Depression, Major Depressive Disorder
Conditions
Keywords
functional Near Infrared Spectroscopy (fNIRS), Ketamine, SPRAVATO, TMS, Antidepressants
Brief summary
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.
Interventions
OTHERfNIRS measurement
Kernel Flow2 measurements.
Sponsors
Kernel
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Ketamine cohort * Adult between the ages of 18 - 65, inclusive at time of enrollment * Primary diagnosis of MDD as defined by DSM-5 * Determined by clinic to be eligible for ketamine treatment and agrees to receive ketamine treatment * Agrees to start ketamine treatment in conjunction with study participation to capture pre-treatment measurements accurately * Has not received a ketamine treatment course in the past 12 months * Has not received a TMS treatment course in the past 3 months * Ability to consent for themselves * Fluency in English (speaking and reading) SPRAVATO cohort * Adult between the ages of 18 - 75, inclusive at time of enrollment * Primary diagnosis of MDD as defined by DSM-5 * Determined by clinic to be eligible for SPRAVATO treatment and agrees to receive SPRAVATO treatment * Agrees to start SPRAVATO treatment in conjunction with study participation to capture pre-treatment measurements accurately * Has not received a ketamine or SPRAVATO treatment course in the past 12 months * Has not received a TMS treatment course in the past 3 months * Ability to consent for themselves * Fluency in English (speaking and reading) TMS cohort * Adult between the ages of 18 - 65, inclusive at time of enrollment * Primary diagnosis of MDD as defined by DSM-5 * Determined by clinic to be eligible for TMS treatment and agrees to receive TMS treatment * Agrees to start TMS treatment in conjunction with study participation to capture pre-treatment measurements accurately * Has not received a TMS treatment course in the past 12 months * Has not received a ketamine or SPRAVATO treatment course within the last 3 months * Ability to consent for themselves * Fluency in English (speaking and reading) Antidepressants cohort * Adult between the ages of 18 - 65, inclusive at time of enrollment * Primary diagnosis of MDD as defined by DSM-5 * Determined by clinic to be eligible for antidepressant treatment and agrees to receive antidepressant treatment * Agrees to start antidepressant treatment in conjunction with study participation to capture pre-treatment measurements accurately * Has not taken antidepressants in the past 3 months * Has not received a TMS, SPRAVATO, or ketamine treatment course in the past 3 months * Ability to consent for themselves * Fluency in English (speaking and reading)
Exclusion criteria
* Is or may be pregnant (for participant of childbearing potential \[POCBP\]), even if they have been cleared to receive the depression treatment * Unable or unwilling to wear the TD-fNIRS headset * Has had ECT in the past 3 months * Major visual or auditory deficits that would prevent study task completion * Hospitalizations and/or unstable health/medical condition/treatment in the last 30 days * Major medical illnesses and psychiatric conditions including: * Alzheimer's/Mild Cognitive Impairment * Parkinson's disease * Motor neuron diseases * Multiple Sclerosis * Brain Tumor * Stroke * Encephalitis * Meningitis * Epilepsy * TBI with serious results (coma, unconscious for \>2 hrs, or skull fracture) * Current serious psychiatric conditions (bipolar disorder, schizophrenia, or psychosis) * Any other clinically significant medical condition or circumstance that, in the opinion of the Investigator, could affect patient safety, preclude evaluation of response, interfere with the ability to comply with study procedures, or prohibit completion of the study * Not an appropriate candidate for the study in the judgment of the investigator(s)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain hemodynamic activity with TD-fNIRS | 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. |
| Optical properties of the brain with TD-fNIRS | Approximately 30 minutes during each study visit | This measures how much light is absorbed at different points on the head. |
| Physiological features with TD-fNIRS | Approximately 30 minutes during each study visit | This includes cardiac measures, such as heart rate (HR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Snaith-Hamilton Pleasure Scale (SHAPS) | 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. |
| Montgomery-Åsberg Depression Rating Scale (MADRS) | At baseline and closeout, up to 3 months | Clinician-rated measure of depressive severity. |
| Revised Mystical Experience Questionnaire (RMEQ) | 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. |
| World Health Organization Quality of Life (WHOQOL-BREF) | 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. |
| Patient Health Questionnaire (PHQ-9) | 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. |
| General Anxiety Disorder (GAD-7) | At baseline and closeout, up to 3 months | 7-item self-report measure used to assess participant anxiety. |
Countries
United States
Outcome results
None listed