NCT06897670 Identifying Cerebral Hemodynamic Patterns in Mood Disorders and Mild Cognitive Impairment: A Functional Near-Infrared Spectroscopy (fNIRS) Study
| NCT ID | NCT06897670 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Major Depressive Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-03-26 |
| Primary Completion | 2028-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-03-26 with a primary completion date of 2028-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this research is to measure brain activity in individuals with mood disorders and memory problems using a simple, safe, and noninvasive method called functional near-infrared spectroscopy (fNIRS). By comparing brain activity across different groups and relating it to symptom severity, this study aims to improve our understanding of how these conditions affect the brain.
Eligibility Criteria
Inclusion Criteria General Inclusion Criteria (across all diagnostic groups): * 18 years and older * Ability to provide written informed consent * Adequate cognitive and language abilities to understand and complete study tasks, including clinical assessments and fNIRS procedures * Confirmed clinical diagnosis of major depressive disorder, bipolar disorder, or mild cognitive impairment (MCI) * Stable psychiatric or cognitive condition, without acute episodes requiring immediate intervention Specific Inclusion Criteria (for diagnostic groups): * Healthy control o No past or current psychiatric or cognitive disorder * Major depressive disorder (MDD): * Diagnosis of major depressive disorder, confirmed through clinical evaluation. * No history of bipolar disorder or psychotic symptoms. * Bipolar disorder: o Diagnosis of bipolar disorder I or II, confirmed through clinical evaluation. * Mild Cognitive Impairment (MCI): * Pre-existing clinical diagnosis of mild cognitive impairment, supported by neuropsychological testing and/or MRI, PET scan data. * No history of major psychiatric disorders, such as major depression, bipolar disorder or schizophrenia. Exclusion Criteria General Exclusion Criteria (across all diagnostic groups): * Active primary psychotic or substance use disorders (except nicotine dependence) within the past year * Any severe or unstable medical condition that could interfere with participation or data collection * Any active neurological condition (including seizure disorder, traumatic brain injury, stroke) that could affect cognitive functioning or brain imaging results * Inability to comply with study procedures, including cognitive testing, fNIRS assessment, or other assessments required by the protocol * Pregnant women will be excluded due to potential physiological changes that could affect study outcomes Specific Exclusion Criteria (for diagnostic groups): * Healthy control o Any past or current psychiatric or cognitive disorder * Major depressive disorder (MDD): * Diagnosis of bipolar disorder or schizophrenia. * Brain stimulation therapy within the past 3 months. * Bipolar disorder: o Diagnosis of schizophrenia or schizoaffective disorder. * Mild Cognitive Impairment (MCI): * Diagnosis of dementia. * Significant cognitive impairment preventing understanding or completion of study tasks.
Contact & Investigator
Maria I. Lapid, M.D.
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT06897670 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06897670 currently recruiting?
Yes, NCT06897670 is actively recruiting participants. Contact the research team at Williams.Sarah2@mayo.edu for enrollment information.
Where is the NCT06897670 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT06897670 clinical trial?
NCT06897670 is sponsored by Mayo Clinic. The principal investigator is Maria I. Lapid, M.D. at Mayo Clinic. The trial plans to enroll 200 participants.