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Rostral Dorsal Cingulum Bundle Connectivity in Patients With Bipolar Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02655978
Recruitment Status : Suspended (Funding)
First Posted : January 14, 2016
Last Update Posted : April 2, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Jennifer Sweet, MD, 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.

Condition or disease Intervention/treatment
Bipolar Disorder Other: Magnetic Resonance Imaging

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Study Type : Observational
Estimated Enrollment : 75 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 : January 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Group/Cohort 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



Primary Outcome Measures :
  1. Differences in connectivity in the rostral dorsal CB in patients with BDI or or BDII compared to matched controls [ Time Frame: Day 1 ]
    The imaging visit will consist of an MRI with diffusion-weighted imaging (DWI) sequences



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

    a. Inclusion Criteria for Group 1:

    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)

    b. Exclusion Criteria for Group 1:

    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.

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

    a. Inclusion Criteria for Group 2:

    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. 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

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

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

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

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

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

    b. Exclusion Criteria for Group 2:

    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. 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)

    v. Meets criteria for antisocial personality disorder

    vi. Meets criteria for having borderline personality disorder

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

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

    ix. 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

    x. Currently pregnant or planning to become pregnant

    xi. Any other contraindications to the brain imaging procedures.

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

    a. Inclusion Criteria for Group 3:

    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. 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)

    v. 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

    vi. 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

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

    viii. 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)

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

    b. Exclusion Criteria for Group 3:

    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. 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)

    v. Meets criteria for antisocial personality disorder

    vi. Meets criteria for having borderline personality disorder

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

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

    ix. 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

    x. 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

    xi. Currently pregnant or planning to become pregnant

    xii. Any other contraindications to the brain imaging procedures.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02655978


Locations
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United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Jennifer A Sweet, MD University Hospitals Cleveland Medical Center
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Responsible Party: Jennifer Sweet, MD, Neurosurgeon, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT02655978    
Other Study ID Numbers: 02-15-35
KL2TR000440 ( U.S. NIH Grant/Contract )
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders