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

Depression Clinical Trial

— PREDICT  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06002100
• Other study ID #: KER2023-2-PREDICT
• Status: Enrolling by invitation
• Start date: August 14, 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Kernel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 540
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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:

• 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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Other:
• fNIRS measurement
Kernel Flow2 measurements.

Locations

Country	Name	City	State
United States	Yofi Mind Health	Agoura Hills	California
United States	Seattle Neuropsychiatric Treatment Center	Bellevue	Washington
United States	BrainHealth Solutions	Costa Mesa	California
United States	Yofi Mind Health	Encino	California
United States	Kadima Neuropsychiatry Institute	La Jolla	California
United States	Bespoke Treatment	Los Angeles	California
United States	Bespoke Treatment	Los Angeles	California
United States	ATP Clinical Research	Orange	California
United States	Seattle Neuropsychiatric Treatment Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Kernel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Physiological features with TD-fNIRS	This includes cardiac measures, such as heart rate (HR).	Approximately 30 minutes during each study visit
Primary	Physiological features with TD-fNIRS	This includes cardiac measures, such as heart rate variability (HRV).	Approximately 30 minutes during each study visit
Secondary	Montgomery-Åsberg Depression Rating Scale (MADRS)	Clinician-rated measure of depressive severity.	At baseline and closeout, up to 3 months
Secondary	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.	From baseline to closeout, up to 3 months
Secondary	General Anxiety Disorder (GAD-7)	7-item self-report measure used to assess participant anxiety.	At baseline and closeout, up to 3 months
Secondary	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
Secondary	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
Secondary	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