Integrating Ketamine Effects on Neuronal Molecular Signatures and the Brain Functional and Struct… (NCT06698848) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Integrating Ketamine Effects on Neuronal Molecular Signatures and the Brain Functional and Structural Connectome
United States120 participantsStarted 2025-01-01
Plain-language summary
Subanesthetic dose of intravenous ketamine (KET) has been found to be highly effective in rapid treatment depression and associated suicidality but its exact mechanism of remains uncertain. This study will use a novel approach to elucidate KET's effects on the molecular/ gene expression pathways in living neurons obtained from the olfactory epithelium and correlate the changes to rapid improvement in depression via changes in the brain connectome. The study will identify the molecular targets and pathways involved in KET'S mechanism of rapid clinical action and pave the way for development of novel, more efficacious, and safer therapeutic agents.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Able to give voluntary informed consent; 2. Satisfy criteria for Diagnostic and Statistical Manual 5th edition (DSM-V) for Major Depression Disorder (MDD) 3. Currently in a depressive episode (MDE); 4. Montgomery and Asberg Depression Rating Scale (MADRS) score \>21 but \<32(moderate to severe depression)11; 3. Psychotropic medication-free \> 2weeks and if on fluoxetine then for \>5 weeks at time of inclusion in the study(no taper or medication washout will be done for the purpose of the study). 6. Satisfy criteria to undergo an MRI scan based on MRI screening questionnaire; 7) able to be managed as outpatients during the study as ascertained by Clinical Global Severity Scale \< 5 (i.e., moderately ill) and no suicidal/homicidal intent or behavior or gross disability; and 8) no contraindication to KET treatment such as KET allergy or uncontrolled hypertension.
Exclusion Criteria:
* 1\. Meeting DSM-5 criteria for (hypo)mania, bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder, intellectual disability, or pervasive developmental disorder; 2. History of receiving electroconvulsive therapy in the past 1 year (due to possible effects on brain morphology); 3. Meeting DSM-5 criteria for moderate or severe substance/alcohol use within the past 6 months excluding caffeine or nicotine. The criteria will be evaluated by interview and urinary toxicology screening. The typical weekly use of caffeine, nicotine and alcohol will …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Montgomery Asberg Rating Scale (MADRS)
Timeframe: From enrollment to end of 1 week treatment