Rostral Dorsal Cingulum Bundle Connectivity in Patients With Bipolar Disorder

NCT ID: NCT02655978

Last Updated: 2020-11-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-10-31

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.

Conditions

Bipolar Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Healthy Volunteers

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

Magnetic Resonance Imaging

Intervention Type: OTHER

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

Magnetic Resonance Imaging

Intervention Type: OTHER

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).

Magnetic Resonance Imaging

Intervention Type: OTHER

Interventions

Magnetic Resonance Imaging

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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. 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

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

Exclusion Criteria

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. 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Sweet, MD

Neurosurgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer A Sweet, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

KL2TR000440

Identifier Type: NIH

Identifier Source: secondary_id

View Link

02-15-35

Identifier Type: -

Identifier Source: org_study_id