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TerminatedNCT05186077Updated Jul 6, 2026

Brain Circuitry Analysis in Bipolar Disorder

An observational study in Bipolar Disorder, sponsored by Jennifer Sweet. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-06.

Sponsored by Jennifer Sweet · Observational

Why this study was terminated
The original funding for this study ended and we were not able to secure new funding to continue
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
26
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Bipolar Disorder

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03

In context

Bipolar Disorder

1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.

This study's enrollment of 26 is below the median of 160 across 329 observational studies indexed under Bipolar Disorder.

Browse Bipolar Disorder studies →

Lead sponsor

This is the only study on the registry with Jennifer Sweet as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Participants from all three groups will be made up of those who respond to IRB approved advertisements or are referred by a provider within the UHCMC Department of Psychiatry or other provider referral.

Eligibility 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)

Exclusion Criteria for Group 2:

  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 within 24 hours of imaging visit
  11. Presents an immediate danger to self or others as judged by research psychiatrist
  12. Has had changes in medications within 30 days
  13. Contribution of any co-occurring psychiatric comorbidity disproportionate to contribution of BDI or BDII
  14. Meets DSM-5 criteria for current borderline or antisocial personality disorder
  15. 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:

  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 drugs, including at least 1 mood stabilizer, with no dosing changes in the last 30 days
  7. GCI-S-BD >3 at the psychiatric assessments visit
  8. MADRS ≥20 total score or YMRS ≥18 total score during the psychiatric assessments portion and at the MRI visit (if repeated at MRI visit)
  9. BD-associated mood episodes are primary source of disability, according to both subject and psychiatrist
  10. 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)
  11. 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:

  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 within 24 hours of imaging visit
  11. Presents an immediate danger to self or others as judged by research psychiatrist
  12. Has had changes in medications within 30 days
  13. Contribution of any co-occurring psychiatric comorbidity disproportionate to contribution of BDI or BDII
  14. Meets DSM-5 criteria for current borderline or antisocial personality disorder
  15. Meets DSM-5 criteria for alcohol and/or drug use disorder within 6 months, excluding caffeine and/or nicotine
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
26 participants (actual)
Patient registry
No

Groups and cohorts

  • Healthy Controls

    These participants will not have any psychiatric disorder as assessed by a structured clinical interview for psychiatric disorders.

    Other: Magnetic Resonance Imaging

  • Treatment-Responsive BD

    This group will be composed of participants who have BDI or BDII and have most recently been depressed but are currently in remission with evidence-based treatments for bipolar disorder

    Other: Magnetic Resonance Imaging · Other: Psychiatric testing · Other: Eye-Tracking · Other: Neuropsychology Evaluation

  • Treatment-Refractory BD

    This group will be composed of participants who have BDI or BDII, are currently depressed or manic with their current episode lasting at least 6months and not responding to 2 or more adequate evidence-based treatments for BDI or BDII.

    Other: Magnetic Resonance Imaging · Other: Psychiatric testing · Other: Eye-Tracking · Other: Neuropsychology Evaluation

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

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What researchers measure

Primary outcomes

  1. Characterize white matter (WM) connectivity with DWT to identify an anatomical substrate for BD that has future potential as a therapeutic target

    The imaging visit will consist of an MRI with diffusion-weighted imaging (DWI) sequences

    Time frame: Day 1

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Study locations

1 site
  • University Hospitals Cleveland Medical Center
    Cleveland, Ohio 44106, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05186077
Lead sponsor
Jennifer Sweet
Collaborators
National Institute of Mental Health (NIMH), University Hospitals Cleveland Medical Center
Responsible party
Jennifer Sweet (Principal Investigator, Case Western Reserve University) — Sponsor-investigator
First posted
Jan 11, 2022
Start date
Oct 15, 2020
Primary completion
Jul 31, 2025
Completion
Jul 31, 2025
Last update
Jul 6, 2026

Study contacts

Jennifer Sweet, MD
principal investigator · University Hospitals Cleveland Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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