Brain Circuitry Analysis in Bipolar Disorder

Suspended

• Conditions: Bipolar Disorder
• Interventions: Other: Magnetic Resonance Imaging; Other: Psychiatric testing; Other: Eye-Tracking; Other: Neuropsychology Evaluation

• Registration Number: NCT05186077
• Lead Sponsor: Jennifer Sweet

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-15
• Study First Submitted: 2021-12-23
• Study First Submitted QC: 2021-12-23
• Study First Posted: 2022-01-11
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment-Responsive BD	Magnetic Resonance Imaging	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
Treatment-Responsive BD	Psychiatric testing	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
Healthy Controls	Magnetic Resonance Imaging	These participants will not have any psychiatric disorder as assessed by a structured clinical interview for psychiatric disorders.
Treatment-Responsive BD	Eye-Tracking	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
Treatment-Responsive BD	Neuropsychology Evaluation	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
Treatment-Refractory BD	Magnetic Resonance Imaging	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.
Treatment-Refractory BD	Psychiatric testing	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.
Treatment-Refractory BD	Neuropsychology Evaluation	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.
Treatment-Refractory BD	Eye-Tracking	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.

Primary Outcome Measures

Name	Time	Method
Characterize white matter (WM) connectivity with DWT to identify an anatomical substrate for BD that has future potential as a therapeutic target	Day 1	The imaging visit will consist of an MRI with diffusion-weighted imaging (DWI) sequences

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States