Brain Circuitry Analysis in Bipolar Disorder

NCT05186077 | Terminated DMC

• 2 other identifiers: STUDY202011121R56MH121598-01A1
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Bipolar Disorder

Outcome Measures

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

  Day 1

Study Arms (3)

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

Magnetic Resonance Imaging OTHER

Imaging data for research purposes (high-resolution T1 structural and DWI MRI) will be acquired

Healthy Controls; Treatment-Refractory BD; Treatment-Responsive BD

Psychiatric testing OTHER

Subjects will be evaluated using psychiatric assessments

Treatment-Refractory BD; Treatment-Responsive BD

Eye-Tracking OTHER

Eye-tracking assessments will be done to biases toward positive and negative stimuli including images of neutral, fearful/threatening, sad, and happy.

Treatment-Refractory BD; Treatment-Responsive BD

Neuropsychology Evaluation OTHER

The neuropsychology evaluation will measure verbal learning/memory, attention/working memory, psychomotor speed, verbal fluency/processing speed, and executive function

Treatment-Refractory BD; Treatment-Responsive BD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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
• Male or female ≥18 years of age
• Capable of understanding/complying with protocol requirements

Sponsors & Collaborators

• Jennifer Sweet: lead
• National Institute of Mental Health (NIMH): collaborator
• University Hospitals Cleveland Medical Center: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Jennifer Sweet, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 11, 2022
• Study Start: October 15, 2020
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: October 9, 2025

Record last verified: 2025-10

Locations

US (1)