Status:
TERMINATED
Brain Circuitry Analysis in Bipolar Disorder
Lead Sponsor:
Jennifer Sweet
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
University Hospitals Cleveland Medical Center
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18+ years
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 treatmen...
Eligibility Criteria
Inclusion
- Group 1: Healthy Volunteers
- Inclusion Criteria for Group 1:
- 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)
- Exclusion Criteria for Group 1:
- Acute medical condition or \>3 stable, chronic health conditions
- Significant structural brain lesion
- Progressive neurological disease
- Preexisting implanted electrical device
- Currently pregnant or planning to become pregnant
- Contraindications to MR imaging
- 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 cigarettes or other nicotine products within 12 hours of imaging visit
- Use of stimulants 24 hours prior MRI visit
- Presents an immediate danger to self or others as judged by research psychiatrist
- Has psychiatric disorder, including alcohol/drug use disorder or personality disorder
- Group 2: Treatment-Responsive BDI
- Inclusion Criteria for Group 2:
- 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)
- Exclusion Criteria for Group 2:
- Acute medical condition or \>3 stable, chronic health conditions
- Significant structural brain lesion
- Progressive neurological disease
- Preexisting implanted electrical device
- Currently pregnant or planning to become pregnant
- Contraindications to MR imaging
- 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 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
- Has had changes in medications within 30 days
- 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
- Inclusion Criteria for Group 3:
- 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
- Exclusion Criteria for Group 3:
- Acute medical condition or \>3 stable, chronic health conditions
- Significant structural brain lesion
- Progressive neurological disease
- Preexisting implanted electrical device
- Currently pregnant or planning to become pregnant
- Contraindications to MR imaging
- 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 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
- Has had changes in medications within 30 days
- 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
Exclusion
Key Trial Info
Start Date :
October 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2025
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT05186077
Start Date
October 15 2020
End Date
July 31 2025
Last Update
October 9 2025
Active Locations (1)
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1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106