Ketamine Associated ACC GABA and Glutamate Change and Depression Remission:

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-03

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intravenous Ketamine for Treatment-Resistant Depression

NCT06668571

Depressive Disorder, Treatment-Resistant Treatment Resistant Depression (TRD)

RECRUITING PHASE2

Clinical Trial of the Use of Ketamine in Treatment Resistant Depression

NCT02610712

Depressive Disorder, Treatment-Resistant

UNKNOWN PHASE4

Pilot Study: Establishing Glutamatergic Changes in Rapid Antidepressant Effects of Ketamine

NCT06788249

Major Depressive Disorder (MDD)

NOT_YET_RECRUITING EARLY_PHASE1

Ketamine Infusion for Treatment-resistant Major Depressive Disorder

NCT01582945

Major Depressive Disorder

COMPLETED NA

A Study to Investigate Evoked Potentials as Markers of Ketamine-induced Cortical Plasticity in Patients With Major Depressive Disorder

NCT01957410

Major Depressive Disorder

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Aims: This feasibility study aims to better understand the neurobiology of major depression and how ketamine may therapeutically impact brain function. This research may provide important insights into the mechanism of ketamine response, thus, potentially increasing the likelihood of successful treatment interventions and decrease the number of ineffective treatments and/or risk for serious side effects.

SPECIFIC AIMS:

Utilizing novel dynamic sliding-window functional MR spectroscopy (fMRS) and liquid chromatography-mass spectrometry (LCMS), we aim to evaluate the relationship between GABA and glutamate (central-baseline to peak and peripheral-baseline to 24 hours) levels with a change in depression symptoms (baseline to 24 hours), after a single infusion of intravenous (IV) ketamine, in subjects with treatment-resistant depression (TRD).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depressive Disorder Treatment Resistant Depression Bipolar Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ketamine

Open-label, non-randomized

Group Type OTHER

Ketamine

Intervention Type DRUG

We will enroll 20 adults (aged 18-65 years) with treatment-resistant depression and will provide two i.v. ketamine infusions (0.5 mg/kg, infused over 40 minutes) and measure their depressive symptom responses. Biomarkers will be developed using blood samples from study subjects, taken prior to (predictive biomarkers), and following ketamine treatment (change biomarkers). This will be an open-label feasibility trial.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ketamine

We will enroll 20 adults (aged 18-65 years) with treatment-resistant depression and will provide two i.v. ketamine infusions (0.5 mg/kg, infused over 40 minutes) and measure their depressive symptom responses. Biomarkers will be developed using blood samples from study subjects, taken prior to (predictive biomarkers), and following ketamine treatment (change biomarkers). This will be an open-label feasibility trial.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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 symptoms;
* Ongoing prescription of \> 4 mg lorazepam equivalents (total) daily, or morning dosing of any benzodiazepine at the time of assessment;
* Medications known to affect glutamate (i.e., riluzole, carbamazepine) or GABA (zaleplon, zolpidem, zopiclone, valproate, gabapentin, pregabalin, tiagabine, and vigabatrin) are prohibited within two weeks prior to administration of study drug;
* Antidepressant Monoamine Oxidase Inhibitors (MAOIs) are prohibited two weeks prior to the administration of the study drug.
* CYP3A4 inducers carbamazepine and modafinil are prohibited within two weeks prior to administration of the study drug and at least 24 hours after the last dose of study drug.
* Currently undergoing TMS, vagal nerve stimulation, or deep brain stimulation as either an acute or maintenance treatment of depression;
* ECT in the past 12 months;
* Any active or unstable medical condition judged by the study psychiatrist as conferring too great a level of medical risk to allow inclusion in the study;
* Use of methamphetamine, cocaine, or cannabis. Abuse of stimulant(s) within the prior 12 months;
* Any current substance use disorder (excluding nicotine and caffeine). Note: Persons will be allowed to enroll in this study if their substance use is in complete (not partial) and sustained (\> 1 year) remission;
* History of traumatic brain injury that resulted in loss of consciousness;
* Developmental delay, intellectual disability, or intellectual disorder;
* Clinical or self-reported diagnosis of delirium, encephalopathy, or related clinical diagnosis within the prior 12 months;
* Cognitive disorder (mild and major categories, per DSM-);
* Received ketamine treatment for depression within the prior 2 months;
* History of either poor antidepressive response to or poor tolerability of ketamine (any route of administration) when previously administered for treating symptoms of depression;
* History of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic for 6 months;
* Hepatic insufficiency (2.5 X ULN for AST or ALT) within 1 year of consent, past liver transplant recipient, and/or clinical diagnosis of cirrhosis of the liver;
* Gastroesophageal reflux disease
* A diagnosis of Complex Regional Pain Syndrome (CRPS);
* Pregnancy, or nursing;
* History of claustrophobia
* Any contraindication to MRI safety questionnaire

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No