Clinical trial for Treatment Resistant Depression
Official title InTRavenous kEtAmine and immerSive virtUal Reality to Treat dEpression
ClinicalTrials.gov ID: NCT06781697
What this study is testing
What is Ketamine?
Ketamine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for treatment resistant depression.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Depression is a common condition, with serious negative effects on the health and quality of life of those affected. While there are currently various medications which attempt to treat depression, they often take a long time to begin to work and do not work at all for many people.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18, able to provide informed consent
- Patient diagnosed with treatment-resistant depression
- Outpatient recommended and approved by psychiatrist for ketamine treatment
- Patients who are on IV ketamine and requiring at least 4 treatments of IV ketamine per course (prescribed by their physiatrist)
- Cognitively alert, oriented, and able to watch immersive content and respond to questions
You likely can't join if
- History of psychosis/comorbid psychiatric disorders/psychotic depression/dissociative syndromes, significant personality disorder, as clinically...
- Using non-prescribed substance (e.g., cannabis) or alcohol use within the preceding 48 hours of treatment
- History of substance misuse and/or dependence, including chronic alcohol abuse
- Previous ketamine use
- Acute dementia/delirium
- Acute risk of suicide at baseline, as determined by the study psychiatrist
See the full eligibility criteria
- Age ≥ 18, able to provide informed consent
- Patient diagnosed with treatment-resistant depression
- Outpatient recommended and approved by psychiatrist for ketamine treatment
- Patients who are on IV ketamine and requiring at least 4 treatments of IV ketamine per course (prescribed by their physiatrist)
- Cognitively alert, oriented, and able to watch immersive content and respond to questions
- Negative human chorionic gonadotropin test before treatment, for female participants of childbearing potential who are not practicing medically appropriate methods of birth control (e.g., hormonal contraceptives...
- History of psychosis/comorbid psychiatric disorders/psychotic depression/dissociative syndromes, significant personality disorder, as clinically assessed by psychiatrist
- Using non-prescribed substance (e.g., cannabis) or alcohol use within the preceding 48 hours of treatment
- History of substance misuse and/or dependence, including chronic alcohol abuse
- Previous ketamine use
- Acute dementia/delirium
- Acute risk of suicide at baseline, as determined by the study psychiatrist
- Pregnancy/breastfeeding
- Previous sensitivity to ketamine or related compounds
- Unstable medical condition which may require anesthesia consult
- History of elevated intracranial pressure or cerebrovascular accident
- Recent (within 6 weeks) major cardiovascular event (such as myocardial infarction)
- Significant motion sickness (i.e. occur during exposure to physical/visual and virtual motion, cybersickness, etc.) self-identified by patient
- Inability to communicate with the study team
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.