NCT02655978

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 14, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

3.8 years

First QC Date

January 6, 2016

Last Update Submit

November 10, 2020

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

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

    The imaging visit will consist of an MRI with diffusion-weighted imaging (DWI) sequences

    Day 1

Study Arms (3)

Healthy Volunteers

These participants will not have any psychiatric disorder as assessed by a structured clinical interview for psychiatric disorders.

Other: Magnetic Resonance Imaging

Medically 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

Treatment-Refractory BD

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).

Other: Magnetic Resonance Imaging

Interventions

Magnetic Resonance ImagingOTHER
Healthy VolunteersMedically Treatment-Responsive BDTreatment-Refractory BD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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 not qualify if:

  • i. Male or female, age 18 or older
  • ii. In the opinion of the investigator, capable of understanding and complying with protocol requirements
  • iii. In the opinion of the investigator, has the competency to understand and sign the informed consent
  • iv. Physically healthy
  • v. Without any current and/or lifetime psychiatric disorder assessed with a Structured Clinical Interview for psychiatric Disorders, including the Mini International Neuropsychiatric Interview (MINI)
  • i. Significant structural brain lesion identified (e.g. infarct, hemorrhage, tumor, multiple sclerosis)
  • ii. Progressive neurological disease such as neurodegenerative disease
  • iii. Preexisting implanted electrical device (such as pacemaker or cardiac defibrillator)
  • iv. Any psychiatric disorder including any severe personality disorder
  • v. Currently pregnant or planning to become pregnant
  • vi. Any other contraindications to the brain imaging procedures.
  • vii. Tests positive for illegal substances or prescription medications for which they do not have a valid prescription
  • viii. Currently taking any steroids, stimulants, or opioid pain killers.
  • ix. Currently experiencing nicotine dependence or any smoking of cigarettes or use of other nicotine containing products within a week before the imaging visit.
  • i. Male or female, age 18 or older
  • +38 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Jennifer A 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
PRINCIPAL INVESTIGATOR
PI Title
Neurosurgeon

Study Record Dates

First Submitted

January 6, 2016

First Posted

January 14, 2016

Study Start

January 1, 2016

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

November 12, 2020

Record last verified: 2020-11

Locations

US(1)