Ketamine Associated ACC GABA and Glutamate Change and Depression Remission: (NCT03573349) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Ketamine Associated ACC GABA and Glutamate Change and Depression Remission:
United States18 participantsStarted 2019-01-03
Plain-language summary
This is a feasibility study and the goal of this project is to evaluate whether peak ACC GABA and glutamate, quantified as a CSF-corrected absolute concentration percent change from baseline, is associated with clinical remission, Montgomery Asberg Depression Rating Scale (MADRS) total score of \<10, to the anti-glutamatergic antidepressant ketamine.
As MRS is expensive, we also aim to study a correlation between change in peripheral metabolites (GABA and glutamate) and central GABA and glutamate levels.
Who can participate
Age range
18 Years – 65 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:
For inclusion in this study, the following will be required:
* Ability to provide informed consent;
* Current psychiatric inpatient (voluntary only) or outpatient treatment;
* Male or female;
* Age 18-65 years;
* Meets diagnostic criteria for major depressive disorder/bipolar depression without psychotic features per the SCID DSM-IV-TR;
* PHQ-9 total score ≥ 15 at screening and at baseline (just prior to first acute phase ketamine infusion);
* Treatment-resistant depression (TRD), as defined by failure of at least two previous antidepressant treatments within the current depressive episode. Failed antidepressant treatments can include pharmacotherapy for depression at an adequate dose for at least 8 weeks, or an acute series of at least 6 administrations of electroconvulsive therapy (ECT) or an acute series of Transcranial magnetic stimulation (TMS);
* Ability to pass a comprehension assessment test related to effects of ketamine and trial objectives and criteria.
Exclusion Criteria: Based on ketamine's known difficulties with the induction of perceptual/psychomimetic symptoms, the exclusion criteria for this study will be as follows:
* Inability to speak English
* Patients with a BMI \>40.
* Any current psychiatric diagnosis other than anxiety disorders needing concurrent antidepressant therapy
* Personality disorder being the primary diagnosis
* Diagnosis of schizophrenia, schizoaffective disorder, post-traumatic stress disorder, or active psychotic …
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.
1This trial is in early Phase 1 and is actively enrolling no new participants — does that mean I've missed the window to join, and if so, are there similar ketamine brain-imaging studies my doctor knows of that are still open?
2Since this study is measuring chemical changes in a specific brain region called the anterior cingulate cortex during a 40-minute IV ketamine infusion, what does my doctor think that kind of monitoring would mean for me practically — would I need specialized MRI or brain-scanning equipment during the infusion itself?
3The trial is looking at whether people reach remission on a depression scale within just 24 hours of a ketamine infusion — given how quickly that's being measured, what does my doctor think about ketamine's longer-term effects for someone with my diagnosis, whether that's major depressive disorder, treatment-resistant depression, or bipolar depression?
4Because this is an early Phase 1 study focused mainly on understanding brain chemistry changes rather than proving a treatment works, should I be considering more established ketamine treatment options or other approved therapies before thinking about research-stage studies like this one?
5Given that the trial involves bipolar depression as one of its conditions, how would my doctor weigh the specific risks of ketamine for someone with bipolar disorder, since that population can sometimes have different responses to treatments that affect mood rapidly?
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
To evaluate percent change in the anterior cingulate cortex (ACC) GABA and Glutamate (baseline to peak) during a 40-minute IV ketamine infusion and remission (MADRS ≤9) at 24 hour
Timeframe: 24 hour
2
To evaluate a correlation between percent change in ACC GABA and Glutamate/Glx levels (baseline to peak) with a change in MADRS (baseline to 24 hours).