnant or planning to become pregnant
• Contraindications to MR imaging
• Use of cigarettes or other nicotine products within 12 hours of imaging visit
• Presents an immediate danger to self or others as judged by research psychiatrist
• Significant structural brain lesion
• Preexisting implanted electrical device
• Currently pregnant or planning to become pregnant
• Contraindications to MR imaging
• Use of cigarettes or other nicotine products within 12 hours of imaging visit
• Use of stimulants within 24 hours of imaging visit
• Presents an immediate danger to self or others as judged by research psychiatrist
• Significant structural brain lesion
• Preexisting implanted electrical device
• Currently pregnant or planning to become pregnant
• Contraindications to MR imaging
• Use of cigarettes or other nicotine products within 12 hours of imaging visit
• Use of stimulants within 24 hours of imaging visit
• Presents an immediate danger to self or others as judged by research psychiatrist

• Male or female ≥18 years of age
• Capable of understanding/complying with protocol requirements
• Has competency to understand and sign informed consent form
• Physically healthy with no acute medical condition and ≤3 stable, chronic medical conditions
• Without current and/or lifetime psychiatric disorders as assessed by the Mini International Neuropsychiatric Interview for DSM-5 (MINI)
• Male or female ≥18 years of age
• Capable of understanding/complying with protocol requirements
• Has competency to understand and sign informed consent form
• Physically healthy with no acute medical condition and ≤3 stable, chronic medical conditions
• Meets diagnostic criteria for BDI or BDII according to the DSM-5 criteria
• Must be stable on current BD medications with no dosing changes in the last 30 days or not currently taking any BD medications.
• Recent mood episode must currently be in remission for > 8 weeks
• Montgomery-Asberg Depression Rating Scale (MADRS) ≤10 total score during the psychiatric assessments portion and at the MRI visit (if repeated at MRI visit)
• Young Mania Rating Scale (YMRS) ≤12 total score during the psychiatric assessments portion and at the MRI visit (if repeated at MRI visit)
• Clinical Global Impression-Severity for Bipolar Disorder (CGI-S-BD) ≤2 during the psychiatric assessments visit
• Must be adherent (≥ 80%) with BD medication(s)
• Male or female ≥18 years of age
• Capable of understanding/complying with protocol requirements
• Has competency to understand and sign informed consent form
• Physically healthy with no acute medical condition and ≤3 stable, chronic medical conditions
• Meets diagnostic criteria for BDI or BDII according to the DSM-5 criteria
• Must be stable on drugs, including at least 1 mood stabilizer, with no dosing changes in the last 30 days
• GCI-S-BD >3 at the psychiatric assessments visit
• MADRS ≥20 total score or YMRS ≥18 total score during the psychiatric assessments portion and at the MRI visit (if repeated at MRI visit)
• BD-associated mood episodes are primary source of disability, according to both subject and psychiatrist
• Current depressive episode lasting ≥6 months despite ≥ 2 adequate evidence-based first-line treatment > 8 weeks, current manic/hypomanic episode lasting ≥2 months despite ≥ 2 adequate evidence-based first-line treatment > 4 weeks, or meeting rapid cycling criteria in last 12 months despite ≥2 evidence-based first-line treatments for BDI or BDII assessed with assistance of Modified Antidepressant Treatment History Form (MATHF)
• Severe impairment with score of ≥7 on at least one of three subscales of Sheehan Disability Scale (SDS), which includes assessment of work-life, family-life, and social life during the psychiatric assessments portion

Criteria the registry did not label

• Group 1: Healthy Volunteers