- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02655978
Rostral Dorsal Cingulum Bundle Connectivity in Patients With Bipolar Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ohio
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Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
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.
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Healthy Volunteers
These participants will not have any psychiatric disorder as assessed by a structured clinical interview for psychiatric disorders.
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|
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
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences in connectivity in the rostral dorsal CB in patients with BDI or or BDII compared to matched controls
Time Frame: Day 1
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The imaging visit will consist of an MRI with diffusion-weighted imaging (DWI) sequences
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Day 1
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jennifer A Sweet, MD, University Hospitals Cleveland Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02-15-35
- KL2TR000440 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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