Prediction of REsponse to Depression Interventions Using Clinical and TD-fNIRS Measurements

Study Overview
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Brief Summary
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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.

Official Title
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PREDICT: Prediction of REsponse to Depression Interventions Using Clinical and TD-fNIRS Measurements

Conditions
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Depression, Major Depressive Disorder

Intervention / Treatment
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* Other: fNIRS measurement


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ketamine<br>Adult participants starting ketamine treatment for depression at a participating clinic. fNIRS measurements using Kernel Flow2 will be taken at a pre-treatment, early-treatment, and post-treatment visit. No clinical decisions will be made based on the data acquired for this study, and participation in the study has no influence on treatment decisions (including dosage form, frequency, and duration). | Other: fNIRS measurement<br>* Kernel Flow2 measurements.<br>|
| SPRAVATO<br>Adult participants starting SPRAVATO treatment for depression at a participating clinic. fNIRS measurements using Kernel Flow2 will be taken at a pre-treatment, early-treatment, and post-treatment visit. No clinical decisions will be made based on the data acquired for this study, and participation in the study has no influence on treatment decisions (including dosage form, frequency, and duration). | Other: fNIRS measurement<br>* Kernel Flow2 measurements.<br>|
| TMS<br>Adult participants starting TMS treatment for depression at a participating clinic. fNIRS measurements using Kernel Flow2 will be taken at a pre-treatment, early-treatment, and post-treatment visit. No clinical decisions will be made based on the data acquired for this study, and participation in the study has no influence on treatment decisions (including dosage form, frequency, and duration). | Other: fNIRS measurement<br>* Kernel Flow2 measurements.<br>|
| Antidepressants<br>Adult participants starting antidepressant treatment for depression at a participating clinic. fNIRS measurements using Kernel Flow2 will be taken at a pre-treatment and short-term efficacy visit. No clinical decisions will be made based on the data acquired for this study, and participation in the study has no influence on treatment decisions (including dosage form, frequency, and duration). | Other: fNIRS measurement<br>* Kernel Flow2 measurements.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain hemodynamic activity with TD-fNIRS | This includes changes in the concentration of oxygenated and deoxygenated hemoglobin as measured by the change in light absorption. | Approximately 30 minutes during each study visit | 
| Optical properties of the brain with TD-fNIRS | This measures how much light is absorbed at different points on the head. | Approximately 30 minutes during each study visit | 
| Physiological features with TD-fNIRS | This includes cardiac measures, such as heart rate (HR). | Approximately 30 minutes during each study visit | 
| Physiological features with TD-fNIRS | This includes cardiac measures, such as heart rate variability (HRV). | Approximately 30 minutes during each study visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Åsberg Depression Rating Scale (MADRS) | Clinician-rated measure of depressive severity. | At baseline and closeout, up to 3 months | 
| Patient Health Questionnaire (PHQ-9) | 9-item self-report that has been validated as a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression. | From baseline to closeout, up to 3 months | 
| General Anxiety Disorder (GAD-7) | 7-item self-report measure used to assess participant anxiety. | At baseline and closeout, up to 3 months | 
| Snaith-Hamilton Pleasure Scale (SHAPS) | 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. | At baseline and closeout, up to 3 months | 
| World Health Organization Quality of Life (WHOQOL-BREF) | 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. | At baseline and closeout, up to 3 months | 
| Revised Mystical Experience Questionnaire (RMEQ) | 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. | Visit 2, within approximately 7 days of baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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functional Near Infrared Spectroscopy (fNIRS), Ketamine, SPRAVATO, TMS, Antidepressants