The purpose of this study is to compare the relative effectiveness, acceptability, and side effects of ketamine delivered through an IV (a drip into the arm) which is not currently FDA approved for use in the treatment of treatment-resistant depression (TRD) and Esketamine (Spravato®), taken as a nasal spray which has received FDA approval for use in the treatment of treatment-resistant depression (TRD) in the treatment of patients with treatment-resistant depression (TRD). The study will look at the following: * How well the treatment helps with symptoms of depression (effectiveness), * How comfortable and willing people are to use the treatment (acceptability), and * How well people can deal with any side effects from the treatment (tolerability). The study will also examine factors that may predict which treatment works better for certain patients.
This non-inferiority, multi-site, comparative effectiveness study will utilize a randomized design. Individuals with treatment resistant depression (TRD) will be randomized (1:1) to Spravato® or IV ketamine. This 5-year multisite comparative effectiveness study will enroll 400 total patients (\~200 per group).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Ketamine will be given intravenously. Per FDA guidance, the max dose of ketamine will be 60mg per day, with a total lifetime limit of 8 doses. Ketamine will be infused over 40 minutes.
Spravato® (Esketamine) will be given intranasally. For esketamine, the dose will be between 56 and 84mg, according to the FDA label for the drug. Allowances will be made for patients who have difficulty tolerating these doses to be dosed at 28mg in subsequent treatment sessions.
Mood Institute
Milford, Connecticut, United States
RECRUITINGYale School of Medicine
New Haven, Connecticut, United States
RECRUITINGEmory University
Atlanta, Georgia, United States
RECRUITINGUniversity of Michigan
Ann Arbor, Michigan, United States
ACTIVE_NOT_RECRUITINGLifeStance Health
Moore, Oklahoma, United States
ACTIVE_NOT_RECRUITINGAthena Care
Nashville, Tennessee, United States
RECRUITINGHouston Center for Advanced Psychiatric Treatment
Bellaire, Texas, United States
RECRUITINGSeattle NTC
Seattle, Washington, United States
RECRUITINGSelf-Reported Effectiveness
defined as the change in depression severity after 8 treatments, as assessed by the 16-item, patient-reported outcome, Quick Inventory of Depression Symptomatology (QIDS-SR16), at the end of one-month of treatment. Scale ranges from 0 - 27 with higher scores indicating worse depression.
Time frame: 30 days
Clinician-Reported Effectiveness
change in Montgomery-Asberg Depression Rating Scale (MADRS) score. Scale ranges from 0-60 with higher scores indicating worse depression.
Time frame: baseline until end of treatment (4 weeks)
Response
defined as a ≥50% decrease from baseline to end of week 4 on the Quick Inventory of Depression Symptomatology (QIDS-SR16). The proportion and number of participants with response will be compared between groups.
Time frame: baseline until end of treatment (4 weeks)
Remission
defined as a total score of ≤ 5 on the Quick Inventory of Depression Symptomatology (QIDS-SR16). The proportion and number of participants with remission will be compared between groups.
Time frame: baseline until end of treatment (4 weeks)
Suicidal Ideation and Behavior
The Columbia-Suicide Severity Scale Rating (C-SSRS) will be collected to examine any comparative differences in suicidal ideation. Scale ranges from 0-5 (for suicidal ideation) with higher scores indicating worse ideation. Scale for behavior measures counts of suicide behaviors.
Time frame: baseline until end of treatment (4 weeks)
Level of Disability
The Sheehan Disability Scale (SDS) will be used to assess any changes in patient disability levels associated with the treatments. The SDS is a patient rated discretized analog measure of functional disability in work, social and family life. Score for each subscale ranges from 0-10, with higher scores indicating worse disability.
Time frame: baseline until end of treatment (4 weeks)
Quality of Life
defined as changes in quality of life, as assessed by the Quality of Life in Depression Scale (QLDS). The QLDS will assess changes in the quality-of-life factors in relation to antidepressant treatments. The score ranges from 0-34, with higher scores indicating worse quality of life.
Time frame: baseline until end of treatment (4 weeks)
Utilization of Healthcare Resources
Measure using the Health Resource Utilization Questionnaire to track all cause healthcare utilization by assessing patients visits to all forms of healthcare providers and settings and tracking the use of other health related resources. In specific, group comparisons on specific types of patient visits (e.g., therapy visits, hospitalizations, ED visits) will be made. The scale measures counts of healthcare visits.
Time frame: end of treatment (4 weeks)
Acceptability
The 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) will be used as the key secondary outcome measure. The TSQM-9 is a validated tool for assessing patient satisfaction with treatment and covers the domains of effectiveness, convenience, and global satisfaction. Each domain is scored from 0-100 with lower scores indicating lower satisfaction. Behavioral measures will be used to assess treatment acceptability by comparing dropout rates and missed visits between the two treatment options.
Time frame: end of treatment (4 weeks after baseline)
Patient and Clinician Global Severity and Improvement
Global improvement of depression will be assessed with the Clinician and Patient Global Impression-Severity/Improvement indices. These are simple measures for clinicians and patients to provide information on overall depression severity and improvement with treatment. The scale ranges from 1-7 with higher scores indicating worse depression.
Time frame: baseline until end of treatment (4 weeks)
Tolerability and Safety
Tolerability will be based on group comparison of number of patients who experience adverse events of special interest. These include vomiting, dysphoric reactions, and clinically meaningful elevations in blood pressure and/or heart rate during the treatment session.
Time frame: baseline until end of treatment (4 weeks)
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