fNIRS measurement
OtherKernel Flow2 measurements.
NCT Number: NCT06002100
The purpose of the current study is to perform a unified, homogeneous data collection protocol that includes a large cohort of patients undergoing different treatment options for Major Depressive Disorder (MDD) as an avenue for investigating optimal biomarkers for depression treatments on an individual patient level.
Interested in participating?
Request Info18 year–75 year
All sexes
Observational
BrainHealth Solutions, Costa Mesa, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Ketamine cohort
SPRAVATO cohort
TMS cohort
Antidepressants cohort
Exclusion criteria
Kernel Flow2 measurements.
Time frame: Approximately 30 minutes during each study visit
This includes changes in the concentration of oxygenated and deoxygenated hemoglobin as measured by the change in light absorption.
Time frame: Approximately 30 minutes during each study visit
This measures how much light is absorbed at different points on the head.
Time frame: Approximately 30 minutes during each study visit
This includes cardiac measures, such as heart rate (HR).
Time frame: Approximately 30 minutes during each study visit
This includes cardiac measures, such as heart rate variability (HRV).
Time frame: At baseline and closeout, up to 3 months
Clinician-rated measure of depressive severity.
Time frame: From baseline to closeout, up to 3 months
9-item self-report that has been validated as a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression.
Time frame: At baseline and closeout, up to 3 months
7-item self-report measure used to assess participant anxiety.
Time frame: At baseline and closeout, up to 3 months
14-item self-administered questionnaire measuring anhedonia (inability to feel pleasure) through four domains of pleasure response: interest/pastimes, social interaction, sensory experience, and food/drink.
Time frame: At baseline and closeout, up to 3 months
26-item self-report which aims to assess an individual's quality of life. The scale was developed with a cross-cultural approach and covers domains including physical, psychological, social relationships, and environment.
Time frame: Visit 2, within approximately 7 days of baseline
30-item self-report which provides scale scores for four domains: mystical experience, positive mood, transcendence of time and space, and ineffability. Ketamine and SPRAVATO cohorts only.
Kernel
Industry
PREDICT: Prediction of REsponse to Depression Interventions Using Clinical and TD-fNIRS Measurements
Acronym: PREDICT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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