Gamma Oscillations as a Prognostic Marker for Ketamine Therapy in Treatment Resistant Depression
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-45
SponsorTexas A&M University
About this trial
The core objective of this study is to enhance the translational potential of this electroencephalogram (EEG) biomarker by using ketamine(KET)-induced gamma potentiation as a prognostic marker of 4-week treatment outcome. Previous research focused exclusively on KET-induced gamma band potentiation (GBP) in the context of a single infusion. Our study design captures the clinical variation associated with real-world treatment resistant depression (TRD) patients and allows us to analyze the relative importance of GBP to antidepressant symptom reduction across the induction phase of treatment. If successful, it provides a compelling rationale for a larger prospective investigation of gamma dynamics as a moderator of outcome to varied TRD therapies which impact the balance of cortical excitation and inhibition.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
General
The criteria for eligibility described here are intended to protect patient welfare where, for example, the administration of ketamine in the context of standardized research (i.e. pharmaco-EEG challenge) would be inadvisable or unsafe. An additional purpose is to decrease psychiatric co-morbidities that may affect the clinical phenomenology or treatment response and thus obscure findings. Further, by virtue of the eligibility criteria the investigators seek to limit variability due to demographic and other factors.
Male or Female ages 21-45, inclusive.
Level of understanding sufficient to agree to all tests and examinations required by the protocol.
Disqualifiers
History of MDD with psychotic features, bipolar disorder, schizophrenia spectrum and other psychotic disorders, currently exhibiting psychotic features, or a first-degree relative with a psychotic disorder.
Diagnosed with intellectual disability.
Current major medical problems that affect brain anatomy, neurochemistry, or function, e.g., liver insufficiency, kidney insufficiency, cardiovascular problems, (unstable Arrhythmias, Chronic Heart Failure, Myocardial Infarction (MI) cardiac pacemaker), systemic infections, cancer, active upper respiratory infections, respiratory depression and any brain disorder (seizure disorder, stroke, dementia, degenerative neurologic diseases), and head injury with loss of consciousness for any period of time.
Pregnancy or Breast-feeding. All female participants in reproductive age will undergo pregnancy tests. Female participants will be required to provide evidence of use of contraceptives during the course of the study.
Trial design
Design model
Crossover
Treatments tested in this trial
Ketamine
DrugKetamine infusion amount is dictated by BMI, sex, and age.
Saline
Other interventionSaline infusion amount is dictated by BMI, sex, and age.
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: Healthy ControlsActive comparator 2 interventions
Group B: Major Depressive DisorderActive comparator 2 interventions
Group C: Treatment Resistant DepressionActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Resting State Gamma Power
Gamma power is the resting state electroencephalogram represents the amplitude of oscillations measuring the in the 30+ hertz (Hz) range of the power-spectrum. This is used as a proxy measure of the level of cortical disinhibition occurring at rest.
Time frame
Before infusion, during infusion, 60-90 minutes after infusion2
Auditory Steady State Response Gamma Power
Auditory Steady State Response gamma power represents the entrainment of inhibitory interneurons in response to a train of short tones, resembling a high frequency click, that are presented for a 1000ms at a rate of 40 Hz.
Time frame
Before infusion, during infusion, 60-90 minutes after infusion3
Montgomery-Asberg Depression Rating Scale (MADRS)
The MADRS is a clinician administered rating scale consisting of 10 items to measure depression symptom severity. Each item has a rating scale of 0-6. Greater total scores indicate more severe depression.
Time frame
Study entry, pre-infusion, study exit visit (up to a month after infusion)Secondary outcomes
1
Quick Inventory of Depressive Severity Self Report (QIDS-SR)
The Quick Inventory of Depressive Severity Self Report is a 16 item measure of core behavioral domains associated with depression. These cover: sleep/wake cycles, affect, appetite, weight, concentration and decision making, self-perception, suicidality, general interest, and energy levels. Each item has a rating scale 0-3. Greater total scores indicate more severe depression
Time frame
Study entry, pre-infusion, study exit visit (up to a month after infusion)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Texas A&M University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov