Prediction of REsponse to Depression... — Clinical Trial Details

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

experimental

Participants starting ketamine treatment; fNIRS measured at pre-treatment, early-treatment, and post-treatment visits.

Interventions

Compound
via Other• measurements
Kernel Flow2 fNIRS measurement at pre-treatment, early-treatment, and post-treatment visits.

SPRAVATO

experimental

Participants starting SPRAVATO (esketamine) treatment; fNIRS measured at pre-treatment, early-treatment, and post-treatment visits.

Interventions

Participants

Ages

18 – 75

Sexes

Male & Female

BMI

Psychosis History

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)

Company

Product

Legal

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

Detailed Description

Study Arms & Interventions

Ketamine

Interventions

SPRAVATO

Interventions

Locations

TMS

Interventions

Antidepressants

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators