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Bipolar DisorderNCT02655978

Rostral Dorsal Cingulum Bundle Connectivity in Patients With Bipolar Disorder

An observational study of Bipolar Disorder, run by University Hospitals Cleveland Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Bipolar Disorder
What is being tested?
Magnetic Resonance Imaging
How many people
45 participants
Where
1 siteUnited States
Study dates
Jan 2016to Oct 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

  1. Inclusion and Exclusion Criteria for Group 1: Healthy Volunteers
  2. Inclusion Criteria for Group 1:
  3. 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
  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)
  5. Exclusion Criteria for Group 1:
  6. 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
  7. 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.
  8. Inclusion and Exclusion Criteria for Group 2: Medically Treatment-Responsive Bipolar Disorder
  9. Inclusion Criteria for Group 2:
  10. 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
  11. 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
  12. Exclusion Criteria for Group 2:
  13. 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)
  14. 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
  15. Currently pregnant or planning to become pregnant xi. Any other contraindications to the brain imaging procedures.
  16. Inclusion and Exclusion Criteria for Group 3: Treatment-Refractory Bipolar Disorder
  17. Inclusion Criteria for Group 3:
  18. 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)
  19. 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
  20. Exclusion Criteria for Group 3:
  21. 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)
  22. 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
  23. 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

Other trials in United States

About this study

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.

Being tested
Magnetic Resonance Imaging
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnetic Resonance ImagingOther

Study groups in NCT02655978
Study groupRoleWhat they receive
Healthy VolunteersThese participants will not have any psychiatric disorder as assessed by a structured clinical interview for psychiatric disorders.
Receives: Other: Magnetic Resonance Imaging
Medically Treatment-Responsive BDThis 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
Receives: Other: Magnetic Resonance Imaging
Treatment-Refractory BDThis 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).
Receives: Other: Magnetic Resonance Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionOct 2019
  4. Study completionOct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02655978
Sponsor's protocol ID
02-15-35
Other IDs
KL2TR000440
Status last verified
Nov 2020
First submitted
6 Jan 2016
Last updated
12 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Bipolar Disorder, run by University Hospitals Cleveland Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences in connectivity in the rostral dorsal CB in patients with BDI or or BDII compared to matched controls (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02655978.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.

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