Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
26 participants
OBSERVATIONAL
2020-10-15
2025-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Healthy Controls
These participants will not have any psychiatric disorder as assessed by a structured clinical interview for psychiatric disorders.
Magnetic Resonance Imaging
Imaging data for research purposes (high-resolution T1 structural and DWI MRI) will be acquired
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
Imaging data for research purposes (high-resolution T1 structural and DWI MRI) will be acquired
Psychiatric testing
Subjects will be evaluated using psychiatric assessments
Eye-Tracking
Eye-tracking assessments will be done to biases toward positive and negative stimuli including images of neutral, fearful/threatening, sad, and happy.
Neuropsychology Evaluation
The neuropsychology evaluation will measure verbal learning/memory, attention/working memory, psychomotor speed, verbal fluency/processing speed, and executive function
Treatment-Refractory BD
This group will be composed of participants who have BDI or BDII, are currently depressed or manic with their current episode lasting at least 6months and not responding to 2 or more adequate evidence-based treatments for BDI or BDII.
Magnetic Resonance Imaging
Imaging data for research purposes (high-resolution T1 structural and DWI MRI) will be acquired
Psychiatric testing
Subjects will be evaluated using psychiatric assessments
Eye-Tracking
Eye-tracking assessments will be done to biases toward positive and negative stimuli including images of neutral, fearful/threatening, sad, and happy.
Neuropsychology Evaluation
The neuropsychology evaluation will measure verbal learning/memory, attention/working memory, psychomotor speed, verbal fluency/processing speed, and executive function
Interventions
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Magnetic Resonance Imaging
Imaging data for research purposes (high-resolution T1 structural and DWI MRI) will be acquired
Psychiatric testing
Subjects will be evaluated using psychiatric assessments
Eye-Tracking
Eye-tracking assessments will be done to biases toward positive and negative stimuli including images of neutral, fearful/threatening, sad, and happy.
Neuropsychology Evaluation
The neuropsychology evaluation will measure verbal learning/memory, attention/working memory, psychomotor speed, verbal fluency/processing speed, and executive function
Eligibility Criteria
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Inclusion Criteria
2. Capable of understanding/complying with protocol requirements
3. Has competency to understand and sign informed consent form
4. Physically healthy with no acute medical condition and ≤3 stable, chronic medical conditions
5. Without current and/or lifetime psychiatric disorders as assessed by the Mini International Neuropsychiatric Interview for DSM-5 (MINI)
1. Male or female ≥18 years of age
2. Capable of understanding/complying with protocol requirements
3. Has competency to understand and sign informed consent form
4. Physically healthy with no acute medical condition and ≤3 stable, chronic medical conditions
5. Meets diagnostic criteria for BDI or BDII according to the DSM-5 criteria
6. Must be stable on current BD medications with no dosing changes in the last 30 days or not currently taking any BD medications.
7. Recent mood episode must currently be in remission for \> 8 weeks
8. Montgomery-Asberg Depression Rating Scale (MADRS) ≤10 total score during the psychiatric assessments portion and at the MRI visit (if repeated at MRI visit)
9. Young Mania Rating Scale (YMRS) ≤12 total score during the psychiatric assessments portion and at the MRI visit (if repeated at MRI visit)
10. Clinical Global Impression-Severity for Bipolar Disorder (CGI-S-BD) ≤2 during the psychiatric assessments visit
11. Must be adherent (≥ 80%) with BD medication(s)
1. Male or female ≥18 years of age
2. Capable of understanding/complying with protocol requirements
3. Has competency to understand and sign informed consent form
4. Physically healthy with no acute medical condition and ≤3 stable, chronic medical conditions
5. Meets diagnostic criteria for BDI or BDII according to the DSM-5 criteria
6. Must be stable on drugs, including at least 1 mood stabilizer, with no dosing changes in the last 30 days
7. GCI-S-BD \>3 at the psychiatric assessments visit
8. MADRS ≥20 total score or YMRS ≥18 total score during the psychiatric assessments portion and at the MRI visit (if repeated at MRI visit)
9. BD-associated mood episodes are primary source of disability, according to both subject and psychiatrist
10. Current depressive episode lasting ≥6 months despite ≥ 2 adequate evidence-based first-line treatment \> 8 weeks, current manic/hypomanic episode lasting ≥2 months despite ≥ 2 adequate evidence-based first-line treatment \> 4 weeks, or meeting rapid cycling criteria in last 12 months despite ≥2 evidence-based first-line treatments for BDI or BDII assessed with assistance of Modified Antidepressant Treatment History Form (MATHF)
11. Severe impairment with score of ≥7 on at least one of three subscales of Sheehan Disability Scale (SDS), which includes assessment of work-life, family-life, and social life during the psychiatric assessments portion
Exclusion Criteria
2. Significant structural brain lesion
3. Progressive neurological disease
4. Preexisting implanted electrical device
5. Currently pregnant or planning to become pregnant
6. Contraindications to MR imaging
7. Tests positive for cannabis, illegal substances, or prescription medications without valid prescription
8. Currently taking steroids, opioids, or other agents that might affect brain circuitry per research team discretion
9. Use of cigarettes or other nicotine products within 12 hours of imaging visit
10. Use of stimulants 24 hours prior MRI visit
11. Presents an immediate danger to self or others as judged by research psychiatrist
12. Has psychiatric disorder, including alcohol/drug use disorder or personality disorder
Group 2: Treatment-Responsive BDI
1. Acute medical condition or \>3 stable, chronic health conditions
2. Significant structural brain lesion
3. Progressive neurological disease
4. Preexisting implanted electrical device
5. Currently pregnant or planning to become pregnant
6. Contraindications to MR imaging
7. Tests positive for cannabis, illegal substances, or prescription medications without valid prescription
8. Currently taking steroids, opioids, or other agents that might affect brain circuitry per research team discretion
9. Use of cigarettes or other nicotine products within 12 hours of imaging visit
10. Use of stimulants within 24 hours of imaging visit
11. Presents an immediate danger to self or others as judged by research psychiatrist
12. Has had changes in medications within 30 days
13. Contribution of any co-occurring psychiatric comorbidity disproportionate to contribution of BDI or BDII
14. Meets DSM-5 criteria for current borderline or antisocial personality disorder
15. Meets DSM-5 criteria for alcohol and/or drug use disorder within 6 months, excluding caffeine and/or nicotine
Group 3: Treatment-Refractory BDI
1. Acute medical condition or \>3 stable, chronic health conditions
2. Significant structural brain lesion
3. Progressive neurological disease
4. Preexisting implanted electrical device
5. Currently pregnant or planning to become pregnant
6. Contraindications to MR imaging
7. Tests positive for cannabis, illegal substances, or prescription medications without valid prescription
8. Currently taking steroids, opioids, or other agents that might affect brain circuitry per research team discretion
9. Use of cigarettes or other nicotine products within 12 hours of imaging visit
10. Use of stimulants within 24 hours of imaging visit
11. Presents an immediate danger to self or others as judged by research psychiatrist
12. Has had changes in medications within 30 days
13. Contribution of any co-occurring psychiatric comorbidity disproportionate to contribution of BDI or BDII
14. Meets DSM-5 criteria for current borderline or antisocial personality disorder
15. Meets DSM-5 criteria for alcohol and/or drug use disorder within 6 months, excluding caffeine and/or nicotine
18 Years
ALL
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University Hospitals Cleveland Medical Center
OTHER
Jennifer Sweet
OTHER
Responsible Party
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Jennifer Sweet
Principal Investigator
Principal Investigators
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Jennifer Sweet, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center
Locations
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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STUDY20201112
Identifier Type: -
Identifier Source: org_study_id
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