There are many common pharmacological treatments for major depression disorder (MDD), however the efficacy of these drugs often fails in severe cases. Intravenous (IV) administered ketamine may offer the potential for remission of the symptoms in patients with MDD; however it has not yet been approved by FDA for this purpose. This study will make use of an electroencephalography (EEG) machine to measure the brain's activity and response while the IV ketamine is being delivered. The objective of this study is to characterize the change in EEG response of patients with MDD, during and 4 weeks after a course of IV ketamine infusions.
This study will enroll 35 patients with major depressive disorder. Candidates for participation in the study will typically be either referred to the clinic through their healthcare provider or will have sought out participation on their own accord based on advertising. Subjects will be screened for eligibility and suitable patients will be invited to attend a screening visit in the clinic and complete informed consent. Upon determining eligibility, subjects will have their first treatment session booked within 42 days of screening (Baseline, visit 0). Three subsequent weekly (±3 days) ketamine therapy treatment sessions will occur on days 7, 14 and 21, for a total of four ketamine infusions over four weeks. All patients will return for a follow-up visit at 4-weeks post final treatment visit, day 49.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Patients with a diagnosis of Major Depressive Disorder (MDD) will be enrolled to receive four 50-60 minute infusions of 60mg ketamine hydrochloride
Characterizing the changes in EEG reading frequencies from pre- IV ketamine infusion treatment (baseline).
Alpha, Beta, Delta, Theta and Gamma frequencies will be examined with portable NeuroEEG™, a 19 channels and 22 electrodes cap based on 10-20 distribution
Time frame: 30-minute pre-treatment baseline and throughout infusion (approximately 50-60 minutes)
Characterizing the changes in EEG reading waveforms from pre- IV ketamine infusion treatment (baseline).
Alpha, Beta, Delta, Theta and Gamma waveforms will be examined with portable NeuroEEG™, a 19 channels and 22 electrodes cap based on 10-20 distribution
Time frame: 30-minute pre-treatment baseline and throughout infusion (approximately 50-60 minutes)
Characterizing the changes in EEG reading amplitudes from pre- IV ketamine infusion treatment (baseline).
Alpha, Beta, Delta, Theta and Gamma amplitude will be examined with portable NeuroEEG™, a 19 channels and 22 electrodes cap based on 10-20 distribution
Time frame: 30-minute pre-treatment baseline and throughout infusion (approximately 50-60 minutes)
Characterizing the changes in EEG reading patterns from pre- IV ketamine infusion treatment (baseline).
Alpha, Beta, Delta, Theta and Gamma reading patterns will be examined with portable NeuroEEG™, a 19 channels and 22 electrodes cap based on 10-20 distribution
Time frame: 30-minute pre-treatment baseline and throughout infusion (approximately 50-60 minutes)
Characterizing the changes in EEG reading frequencies from pre- IV ketamine infusion treatment (baseline) and 4 weeks post-treatment course
Alpha, Beta, Delta, Theta and Gamma frequencies will be examined with portable NeuroEEG™, a 19 channels and 22 electrodes cap based on 10-20 distribution
Time frame: Pre-treatment baseline, 4 weeks post-treatment course
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Characterizing the changes in EEG reading waveforms from pre- IV ketamine infusion treatment (baseline) and 4 weeks post-treatment course
Alpha, Beta, Delta, Theta and Gamma waveforms will be examined with portable NeuroEEG™, a 19 channels and 22 electrodes cap based on 10-20 distribution
Time frame: Pre-treatment baseline, 4 weeks post-treatment course
Characterizing the changes in EEG reading amplitudes from pre- IV ketamine infusion treatment (baseline) and 4 weeks post-treatment course
Alpha, Beta, Delta, Theta and Gamma amplitude will be examined with portable NeuroEEG™, a 19 channels and 22 electrodes cap based on 10-20 distribution
Time frame: Pre-treatment baseline, 4 weeks post-treatment course
Characterizing the changes in EEG reading patterns from pre- IV ketamine infusion treatment (baseline) and 4 weeks post-treatment course
Alpha, Beta, Delta, Theta and Gamma amplitude will be examined with portable NeuroEEG™, a 19 channels and 22 electrodes cap based on 10-20 distribution
Time frame: Pre-treatment baseline, 4 weeks post-treatment course
Incidence of medically significant changes in blood pressure during ketamine infusion
Time frame: Pre-treatment baseline; treatment initiation, 0 minutes; 20 minutes, 40 minutes; 60 minutes post-infusion
Incidence of medically significant changes in Oxygen Saturation (SpO2) during ketamine infusion
Time frame: Pre-treatment baseline; treatment initiation, 0 minutes; 20 minutes, 40 minutes; 60 minutes post-infusion
Incidence of medically significant changes in heart rate during ketamine infusion
Time frame: Pre-treatment baseline; treatment initiation, 0 minutes; 20 minutes, 40 minutes; 60 minutes post-infusion
Incidence of medically significant changes in respiratory rate during ketamine infusion
Time frame: Pre-treatment baseline; treatment initiation, 0 minutes; 20 minutes, 40 minutes; 60 minutes post-infusion
Changes from baseline in the Dissociative Experiences Scale (DES) Total Score
The Dissociative Experiences Scale (DES) is a 28-item scale assessing the subject's experiences in his/her daily life. The subject determines to what degree he/she has been facing the situation by selecting a percentage from 0% (never) to 100% (always), with 10% increments in between. Higher scores mean higher severity
Time frame: Baseline (Day 0), follow-up visit (Day 42)