Brain Circuitry Analysis in Bipolar Disorder

An observational study of Bipolar Disorder, run by Jennifer Sweet at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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). Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Bipolar Disorder
What is being tested?: Magnetic Resonance Imaging, Psychiatric testing and Eye-Tracking
How many people: 26 participants
Where: 1 siteUnited States
Study dates: 15 Oct 2020to 31 Jul 2025
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

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.

Who may be able to join

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

Show all 27Show fewer

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

Who cannot join

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

Show all 44Show fewer

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
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
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

Trial locations and contacts

1 site in 1 country.

United States1 site

University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106

Other trials in United States

About this study

Conditions: Bipolar Disorder
Being tested: Magnetic Resonance Imaging, Psychiatric testing, Eye-Tracking, Neuropsychology Evaluation
Medical subject headings: Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Magnetic Resonance ImagingOther
Imaging data for research purposes (high-resolution T1 structural and DWI MRI) will be acquired
Psychiatric testingOther
Subjects will be evaluated using psychiatric assessments
Eye-TrackingOther
Eye-tracking assessments will be done to biases toward positive and negative stimuli including images of neutral, fearful/threatening, sad, and happy.
Neuropsychology EvaluationOther
The neuropsychology evaluation will measure verbal learning/memory, attention/working memory, psychomotor speed, verbal fluency/processing speed, and executive function

Study groups in NCT05186077
Study group	Role	What they receive
Healthy Controls		These participants will not have any psychiatric disorder as assessed by a structured clinical interview for psychiatric disorders. Receives: 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 Receives: 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. Receives: Other: Magnetic Resonance Imaging; Other: Psychiatric testing; Other: Eye-Tracking; Other: Neuropsychology Evaluation

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 202031 Jul 2025

First posted11 Jan 2022
Study start15 Oct 2020
Primary completion31 Jul 2025
Study completion31 Jul 2025

Why it stopped: The original funding for this study ended and we were not able to secure new funding to continue

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Bipolar DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Cross-sectional
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05186077
Sponsor's protocol ID: STUDY20201112
Other IDs: 1R56MH121598-01A1
Status last verified: Jul 2026
First submitted: 23 Dec 2021
Last updated: 6 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bipolar Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Brain Circuitry Analysis in Bipolar Disorder
ClinicalTrials.gov ID: NCT05186077
Acronym / sponsor ID: STUDY20201112
Conditions: Bipolar Disorder
Study type: Observational
Recruitment status: TerminatedReason stopped: The original funding for this study ended and we were not able to secure new funding to continue
Enrolment: 26 participants (actual)
Lead sponsor: Jennifer SweetUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH), University Hospitals Cleveland Medical Center
Study start: 15 Oct 2020 (actual)
Primary completion: 31 Jul 2025 (actual)
Study completion: 31 Jul 2025 (actual)
First posted: 11 Jan 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case-control
Time perspective: Cross-sectional
Number of arms: 3

Arm	Type	Receives
Healthy Controls	–	Other: Magnetic Resonance ImagingThese participants will not have any psychiatric disorder as assessed by a structured clinical interview for psychiatric disorders.
Treatment-Responsive BD	–	Other: Magnetic Resonance Imaging, Other: Psychiatric testing, Other: Eye-Tracking, Other: Neuropsychology EvaluationThis 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
Treatment-Refractory BD	–	Other: Magnetic Resonance Imaging, Other: Psychiatric testing, Other: Eye-Tracking, Other: Neuropsychology EvaluationThis 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (27 listed)

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)

Key exclusion criteria (44 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Magnetic Resonance ImagingImaging data for research purposes (high-resolution T1 structural and DWI MRI) will be acquired	Other	Healthy Controls, Treatment-Refractory BD, Treatment-Responsive BD
Psychiatric testingSubjects will be evaluated using psychiatric assessments	Other	Treatment-Refractory BD, Treatment-Responsive BD
Eye-TrackingEye-tracking assessments will be done to biases toward positive and negative stimuli including images of neutral, fearful/threatening, sad, and happy.	Other	Treatment-Refractory BD, Treatment-Responsive BD
Neuropsychology EvaluationThe neuropsychology evaluation will measure verbal learning/memory, attention/working memory, psychomotor speed, verbal fluency/processing speed, and executive function	Other	Treatment-Refractory BD, Treatment-Responsive BD

Primary outcome

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

Results and safety

The study was stopped early (reason given: The original funding for this study ended and we were not able to secure new funding to continue). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.

Related trials for Bipolar Disorder

RecruitingObservational study
Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions
Esophageal Neoplasm, Esophageal Polyp
Recruiting
Unipolar Versus Bipolar Radiofrequency Ablation in Knee Osteoarthritis Pain
Bipolar Radiofrequency Ablation, Unipolar Radiofrequency Ablation
RecruitingPhase 2
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RecruitingPhase 3
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
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Recruiting
Evaluation of the Impact of the EDIT-B® Blood Test on the Health Status of Patients Presenting a Major Depressive Episode. Clinical Utility and Medico-Economic Aspects
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jennifer Sweet, MD principal investigator

University Hospitals Cleveland Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Bipolar Disorder, run by Jennifer Sweet at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The original funding for this study ended and we were not able to secure new funding to continue). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05186077.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.