Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine | 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). |
| |
| SPRAVATO | 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). |
| |
| TMS | 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). |
| |
| Antidepressants | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fNIRS measurement | Other | Kernel Flow2 measurements. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-Ã…sberg 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. |
Not provided
Inclusion Criteria:
Ketamine cohort
SPRAVATO cohort
TMS cohort
Antidepressants cohort
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:
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)
Not provided
Not provided
Adult participants seeking treatment for depression at a participating clinic/study site. Separate cohorts of participants will be enrolled depending on the treatment they have been prescribed. 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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Katherine Perdue, PhD | Kernel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BrainHealth Solutions | Costa Mesa | California | 92626 | United States | ||
| Kadima Neuropsychiatry Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| La Jolla |
| California |
| 92037 |
| United States |
| Kaizen Brain Center, LLC | La Jolla | California | 92037 | United States |
| Bespoke Treatment | Los Angeles | California | 90012 | United States |
| UCLA TMS | Los Angeles | California | 90024 | United States |
| Bespoke Treatment | Los Angeles | California | 90025 | United States |
| Acacia Clinics | Sunnyvale | California | 94087 | United States |
| Metro Psychiatry Inc. | Columbus | Ohio | 43215 | United States |
| Seattle Neuropsychiatric Treatment Center | Bellevue | Washington | 98004 | United States |
| Seattle Neuropsychiatric Treatment Center | Seattle | Washington | 98104 | United States |
| ID | Term |
|---|---|
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided