Depression and Anxiety Trial, By Invitation NCT06002100 Sponsor: Kernel Condition: Depression and Anxiety
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Depression and Anxiety Trial, By Invitation

NCT06002100
By Invitation Not Applicable

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

Ketamine group:

  • Adults aged 18 to 65 years old at the time of joining the study
  • People with a primary diagnosis of major depressive disorder (MDD), as defined by standard psychiatric guidelines (DSM-5)
  • People whom the clinic has determined are eligible for ketamine treatment and who agree to receive it
  • People who agree to start ketamine treatment at the same time as joining the study, so that measurements can be taken before treatment begins
  • People who have not received a course of ketamine treatment in the past 12 months
  • People who have not received a course of TMS (a type of brain stimulation therapy) in the past 3 months
  • People who are able to give their own consent to participate
  • People who can speak and read English fluently

SPRAVATO (esketamine nasal spray) group:

  • Adults aged 18 to 75 years old at the time of joining the study
  • People with a primary diagnosis of major depressive disorder (MDD), as defined by standard psychiatric guidelines (DSM-5)
  • People whom the clinic has determined are eligible for SPRAVATO treatment and who agree to receive it
  • People who agree to start SPRAVATO treatment at the same time as joining the study, so that measurements can be taken before treatment begins
  • People who have not received a course of ketamine or SPRAVATO treatment in the past 12 months
  • People who have not received a course of TMS in the past 3 months
  • People who are able to give their own consent to participate
  • People who can speak and read English fluently

TMS (brain stimulation) group:

  • Adults aged 18 to 65 years old at the time of joining the study
  • People with a primary diagnosis of major depressive disorder (MDD), as defined by standard psychiatric guidelines (DSM-5)
  • People whom the clinic has determined are eligible for TMS treatment and who agree to receive it
  • People who agree to start TMS treatment at the same time as joining the study, so that measurements can be taken before treatment begins
  • People who have not received a course of TMS treatment in the past 12 months
  • People who have not received a course of ketamine or SPRAVATO treatment in the past 3 months
  • People who are able to give their own consent to participate
  • People who can speak and read English fluently

Antidepressants group:

  • Adults aged 18 to 65 years old at the time of joining the study
  • People with a primary diagnosis of major depressive disorder (MDD), as defined by standard psychiatric guidelines (DSM-5)
  • People whom the clinic has determined are eligible for antidepressant medication and who agree to receive it
  • People who agree to start antidepressant treatment at the same time as joining the study, so that measurements can be taken before treatment begins
  • People who have not taken antidepressants in the past 3 months
  • People who have not received a course of TMS, SPRAVATO, or ketamine treatment in the past 3 months
  • People who are able to give their own consent to participate
  • People who can speak and read English fluently

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who are pregnant or may be pregnant, even if they have been cleared to receive the depression treatment being studied
  • People who are unable or unwilling to wear a specialised headset used to measure brain activity during the study (TD-fNIRS headset)
  • People who have had electroconvulsive therapy (ECT) in the past 3 months
  • People with significant vision or hearing difficulties that would prevent them from completing the study tasks
  • People who have been hospitalised or have had an unstable health condition or medical treatment in the past 30 days
  • People who have been diagnosed with Alzheimer's disease or mild memory and thinking problems (Mild Cognitive Impairment)
  • People who have been diagnosed with Parkinson's disease
  • People who have been diagnosed with a motor neuron disease
  • People who have been diagnosed with Multiple Sclerosis
  • People who have a brain tumour
  • People who have had a stroke
  • People who have had encephalitis (brain inflammation)
  • People who have had meningitis (infection of the membranes around the brain)
  • People who have epilepsy
  • People who have had a serious traumatic brain injury, such as one that resulted in a coma, loss of consciousness for more than 2 hours, or a skull fracture
  • People with a current serious psychiatric condition, including bipolar disorder, schizophrenia, or psychosis
  • People with any other significant medical or health condition that, in the opinion of the study investigator, could affect safety, interfere with the study, or prevent the person from completing it
  • People whom the study investigator considers not to be a suitable candidate for the study for any other reason

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 29 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

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Trial details

Status
By Invitation
Phase
Not Applicable
Sponsor
Kernel
Registry
ClinicalTrials.gov
Start date
14 August 2023
Est. completion
1 August 2026

This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Brain hemodynamic activity with TD-fNIRS; Optical properties of the brain with TD-fNIRS; Physiological features with TD-fNIRS; Physiological features with TD-fNIRS

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 29 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov