Prediction of REsponse to Depression Interventions Using Clinical and TD-fNIRS Measurements
- Conditions
- DepressionMajor Depressive Disorder
- Interventions
- Other: fNIRS measurement
- Registration Number
- NCT06002100
- Lead Sponsor
- Kernel
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 540
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)
-
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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ketamine fNIRS measurement 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). TMS fNIRS measurement 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). SPRAVATO fNIRS measurement 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). Antidepressants fNIRS measurement 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).
- Primary Outcome Measures
Name Time Method Physiological features with TD-fNIRS Approximately 30 minutes during each study visit This includes cardiac measures, such as heart rate variability (HRV).
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.
- Secondary Outcome Measures
Name Time Method Montgomery-Åsberg Depression Rating Scale (MADRS) At baseline and closeout, up to 3 months Clinician-rated measure of depressive severity.
General Anxiety Disorder (GAD-7) At baseline and closeout, up to 3 months 7-item self-report measure used to assess participant anxiety.
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.
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.
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.
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.
Trial Locations
- Locations (8)
Kaizen Brain Center, LLC
🇺🇸La Jolla, California, United States
Acacia Clinics
🇺🇸Sunnyvale, California, United States
Metro Psychiatry Inc.
🇺🇸Columbus, Ohio, United States
BrainHealth Solutions
🇺🇸Costa Mesa, California, United States
Kadima Neuropsychiatry Institute
🇺🇸La Jolla, California, United States
Bespoke Treatment
🇺🇸Los Angeles, California, United States
UCLA TMS
🇺🇸Los Angeles, California, United States
Seattle Neuropsychiatric Treatment Center
🇺🇸Seattle, Washington, United States
Kaizen Brain Center, LLC🇺🇸La Jolla, California, United States