Rostral Dorsal Cingulum Bundle Connectivity in Patients With Bipolar Disorder

Completed

• Conditions: Bipolar Disorder
• Interventions: Other: Magnetic Resonance Imaging

• Registration Number: NCT02655978
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief Summary

The overall goal of this study is to employ diffusion-weighted imaging (DWI) and tractography to investigate differences in connectivity in the rostral dorsal cingulum bundle (CB) in patients with bipolar disorder type I (BDI) or bipolar type II (BDII) compared to matched controls, and to utilize this information to determine if high-frequency deep brain stimulation (DBS) of the rostral dorsal CB has realistic potential as a therapy for producing mood stabilization in patients with BDI or BDII.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-06
• Study First Submitted QC: 2016-01-12
• Study First Posted: 2016-01-14
• Primary Completion: 2019-10
• Study Completion: 2019-10
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-10
• Last Update Posted: 2020-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	Magnetic Resonance Imaging	These participants will not have any psychiatric disorder as assessed by a structured clinical interview for psychiatric disorders.
Medically 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-Refractory BD	Magnetic Resonance Imaging	This group will be composed of participants who have BDI or BDII, are currently depressed with their current episode lasting at least 12 months and not responding to 4 adequate evidence-based treatments for BDI or BDII and who have failed, been intolerant to, or were unwilling to try electroconvulsive therapy (ECT).

Primary Outcome Measures

Name	Time	Method
Differences in connectivity in the rostral dorsal CB in patients with BDI or or BDII compared to matched controls	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