Depression and Anxiety Trial, Recruiting NCT05295888 Sponsor: Unity Health Toronto Condition: Depression and Anxiety
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Depression and Anxiety Trial, Recruiting

NCT05295888
Recruiting Not Applicable

Who may 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 might be able to join this trial:

  • People who are willing and able to give written consent before any study activities begin
  • People who are being treated as outpatients (not currently admitted to a hospital)
  • People who have been diagnosed with major depressive disorder (a serious form of depression) and are currently experiencing a depressive episode, without any symptoms of psychosis, as confirmed by a structured interview at screening
  • People aged 18 to 65 years old at the time of screening
  • People whose depression is rated as moderate to severe based on a standard depression rating scale (a score of 20 or higher on the MADRS) at screening
  • People who have not started or increased any psychiatric medications in the 4 weeks before screening
  • People who are able to follow the treatment schedule required by the study
  • People who pass a specific adult safety questionnaire related to the treatment being studied (confirm with trial site)
  • People who the study investigators believe can understand and follow the study requirements

Who may not be able to join:

  • People who currently have a serious alcohol or drug use disorder, are experiencing withdrawal symptoms, or have completed a detox program within the past 3 months
  • People who have a major unstable physical illness, active hepatitis B, hepatitis C, HIV, active COVID-19, a cardiac pacemaker, or an implanted medication pump
  • People who have active thoughts of suicide, as identified through specific screening questionnaires at the time of screening
  • People who have a current clinical diagnosis of autism, dementia, or intellectual disability
  • People who are taking medications that are not permitted under the study protocol (the study doctor will review all medications)
  • People who are pregnant or breastfeeding
  • People who have ever been diagnosed with bipolar disorder (type I or II), depression with psychotic features, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or who currently have psychotic symptoms
  • People who have obsessive-compulsive disorder or post-traumatic stress disorder (current or within the past year) that is considered by a study investigator to be more impairing than their depression
  • People who have a personality disorder that is considered by a study investigator to be more impairing than their depression
  • People who have previously received the specific treatment being studied in this trial (confirm with trial site for details), as this could affect the blinding of the study
  • People who have a significant neurological condition, including but not limited to: a history of seizures (except those caused by electroconvulsive therapy or childhood febrile seizures), a brain lesion, cerebral aneurysm, Parkinson's disease, Huntington's disease, multiple sclerosis, a serious head injury involving more than 5 minutes of unconsciousness, or poorly controlled migraines requiring ongoing preventive medication
  • People who have a metal implant inside or near their head (such as aneurysm clips, brain stimulators, cochlear implants, or electrodes), or any other metal object near the head that cannot be safely removed
  • People who are currently in psychotherapy but have not been in a stable and consistent therapy arrangement for at least 3 months before joining, or who expect their therapy to change during the study
  • People who have a significant abnormal result on laboratory tests, in the opinion of the study doctors
  • People who are currently taking medications that may reduce the effectiveness of the study treatment (confirm with trial site)
  • People who have a significant hearing impairment that cannot be corrected and would prevent them from participating in interviews
  • People who have an unstable health condition that, in the opinion of the study investigators, could be negatively affected by the study treatment — for example, poorly controlled diabetes, high blood pressure, or unstable angina
  • People who have an untreated thyroid condition, or who take thyroid medication but have not been on a stable dose for at least 30 days before enrolling
  • People who have any other condition that, in the opinion of the study investigators, could affect their ability to complete the study
  • People whose hairstyle or head covering at the time of the treatment sessions would prevent proper contact between the electrodes and the scalp
  • People who have any reason they cannot safely receive the study treatment or undergo an MRI scan — for example, a hip circumference greater than 180 cm or metal in the body

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 9 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.

Contact this trial

Principal Investigator: Venkat Bhat, MD MSc, Unity Health Toronto

Phone: 416-360-4000

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Unity Health Toronto
Registry
ClinicalTrials.gov
Start date
15 May 2025
Est. completion
1 December 2027

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Neuroimaging - Signal variance; Neuroimaging - Functional connectivity; Neuroimaging - Anatomical connectivity; Neuroimaging - Perfusion metrics

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: 9 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