Brain Circuitry Analysis in Bipolar Disorder

July 1, 2026 updated by: Jennifer Sweet
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Healthy Controls
These participants will not have any psychiatric disorder as assessed by a structured clinical interview for psychiatric disorders.
Other: Magnetic Resonance Imaging
Imaging data for research purposes (high-resolution T1 structural and DWI MRI) will be acquired
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
Imaging data for research purposes (high-resolution T1 structural and DWI MRI) will be acquired
Other: Psychiatric testing
Subjects will be evaluated using psychiatric assessments
Other: Eye-Tracking
Eye-tracking assessments will be done to biases toward positive and negative stimuli including images of neutral, fearful/threatening, sad, and happy.
Other: Neuropsychology Evaluation
The neuropsychology evaluation will measure verbal learning/memory, attention/working memory, psychomotor speed, verbal fluency/processing speed, and executive function
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
Imaging data for research purposes (high-resolution T1 structural and DWI MRI) will be acquired
Other: Psychiatric testing
Subjects will be evaluated using psychiatric assessments
Other: Eye-Tracking
Eye-tracking assessments will be done to biases toward positive and negative stimuli including images of neutral, fearful/threatening, sad, and happy.
Other: Neuropsychology Evaluation
The neuropsychology evaluation will measure verbal learning/memory, attention/working memory, psychomotor speed, verbal fluency/processing speed, and executive function

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Characterize white matter (WM) connectivity with DWT to identify an anatomical substrate for BD that has future potential as a therapeutic target
Time Frame: Day 1
The imaging visit will consist of an MRI with diffusion-weighted imaging (DWI) sequences
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jennifer Sweet

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
University Hospitals Cleveland Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer Sweet, MD, University Hospitals Cleveland Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY20201112
  • 1R56MH121598-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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