Depression
Conditions
Keywords
depression, ketamine, neurocognitive, fMRI, cognitive training
Brief summary
This study has two aims: 1) to characterize the effects of intravenous ketamine on neurocognitive markers in depressed patients; 2) to test the efficacy of a synergistic intervention for depression combining intravenous ketamine with neurocognitive training. Three of the primary outcomes listed (fMRI functional connectivity; Implicit Association Test; cognitive flexibility testing) pertain to Aim 1. For Aim 2, one primary clinical outcome (MADRS, a clinician-administered measure of depression severity) pertains to the acute (30-day) phase, while the QIDS (a self-report measure of depression severity) becomes the primary clinical outcome during the 12-month naturalistic follow-up.
Detailed description
This study measures clinical and mechanistic outcome trajectories following ketamine (with or without adjunctive neurocognitive training) measured over an acute (30-day) period; and subsequently (for a subset of measures) over a 12-month naturalistic follow-up period. NOTE: Corrections have been made to the Time Frame entries for all primary/secondary outcomes after identifying errors stemming from the study team's misunderstanding of the Time Frame query. Initially, the Time Frame query was misinterpreted to mean the range (minimum to maximum) length of the time interval over which any given assessment visit might query symptoms, and were therefore assigned erroneous values (1 day to 2 weeks; 1 day to lifetime) reflecting the time interval(s) queried by the instrument (e.g. at the +24 hours timepoint, symptoms are queried over a 1-day interval; at other assessment points, they could be queried over a 2-week interval for some measures, or over the entire lifetime for other measures). After recognizing this misinterpretation, the values have been adjusted to accurately reflect the a priori analytic plan.
Interventions
Intravenous ketamine is given at a subanesthetic dose, which previous research suggests is safe and efficacious for rapid relief from depression.
BEHAVIORALComputer-based Cognitive Training
Computer-based Cognitive Training will be delivered following intravenous ketamine to test whether learning during a post-ketamine window of opportunity might extend relief from depression.
Sponsors
National Institute of Mental Health (NIMH)
Rebecca Price
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Participants will: 1. be between the ages of 18 and 60 years, 2. have not responded to one or more adequate trials of FDA-approved antidepressants within the current depressive episode, determined by Antidepressant Treatment History Form 3. score ≥ 25 on the Montgomery Asberg Depression Rating Scale (MADRS) 4. score \>1SD above the normative mean on the Cognitive Triad Inventory self subscale \*OR\* \<1SD below the normative mean on the Rosenberg self-esteem scale 5. possess a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document 6. agree to sign a release of information (ROI), identifying another individual \[friend, family member, etc.\] as a contact person while the patient is enrolled in the study.
Exclusion criteria
1. Presence of lifetime bipolar, psychotic, or autism spectrum; current problematic substance use (e.g., substance use disorder); or lifetime recreational ketamine or PCP use 2. Use of a Monoamine Oxidase Inhibitor (MAOI) within the previous 2 weeks 3. Failure to meet standard MRI inclusion criteria: those who have cardiac pacemakers, neural pacemakers, cochlear implants, metal braces, or other non-MRI-compatible metal objects in their body, especially in the eye. Dental fillings do not present a problem. Plastic or removable dental appliances do not require exclusion. History of significant injury or surgery to the brain or spinal cord that would impair interpretation of results. 4. Current pregnancy or breastfeeding, or failure to engage in an effective birth control strategy throughout the duration of the study 5. Acute suicidality or other psychiatric crises requiring treatment escalation. 6. Changes made to treatment regimen within 4 weeks of baseline assessment 7. Reading level \<6th grade 8. For study entry, patients must be reasonable medical candidates for ketamine infusion, as determined by a board-certified physician co-investigator during study screening. Serious, unstable medical illnesses including respiratory \[obstructive sleep apnea, or history of difficulty with airway management during previous anesthetics\], cardiovascular \[including ischemic heart disease and uncontrolled hypertension\], and neurologic \[including history of severe head injury\] will be exclusions. 9. Clinically significant abnormal findings of laboratory parameters \[including urine toxicology screen for drugs of abuse\], physical examination, or ECG. 10. Uncontrolled or poorly controlled hypertension, as determined by a board-certified physician co-investigator's review of vitals collected during screening and any other relevant medical history/records. 11. Patients with one or more seizures without a clear and resolved etiology. 12. Patients starting hormonal treatment (e.g., estrogen) in the 3 months prior to Screening. Birth control is not an exclusion. 13. Past intolerance or hypersensitivity to ketamine or midazolam. 14. Patients taking medications with known activity at the NMDA or AMPA glutamate receptor \[e.g., riluzole, amantadine, lamotrigine, memantine, topiramate, dextromethorphan, D-cycloserine\], or the muopioid receptor. 15. Patients taking any of the following medications: St John's Wort, theophylline, tramadol, metrizamide 16. Patients who have received ECT in the past 6 months prior to Screening. 17. Patients currently receiving treatment with vagus nerve stimulation (VNS) or repetitive transcranial stimulation (rTMS). 18. Patients taking benzodiazepines (within 8 hours of infusion) or GABA agonists
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery Asberg Depression Scale | Trajectories from 24 hours through Day 30 post-infusion, Day 30 reported | Clinician-rated depression (range: 0-60; higher scores = worse outcome) |
| Executive-salience Network Functional Connectivity | Trajectories from 24 hours through Day 30 post-infusion, 24 hours reported | fMRI measure (beta weights where larger beta weight = stronger connectivity) |
| Implicit Self-representations | Trajectories from 24 hours through Day 30 post-infusion, Day 5 reported | Implicit Association Test composite difference score (performance-based measure; range = -inf-inf; high score=worse outcome; negatively signed value indicates associating oneself more strongly with positive than negative attributes) |
| Cognitive Flexibility | Trajectories from 24 hours through Day 30 post-infusion, Day 30 reported | Neurocognitive testing via NIH Toolbox DCCS fully-corrected T-scores (range = 0-100; high score=better outcome) |
| Quick Inventory of Depressive Symptoms | Trajectories from Day 30 through 12 months post-infusion (naturalistic follow-up), Month 12 reported | Self-reported depression (range: 0-27; higher scores = worse outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Measures-positive Affect | Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported | Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported positive affect/well-being T-score range: 0-100 (higher score = better outcome) |
| PROMIS Measures-sleep Disturbance | Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported | Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported sleep disturbance T-score range: 0-100 (higher score = worse outcome) |
| PROMIS Measures-cognitive Function | Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported | Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported cognitive function T-score range: 0-100 (higher score = better outcome) |
| PROMIS Measures-substance Use | Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported | Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported substance use Raw score range: 0-35 (higher score = worse outcome) |
| PROMIS Measures-alcohol | Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported | Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported alcohol use T-score range: 0-100 (higher score = worse outcome) |
| Executive-salience Network Functional Connectivity During Resting State | Trajectories from 24 hours through Day 30 post-infusion, 24 hours reported | fMRI measure (beta weights where larger beta weight = stronger connectivity) |
| Columbia-Suicide Severity Rating Scale | Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported | Suicidality and patient safety (most severe ideation score, range=0-5; higher score = worse outcome) |
| WHO Disability Assessment Scale (SR) | Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported | Global functioning (range=0-48; higher score = worse outcome) |
| Cognitive Flexibility Scale | Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported | Self-reported cognitive flexibility (range=12-72; higher score = better outcome) |
| Neuroplasticity-related Markers in Blood | 40min post-infusion | ketamine metabolite (2R,6R)-HNK concentration levels (range=0-inf; higher score = greater concentration in blood) |
| Cognitive Triad Inventory | Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported | Negative perceptions of self, future, & world (range=36-252; higher score = better outcome) |
| Affective Flexibility | Trajectories from 24 hours through Day 30 post-infusion, Day 30 reported | 'D-Prime' discrimination Z-score measured via accuracy of responses during the Affective Go/No-Go task (range: -inf-inf; high score=better performance; Z-score of 0=the sample mean) |
| PROMIS Measures-depression | Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported | Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported depression T-score range: 0-100 (higher score = worse outcome) |
| PROMIS Measures-anxiety | Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported | Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported anxiety T-score range: 0-100 (higher score = worse outcome) |
| PROMIS Measures-anger | Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported | Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported anger T-score range: 0-100 (higher score = worse outcome) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ketamine + Cognitive Training Intravenous ketamine: Intravenous ketamine is given at a subanesthetic dose, which previous research suggests is safe and efficacious for rapid relief from depression.
Computer-based Cognitive Training: Computer-based Cognitive Training will be delivered following intravenous ketamine to test whether learning during a post-ketamine window of opportunity might extend relief from depression. | 53 |
| Ketamine + Sham Training Intravenous ketamine: Intravenous ketamine is given at a subanesthetic dose, which previous research suggests is safe and efficacious for rapid relief from depression. | 50 |
| Saline + Cognitive Training Computer-based Cognitive Training: Computer-based Cognitive Training will be delivered following intravenous ketamine to test whether learning during a post-ketamine window of opportunity might extend relief from depression. | 51 |
| Total | 154 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Study withdrew participant due to repeated non-compliance | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 2 |
Baseline characteristics
| Characteristic | Ketamine + Cognitive Training | Total | Saline + Cognitive Training | Ketamine + Sham Training |
|---|---|---|---|---|
| Age, Continuous | 34.70 years STANDARD_DEVIATION 10.1 | 34.26 years STANDARD_DEVIATION 10.5 | 33.50 years STANDARD_DEVIATION 9.9 | 34.60 years STANDARD_DEVIATION 11.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 11 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants | 137 Participants | 47 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 6 Participants | 0 Participants | 3 Participants |
| Montgomery Asberg Depression Rating Scale | 32.28 units on a scale STANDARD_DEVIATION 5.7 | 32.78 units on a scale STANDARD_DEVIATION 5.3 | 32.61 units on a scale STANDARD_DEVIATION 5.1 | 33.48 units on a scale STANDARD_DEVIATION 4.9 |
| Number of failed antidepressant trials | 2.66 trials STANDARD_DEVIATION 1.59 | 2.64 trials STANDARD_DEVIATION 1.93 | 2.67 trials STANDARD_DEVIATION 2.46 | 2.60 trials STANDARD_DEVIATION 1.67 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 9 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 7 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 11 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 44 Participants | 125 Participants | 41 Participants | 40 Participants |
| Sex: Female, Male Female | 32 Participants | 97 Participants | 33 Participants | 32 Participants |
| Sex: Female, Male Male | 21 Participants | 57 Participants | 18 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 103 | 0 / 51 |
| other Total, other adverse events | 102 / 103 | 38 / 51 |
| serious Total, serious adverse events | 0 / 103 | 0 / 51 |
Outcome results
Primary
Cognitive Flexibility
Neurocognitive testing via NIH Toolbox DCCS fully-corrected T-scores (range = 0-100; high score=better outcome)
Time frame: Trajectories from 24 hours through Day 30 post-infusion, Day 30 reported
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Cognitive Flexibility | 54.51 score on a scale | Standard Deviation 13.33 |
| Ketamine + Sham Training | Cognitive Flexibility | 49.34 score on a scale | Standard Deviation 12.48 |
| Saline + Cognitive Training | Cognitive Flexibility | 53.25 score on a scale | Standard Deviation 12.98 |
Primary
Executive-salience Network Functional Connectivity
fMRI measure (beta weights where larger beta weight = stronger connectivity)
Time frame: Trajectories from 24 hours through Day 30 post-infusion, 24 hours reported
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Executive-salience Network Functional Connectivity | 0.55 beta weights | Standard Deviation 0.11 |
| Ketamine + Sham Training | Executive-salience Network Functional Connectivity | 0.59 beta weights | Standard Deviation 0.11 |
| Saline + Cognitive Training | Executive-salience Network Functional Connectivity | 0.57 beta weights | Standard Deviation 0.1 |
Primary
Implicit Self-representations
Implicit Association Test composite difference score (performance-based measure; range = -inf-inf; high score=worse outcome; negatively signed value indicates associating oneself more strongly with positive than negative attributes)
Time frame: Trajectories from 24 hours through Day 30 post-infusion, Day 5 reported
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Implicit Self-representations | -.16 factor score | Standard Deviation 1 |
| Ketamine + Sham Training | Implicit Self-representations | 0.15 factor score | Standard Deviation 1.03 |
| Saline + Cognitive Training | Implicit Self-representations | 0.03 factor score | Standard Deviation 0.97 |
Primary
Montgomery Asberg Depression Scale
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
Time frame: Trajectories from 24 hours through Day 30 post-infusion, Day 30 reported
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Montgomery Asberg Depression Scale | 19.72 score on a scale | Standard Deviation 10.2 |
| Ketamine + Sham Training | Montgomery Asberg Depression Scale | 22.87 score on a scale | Standard Deviation 11.63 |
| Saline + Cognitive Training | Montgomery Asberg Depression Scale | 23.51 score on a scale | Standard Deviation 9.66 |
p-value: 0.0004Regression, Linear
Primary
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Time frame: Trajectories from Day 30 through 12 months post-infusion (naturalistic follow-up), Month 12 reported
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Quick Inventory of Depressive Symptoms | 10.77 score on a scale | Standard Deviation 6.84 |
| Ketamine + Sham Training | Quick Inventory of Depressive Symptoms | 12.03 score on a scale | Standard Deviation 5.94 |
| Saline + Cognitive Training | Quick Inventory of Depressive Symptoms | 10.42 score on a scale | Standard Deviation 4.38 |
Secondary
Affective Flexibility
'D-Prime' discrimination Z-score measured via accuracy of responses during the Affective Go/No-Go task (range: -inf-inf; high score=better performance; Z-score of 0=the sample mean)
Time frame: Trajectories from 24 hours through Day 30 post-infusion, Day 30 reported
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Affective Flexibility | -.18 Z-score | Standard Deviation 1.71 |
| Ketamine + Sham Training | Affective Flexibility | -.07 Z-score | Standard Deviation 1.52 |
| Saline + Cognitive Training | Affective Flexibility | 0.26 Z-score | Standard Deviation 1.62 |
Secondary
Cognitive Flexibility Scale
Self-reported cognitive flexibility (range=12-72; higher score = better outcome)
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Cognitive Flexibility Scale | 52.64 score on a scale | Standard Deviation 8.82 |
| Ketamine + Sham Training | Cognitive Flexibility Scale | 50.82 score on a scale | Standard Deviation 10.81 |
| Saline + Cognitive Training | Cognitive Flexibility Scale | 51.20 score on a scale | Standard Deviation 10.46 |
Secondary
Cognitive Triad Inventory
Negative perceptions of self, future, & world (range=36-252; higher score = better outcome)
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Cognitive Triad Inventory | 133.89 score on a scale | Standard Deviation 35.15 |
| Ketamine + Sham Training | Cognitive Triad Inventory | 126.00 score on a scale | Standard Deviation 39.02 |
| Saline + Cognitive Training | Cognitive Triad Inventory | 138.97 score on a scale | Standard Deviation 28.5 |
Secondary
Columbia-Suicide Severity Rating Scale
Suicidality and patient safety (most severe ideation score, range=0-5; higher score = worse outcome)
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Columbia-Suicide Severity Rating Scale | 0.70 score on a scale | Standard Deviation 1.14 |
| Ketamine + Sham Training | Columbia-Suicide Severity Rating Scale | 1.30 score on a scale | Standard Deviation 1.24 |
| Saline + Cognitive Training | Columbia-Suicide Severity Rating Scale | 1.10 score on a scale | Standard Deviation 1.29 |
Secondary
Executive-salience Network Functional Connectivity During Resting State
fMRI measure (beta weights where larger beta weight = stronger connectivity)
Time frame: Trajectories from 24 hours through Day 30 post-infusion, 24 hours reported
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Executive-salience Network Functional Connectivity During Resting State | 0.53 beta weights | Standard Deviation 0.1 |
| Ketamine + Sham Training | Executive-salience Network Functional Connectivity During Resting State | 0.50 beta weights | Standard Deviation 0.09 |
| Saline + Cognitive Training | Executive-salience Network Functional Connectivity During Resting State | 0.51 beta weights | Standard Deviation 0.12 |
Secondary
Neuroplasticity-related Markers in Blood
ketamine metabolite (2R,6R)-HNK concentration levels (range=0-inf; higher score = greater concentration in blood)
Time frame: 40min post-infusion
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Neuroplasticity-related Markers in Blood | 26.94 ng/mL | Standard Deviation 11.59 |
| Ketamine + Sham Training | Neuroplasticity-related Markers in Blood | 27.35 ng/mL | Standard Deviation 11.76 |
Secondary
PROMIS Measures-alcohol
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported alcohol use T-score range: 0-100 (higher score = worse outcome)
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | PROMIS Measures-alcohol | 46.29 score on a scale | Standard Deviation 8.56 |
| Ketamine + Sham Training | PROMIS Measures-alcohol | 47.82 score on a scale | Standard Deviation 5.35 |
| Saline + Cognitive Training | PROMIS Measures-alcohol | 47.25 score on a scale | Standard Deviation 7.04 |
Secondary
PROMIS Measures-anger
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported anger T-score range: 0-100 (higher score = worse outcome)
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | PROMIS Measures-anger | 50.27 score on a scale | Standard Deviation 13.03 |
| Ketamine + Sham Training | PROMIS Measures-anger | 54.21 score on a scale | Standard Deviation 10.44 |
| Saline + Cognitive Training | PROMIS Measures-anger | 49.59 score on a scale | Standard Deviation 10.23 |
Secondary
PROMIS Measures-anxiety
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported anxiety T-score range: 0-100 (higher score = worse outcome)
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | PROMIS Measures-anxiety | 58.07 score on a scale | Standard Deviation 9.42 |
| Ketamine + Sham Training | PROMIS Measures-anxiety | 62.49 score on a scale | Standard Deviation 9.26 |
| Saline + Cognitive Training | PROMIS Measures-anxiety | 57.88 score on a scale | Standard Deviation 8.87 |
Secondary
PROMIS Measures-cognitive Function
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported cognitive function T-score range: 0-100 (higher score = better outcome)
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | PROMIS Measures-cognitive Function | 43.61 score on a scale | Standard Deviation 9.54 |
| Ketamine + Sham Training | PROMIS Measures-cognitive Function | 39.19 score on a scale | Standard Deviation 8.07 |
| Saline + Cognitive Training | PROMIS Measures-cognitive Function | 44.87 score on a scale | Standard Deviation 8.81 |
Secondary
PROMIS Measures-depression
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported depression T-score range: 0-100 (higher score = worse outcome)
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | PROMIS Measures-depression | 58.97 score on a scale | Standard Deviation 12.15 |
| Ketamine + Sham Training | PROMIS Measures-depression | 61.01 score on a scale | Standard Deviation 9.54 |
| Saline + Cognitive Training | PROMIS Measures-depression | 57.13 score on a scale | Standard Deviation 9.57 |
Secondary
PROMIS Measures-positive Affect
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported positive affect/well-being T-score range: 0-100 (higher score = better outcome)
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | PROMIS Measures-positive Affect | 44.12 score on a scale | Standard Deviation 7.72 |
| Ketamine + Sham Training | PROMIS Measures-positive Affect | 44.02 score on a scale | Standard Deviation 7.76 |
| Saline + Cognitive Training | PROMIS Measures-positive Affect | 45.98 score on a scale | Standard Deviation 7.6 |
Secondary
PROMIS Measures-sleep Disturbance
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported sleep disturbance T-score range: 0-100 (higher score = worse outcome)
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | PROMIS Measures-sleep Disturbance | 53.06 score on a scale | Standard Deviation 9.91 |
| Ketamine + Sham Training | PROMIS Measures-sleep Disturbance | 53.78 score on a scale | Standard Deviation 8.63 |
| Saline + Cognitive Training | PROMIS Measures-sleep Disturbance | 51.41 score on a scale | Standard Deviation 10.29 |
Secondary
PROMIS Measures-substance Use
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported substance use Raw score range: 0-35 (higher score = worse outcome)
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | PROMIS Measures-substance Use | 3.00 score on a scale | Standard Deviation 5.22 |
| Ketamine + Sham Training | PROMIS Measures-substance Use | 2.32 score on a scale | Standard Deviation 5.09 |
| Saline + Cognitive Training | PROMIS Measures-substance Use | 3.03 score on a scale | Standard Deviation 5.94 |
Secondary
WHO Disability Assessment Scale (SR)
Global functioning (range=0-48; higher score = worse outcome)
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | WHO Disability Assessment Scale (SR) | 10.58 score on a scale | Standard Deviation 9.28 |
| Ketamine + Sham Training | WHO Disability Assessment Scale (SR) | 15.75 score on a scale | Standard Deviation 10.87 |
| Saline + Cognitive Training | WHO Disability Assessment Scale (SR) | 12.64 score on a scale | Standard Deviation 10.72 |