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Rostral Dorsal Cingulum Bundle Connectivity in Patients With Bipolar Disorder

Sponsor
University Hospitals Cleveland Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02655978
Collaborator
National Institutes of Health (NIH) (NIH)
45
Enrollment
1
Location
45
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Magnetic Resonance Imaging

Study Design

Study Type:
Observational
Actual Enrollment :
45 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Rostral Dorsal Cingulum Bundle Connectivity in Patients With Bipolar Disorder
Actual Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Oct 1, 2019
Actual Study Completion Date :
Oct 1, 2019

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
  1. Inclusion and Exclusion Criteria for Group 1: Healthy Volunteers

  1. Inclusion Criteria for Group 1:

  2. Male or female, age 18 or older

  1. In the opinion of the investigator, capable of understanding and complying with protocol requirements

  2. In the opinion of the investigator, has the competency to understand and sign the informed consent

  3. Physically healthy

  4. Without any current and/or lifetime psychiatric disorder assessed with a Structured Clinical Interview for psychiatric Disorders, including the Mini International Neuropsychiatric Interview (MINI)

  1. Exclusion Criteria for Group 1:

  2. Significant structural brain lesion identified (e.g. infarct, hemorrhage, tumor, multiple sclerosis)

  1. Progressive neurological disease such as neurodegenerative disease

  2. Preexisting implanted electrical device (such as pacemaker or cardiac defibrillator)

  3. Any psychiatric disorder including any severe personality disorder

  4. Currently pregnant or planning to become pregnant

  5. Any other contraindications to the brain imaging procedures.

  6. Tests positive for illegal substances or prescription medications for which they do not have a valid prescription

  7. Currently taking any steroids, stimulants, or opioid pain killers.

  8. Currently experiencing nicotine dependence or any smoking of cigarettes or use of other nicotine containing products within a week before the imaging visit.

  1. Inclusion and Exclusion Criteria for Group 2: Medically Treatment-Responsive Bipolar Disorder

  1. Inclusion Criteria for Group 2:

  2. Male or female, age 18 or older

  1. In the opinion of the investigator, capable of understanding and complying with protocol requirements

  2. In the opinion of the investigator, has the competency to understand and sign the informed consent

  3. Meets diagnostic criteria for BDI or BDII according to the DSM-V criteria, as confirmed by a systematic clinical interview and the administration of the MINI

  4. A recent episode of depression, currently in remission with evidence-based treatments for bipolar disorder

  5. Montgomery-Asberg Depression Rating Scale (MADRS) total score ≤ 10

  6. Young Mania Rating Scale (YMRS, Young et al 1988) total score ≤ 8

  7. Global Clinical Impression-Severity for Bipolar Disorder (CGI-S-BD) ≤ 2

  8. Subject is compliant with taking medication per the investigator's discretion

  1. Exclusion Criteria for Group 2:

  2. Significant structural brain lesion identified (e.g. infarct, hemorrhage, tumor, multiple sclerosis)

  1. Progressive neurological disease such as neurodegenerative disease

  2. Preexisting implanted electrical device (such as pacemaker or cardiac defibrillator)

  3. Contribution of any co-occurring psychiatric comorbidity that is disproportionate to the contribution of BDI or BDII, such as severe obsessive-compulsive disorder (OCD) or post-traumatic stress disorder (PTSD)

  4. Meets criteria for antisocial personality disorder

  5. Meets criteria for having borderline personality disorder

  6. There will be no exclusions based on prescribed CNS-active medications

  7. Tests positive for illegal substances or prescription medications for which they do not have a valid prescription

  8. Meets DSM-V criteria for any alcohol and/or drug use disorder within the last 6 months, excluding the use of caffeine and/or nicotine

  9. Currently pregnant or planning to become pregnant

  10. Any other contraindications to the brain imaging procedures.

  1. Inclusion and Exclusion Criteria for Group 3: Treatment-Refractory Bipolar Disorder

  1. Inclusion Criteria for Group 3:

  2. Male or female, age 18 or older

  1. In the opinion of the investigator, capable of understanding and complying with protocol requirements

  2. In the opinion of the investigator, has the competency to understand and sign the informed consent

  3. Meets diagnostic criteria for BDI or BDII, currently depressed, at least moderately severe with or without psychotic features, according to the DSM-V criteria, as confirmed by a systematic clinical interview and the administration of the Structured Clinical Interview for Psychiatric Disorders, including the Mini International Neuropsychiatric Interview (MINI)

  4. Current episode lasting at least 6 months and not responding to 2 adequate evidence-based treatments for BDI or BDII assessed with the assistance of Modified Antidepressant Treatment History Form (MATHF) and verified through medical records if possible

  5. If a subject has refused treatment with a particular FDA-approved mood stabilizer due to reasons of unacceptable side effects (such as weight gain, etc.), their wishes will be respected

  6. Depression severity should be measured with Montgomery-Asberg Depression Rating Scale (MADRS). A MADRS total score ≥ 20 is required at Screening Visit/Baseline Evaluation.

  7. Has experienced marked impairment as documented by a score consistent with severe impairment (7 or more on at least one of the three subscales of the Sheehan Disability Scale (SDS), which includes an assessment of work-life, family-life, and social life (no/mild impairment 0-3, moderate impairment 4-6, severe impairment 7-10)

  8. Bipolar disorder and current depressive episode as the primary source of the patient's disability, according to both the subject and the psychiatrist

  1. Exclusion Criteria for Group 3:

  2. Significant structural brain lesion identified (e.g. infarct, hemorrhage, tumor, multiple sclerosis)

  1. Progressive neurological disease such as neurodegenerative disease

  2. Preexisting implanted electrical device (such as pacemaker or cardiac defibrillator)

  3. Contribution of any co-occurring psychiatric comorbidity that disproportionate to the contribution of BDI or BDII, such as severe obsessive-compulsive disorder (OCD) or post-traumatic stress disorder (PTSD)

  4. Meets criteria for antisocial personality disorder

  5. Meets criteria for having borderline personality disorder

  6. There will be no exclusions based on prescribed CNS-active medications

  7. Tests positive for illegal substances or prescription medications for which they do not have a valid prescription

  8. Meets DSM-V criteria for any alcohol and/or drug use disorder within the last 6 months, excluding the use of caffeine and/or nicotine

  9. Active suicidal ideation with a plan or intent, a suicide attempt within past 6 months or more than 2 suicide attempts within the past 2 years

  10. Currently pregnant or planning to become pregnant

  11. Any other contraindications to the brain imaging procedures.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106

Sponsors and Collaborators

  • University Hospitals Cleveland Medical Center
  • National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Jennifer A Sweet, MD, University Hospitals Cleveland Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jennifer Sweet, MD, Neurosurgeon, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier:
NCT02655978
Other Study ID Numbers:
  • 02-15-35
  • KL2TR000440
First Posted:
Jan 14, 2016
Last Update Posted:
Nov 12, 2020
Last Verified:
Nov 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Bipolar Disorder

Study Results

No Results Posted as of Nov 12, 2020