Prediction of REsponse to Depression Interventions Using Clinical and TD-fNIRS Measurements (PREDICT)
This observational cohort study (n=540) aims to gather unified data from a large cohort of patients with Major Depressive Disorder (MDD) undergoing various treatment (including ketamine & esketamine) options to identify optimal biomarkers for depression treatments at the individual patient level.
Detailed Description
PREDICT is a prospective observational cohort collecting standardised TD-fNIRS (Kernel Flow2) and clinical data from adults starting treatment for MDD across separate cohorts: ketamine, esketamine (SPRAVATO), TMS, and antidepressant medication.
fNIRS measurements are taken at pre-treatment and at early- and post-treatment visits (timing varies by cohort). Data are observational only and will not influence clinical treatment decisions; the primary aim is to identify biomarkers predictive of individual treatment response.
Study Arms & Interventions
Ketamine
experimentalParticipants starting ketamine treatment; fNIRS measured at pre-treatment, early-treatment, and post-treatment visits.
Interventions
- Compoundvia Other• measurements
Kernel Flow2 fNIRS measurement at pre-treatment, early-treatment, and post-treatment visits.
SPRAVATO
experimentalParticipants starting SPRAVATO (esketamine) treatment; fNIRS measured at pre-treatment, early-treatment, and post-treatment visits.
Interventions
- Esketaminevia Other• measurements
Kernel Flow2 fNIRS measurement at pre-treatment, early-treatment, and post-treatment visits.
TMS
experimentalParticipants starting TMS treatment; fNIRS measured at pre-treatment, early-treatment, and post-treatment visits.
Interventions
- Compoundvia Other• measurements
Kernel Flow2 fNIRS measurement at pre-treatment, early-treatment, and post-treatment visits.
Antidepressants
experimentalParticipants starting antidepressant medication; fNIRS measured at pre-treatment and short-term efficacy visit.
Interventions
- Compoundvia Other• measurements
Kernel Flow2 fNIRS measurement at pre-treatment and short-term efficacy visit.
Participants
Inclusion Criteria
- 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
- 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)
Study Details
- StatusEnrolling by invitation
- PhasePhase NA
- Typeobservational
- DesignNon-randomized
- Target Enrollment540 participants
- TimelineStart: 2023-08-14End: 2024-12-31
- Compound
- Topic