Prediction of REsponse to Depression Interventions Using Clinical and TD-fNIRS Measurements
Part of paid clinical trials in Costa Mesa, California.
- Sponsor
- Kernel
- Study ID
- NCT06002100
- Status
- Enrolling By Invitation
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- fNIRS measurement — OTHERKernel Flow2 measurements.
Study Details
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.
Key Dates
- Start date
- Aug 14, 2023
- Status verified
- Dec 2025
- Primary completion
- Aug 31, 2026
- Completion
- Aug 31, 2026
Study Design
- Enrollment
- 540 participants (estimated)
Arms
- Arm: KetamineAdult 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).
- Arm: SPRAVATOAdult 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).
- Arm: TMSAdult 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).
- Arm: AntidepressantsAdult 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 Measure
Brain hemodynamic activity with TD-fNIRS [ Time Frame: Approximately 30 minutes during each study visit ]
Locations (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| BrainHealth Solutions | Costa Mesa | California | 92626 | - |
| Kadima Neuropsychiatry Institute | La Jolla | California | 92037 | - |
| Kaizen Brain Center, LLC | La Jolla | California | 92037 | - |
| Bespoke Treatment | Los Angeles | California | 90012 | - |
| Bespoke Treatment | Los Angeles | California | 90025 | - |
| UCLA TMS | Los Angeles | California | 90024 | - |
| Acacia Clinics | Sunnyvale | California | 94087 | - |
| Metro Psychiatry Inc. | Columbus | Ohio | 43215 | - |
| Seattle Neuropsychiatric Treatment Center | Bellevue | Washington | 98004 | - |
| Seattle Neuropsychiatric Treatment Center | Seattle | Washington | 98104 | - |
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