Depression, Unipolar
Conditions
Brief summary
In this project, the investigators will administer a single infusion of IV ketamine to depressed patients and randomize the patients to receive either a) usual/typical infusion conditions or b) mindfulness training and exercises in conjunction with the infusion. Investigators will test whether the conjunction of ketamine + mindfulness enhances the reductions in depression following a single ketamine infusion.
Detailed description
NOTE: The study's target sample size was revised after beginning the study, based on a revised available budget.
Interventions
Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
BEHAVIORALBrief Mindfulness Exercises
30min guided training in mindfulness meditation immediately prior to infusion
BEHAVIORALAcademic Exercises
30min of mental math and other academic cognitive puzzles completed silently/mentally
Sponsors
Rebecca Price
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
All participants will: 1. be between the ages of 18 and 65 years, 2. score ≥ 14 on the Hamilton Depression Rating Scale (modified Ham-D) 3. possess a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document
Exclusion criteria
All participants: 1. Presence of lifetime bipolar, psychotic, or autism spectrum; current problematic substance use (e.g., ongoing moderate-to-severe substance use disorder); 2. Acute suicidality or other psychiatric crises requiring treatment escalation. We will use the Columbia Suicide Severity Rating Scale (CSSRS) as both an initial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale | 24hrs post-intervention | Clinician-rated depression (range: 0-60; higher scores = worse outcome) |
| State Mindfulness Scale | 80min post-infusion | Self-reported mindfulness (range 21-105; higher scores = more mindfulness) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Hamilton Depression Rating Scale | 24hrs post-intervention | Clinician-rated depression (range: 0-52; higher scores = worse outcome) |
| Quick Inventory of Depressive Symptoms | 24hrs post-intervention | Self-reported depression (range: 0-27; higher scores = worse outcome) |
| Hood Mysticism Scale | 40 minutes post-intervention | clinician-administered to assess mystical experiences (range: -64 to +64; higher scores = greater mystical experience) |
| Mindful Attention Awareness Scale | 24hrs post-intervention | self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness) |
| Daily Spiritual Experience Scale | 5 days post-intervention | self-reported spiritual experiences (range: 1-6; higher scores=greater spiritual experience) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sustained Attention Response Task (SART) Self-reported Task Focus | infusion +24 hours (1 day) | self-report rating of being on-task (range: 1-7; higher score=more on-task) |
| Awe Experience Scale | infusion +80min | self-report measure of awe-inspiring experiences (range: 30-210; higher score=greater awe) |
| Sustained Attention Response Task (SART) Omission Errors | infusion +24 hours (1 day) | performance-based measure of mindful attention |
| Dual Probe Video Task | infusion +24 hours (1 day) | attentional bias (proportion score) towards sad film clips (range: 0-1.0; higher score=greater attention bias towards sad films) |
| Pain Rating Via Quantitative Sensory Testing | 1-hour post-infusion | Pain rating obtained from Quantitative Sensory Testing by mechanical temporal summation (range: 0-10; higher score=more pain) |
| PROMIS Pain Intensity Score | 1-hour post-infusion | PROMIS Pain Intensity Short Form scale T-score (range=0-100; higher score=worse pain) |
| PROMIS Pain Interference Score | 1-hour post-infusion | PROMIS Pain Interference Short Form scale T-score (range=0-100; higher score=worse pain) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intravenous Ketamine + Mindfulness Exercises Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
Brief Mindfulness Exercises: 30min guided training in mindfulness meditation immediately prior to infusion | 22 |
| Intravenous Ketamine + Academic Exercises Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
Academic Exercises: 30min of mental math and other academic cognitive puzzles completed silently/mentally | 21 |
| Total | 43 |
Baseline characteristics
| Characteristic | Intravenous Ketamine + Mindfulness Exercises | Total | Intravenous Ketamine + Academic Exercises |
|---|---|---|---|
| Age, Continuous | 40.00 years STANDARD_DEVIATION 13.82 | 38.07 years STANDARD_DEVIATION 13.51 | 36.05 years STANDARD_DEVIATION 30.29 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 4 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 38 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Montgomery Asberg Depression Rating Scale | 30.64 units on a scale STANDARD_DEVIATION 6.27 | 30.47 units on a scale STANDARD_DEVIATION 6.17 | 30.29 units on a scale STANDARD_DEVIATION 6.21 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 34 Participants | 17 Participants |
| Sex: Female, Male Female | 14 Participants | 28 Participants | 14 Participants |
| Sex: Female, Male Male | 8 Participants | 15 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 21 |
| other Total, other adverse events | 22 / 22 | 21 / 21 |
| serious Total, serious adverse events | 0 / 22 | 0 / 21 |
Outcome results
Primary
Montgomery-Asberg Depression Rating Scale
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
Time frame: 30 days post-intervention
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ketamine + Mindfulness Exercises | Montgomery-Asberg Depression Rating Scale | 18.55 score on a scale | Standard Deviation 12.02 |
| Intravenous Ketamine + Academic Exercises | Montgomery-Asberg Depression Rating Scale | 20.05 score on a scale | Standard Deviation 11.64 |
Primary
Montgomery-Asberg Depression Rating Scale
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
Time frame: 24hrs post-intervention
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ketamine + Mindfulness Exercises | Montgomery-Asberg Depression Rating Scale | 12.50 score on a scale | Standard Deviation 7.94 |
| Intravenous Ketamine + Academic Exercises | Montgomery-Asberg Depression Rating Scale | 13.30 score on a scale | Standard Deviation 8.9 |
Primary
Montgomery-Asberg Depression Rating Scale
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
Time frame: 5 days post-intervention
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ketamine + Mindfulness Exercises | Montgomery-Asberg Depression Rating Scale | 15.81 score on a scale | Standard Deviation 7.84 |
| Intravenous Ketamine + Academic Exercises | Montgomery-Asberg Depression Rating Scale | 14.30 score on a scale | Standard Deviation 10.69 |
Primary
Montgomery-Asberg Depression Rating Scale
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
Time frame: 12 days post-intervention
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ketamine + Mindfulness Exercises | Montgomery-Asberg Depression Rating Scale | 15.43 score on a scale | Standard Deviation 8.42 |
| Intravenous Ketamine + Academic Exercises | Montgomery-Asberg Depression Rating Scale | 17.21 score on a scale | Standard Deviation 11.74 |
Primary
Montgomery-Asberg Depression Rating Scale
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
Time frame: 21 days post-intervention
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ketamine + Mindfulness Exercises | Montgomery-Asberg Depression Rating Scale | 18.90 score on a scale | Standard Deviation 11.71 |
| Intravenous Ketamine + Academic Exercises | Montgomery-Asberg Depression Rating Scale | 17.10 score on a scale | Standard Deviation 11.39 |
Primary
State Mindfulness Scale
Self-reported mindfulness (range 21-105; higher scores = more mindfulness)
Time frame: 80min 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 |
|---|---|---|---|
| Intravenous Ketamine + Mindfulness Exercises | State Mindfulness Scale | 77.68 score on a scale | Standard Deviation 13.74 |
| Intravenous Ketamine + Academic Exercises | State Mindfulness Scale | 83.33 score on a scale | Standard Deviation 15.27 |
Secondary
Daily Spiritual Experience Scale
self-reported spiritual experiences (range: 1-6; higher scores=greater spiritual experience)
Time frame: 21 days post-intervention
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ketamine + Mindfulness Exercises | Daily Spiritual Experience Scale | 2.36 score on a scale | Standard Deviation 1.01 |
| Intravenous Ketamine + Academic Exercises | Daily Spiritual Experience Scale | 2.24 score on a scale | Standard Deviation 1.12 |
Secondary
Daily Spiritual Experience Scale
self-reported spiritual experiences (range: 1-6; higher scores=greater spiritual experience)
Time frame: 5 days post-intervention
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ketamine + Mindfulness Exercises | Daily Spiritual Experience Scale | 2.52 score on a scale | Standard Deviation 0.95 |
| Intravenous Ketamine + Academic Exercises | Daily Spiritual Experience Scale | 2.20 score on a scale | Standard Deviation 0.86 |
Secondary
Daily Spiritual Experience Scale
self-reported spiritual experiences (range: 1-6; higher scores=greater spiritual experience)
Time frame: 30 days post-intervention
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ketamine + Mindfulness Exercises | Daily Spiritual Experience Scale | 2.52 score on a scale | Standard Deviation 1.17 |
| Intravenous Ketamine + Academic Exercises | Daily Spiritual Experience Scale | 2.34 score on a scale | Standard Deviation 0.98 |
Secondary
Daily Spiritual Experience Scale
self-reported spiritual experiences (range: 1-6; higher scores=greater spiritual experience)
Time frame: 12 days post-intervention
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ketamine + Mindfulness Exercises | Daily Spiritual Experience Scale | 2.51 score on a scale | Standard Deviation 1.27 |
| Intravenous Ketamine + Academic Exercises | Daily Spiritual Experience Scale | 2.39 score on a scale | Standard Deviation 1.06 |
Secondary
Hood Mysticism Scale
clinician-administered to assess mystical experiences (range: -64 to +64; higher scores = greater mystical experience)
Time frame: 40 minutes post-intervention
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ketamine + Mindfulness Exercises | Hood Mysticism Scale | -.05 score on a scale | Standard Deviation 5.59 |
| Intravenous Ketamine + Academic Exercises | Hood Mysticism Scale | .05 score on a scale | Standard Deviation 5.7 |
Secondary
Mindful Attention Awareness Scale
self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)
Time frame: 21 days post-intervention
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ketamine + Mindfulness Exercises | Mindful Attention Awareness Scale | 3.79 score on a scale | Standard Deviation 0.73 |
| Intravenous Ketamine + Academic Exercises | Mindful Attention Awareness Scale | 3.86 score on a scale | Standard Deviation 1.04 |
Secondary
Mindful Attention Awareness Scale
self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)
Time frame: 12 days post-intervention
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ketamine + Mindfulness Exercises | Mindful Attention Awareness Scale | 3.90 score on a scale | Standard Deviation 0.92 |
| Intravenous Ketamine + Academic Exercises | Mindful Attention Awareness Scale | 4.09 score on a scale | Standard Deviation 0.87 |
Secondary
Mindful Attention Awareness Scale
self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)
Time frame: 5 days post-intervention
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ketamine + Mindfulness Exercises | Mindful Attention Awareness Scale | 3.90 score on a scale | Standard Deviation 0.8 |
| Intravenous Ketamine + Academic Exercises | Mindful Attention Awareness Scale | 4.15 score on a scale | Standard Deviation 0.96 |
Secondary
Mindful Attention Awareness Scale
self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)
Time frame: 24hrs post-intervention
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ketamine + Mindfulness Exercises | Mindful Attention Awareness Scale | 3.73 score on a scale | Standard Deviation 1.05 |
| Intravenous Ketamine + Academic Exercises | Mindful Attention Awareness Scale | 3.80 score on a scale | Standard Deviation 0.92 |
Secondary
Mindful Attention Awareness Scale
self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)
Time frame: 30 days post-intervention
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ketamine + Mindfulness Exercises | Mindful Attention Awareness Scale | 3.81 score on a scale | Standard Deviation 0.74 |
| Intravenous Ketamine + Academic Exercises | Mindful Attention Awareness Scale | 3.94 score on a scale | Standard Deviation 1.04 |
Secondary
Modified Hamilton Depression Rating Scale
Clinician-rated depression (range: 0-52; higher scores = worse outcome)
Time frame: 30 days post-intervention
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ketamine + Mindfulness Exercises | Modified Hamilton Depression Rating Scale | 12.69 score on a scale | Standard Deviation 7.42 |
| Intravenous Ketamine + Academic Exercises | Modified Hamilton Depression Rating Scale | 12.45 score on a scale | Standard Deviation 6.9 |
Secondary
Modified Hamilton Depression Rating Scale
Clinician-rated depression (range: 0-52; higher scores = worse outcome)
Time frame: 12 days post-intervention
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ketamine + Mindfulness Exercises | Modified Hamilton Depression Rating Scale | 10.67 score on a scale | Standard Deviation 6.3 |
| Intravenous Ketamine + Academic Exercises | Modified Hamilton Depression Rating Scale | 11.11 score on a scale | Standard Deviation 6.32 |
Secondary
Modified Hamilton Depression Rating Scale
Clinician-rated depression (range: 0-52; higher scores = worse outcome)
Time frame: 21 days post-intervention
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ketamine + Mindfulness Exercises | Modified Hamilton Depression Rating Scale | 12.05 score on a scale | Standard Deviation 7.09 |
| Intravenous Ketamine + Academic Exercises | Modified Hamilton Depression Rating Scale | 11.30 score on a scale | Standard Deviation 6.67 |
Secondary
Modified Hamilton Depression Rating Scale
Clinician-rated depression (range: 0-52; higher scores = worse outcome)
Time frame: 24hrs post-intervention
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ketamine + Mindfulness Exercises | Modified Hamilton Depression Rating Scale | 10.00 score on a scale | Standard Deviation 5.17 |
| Intravenous Ketamine + Academic Exercises | Modified Hamilton Depression Rating Scale | 9.55 score on a scale | Standard Deviation 5.5 |
Secondary
Modified Hamilton Depression Rating Scale
Clinician-rated depression (range: 0-52; higher scores = worse outcome)
Time frame: 5 days post-intervention
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ketamine + Mindfulness Exercises | Modified Hamilton Depression Rating Scale | 10.95 score on a scale | Standard Deviation 5.13 |
| Intravenous Ketamine + Academic Exercises | Modified Hamilton Depression Rating Scale | 10.15 score on a scale | Standard Deviation 6.6 |
Secondary
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Time frame: 21 days post-intervention
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ketamine + Mindfulness Exercises | Quick Inventory of Depressive Symptoms | 9.68 score on a scale | Standard Deviation 5.18 |
| Intravenous Ketamine + Academic Exercises | Quick Inventory of Depressive Symptoms | 8.50 score on a scale | Standard Deviation 5.83 |
Secondary
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Time frame: 12 days post-intervention
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ketamine + Mindfulness Exercises | Quick Inventory of Depressive Symptoms | 8.80 score on a scale | Standard Deviation 4.94 |
| Intravenous Ketamine + Academic Exercises | Quick Inventory of Depressive Symptoms | 7.95 score on a scale | Standard Deviation 5.7 |
Secondary
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Time frame: 5 days post-intervention
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ketamine + Mindfulness Exercises | Quick Inventory of Depressive Symptoms | 8.05 score on a scale | Standard Deviation 4.31 |
| Intravenous Ketamine + Academic Exercises | Quick Inventory of Depressive Symptoms | 9.90 score on a scale | Standard Deviation 7.58 |
Secondary
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Time frame: 24hrs post-intervention
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ketamine + Mindfulness Exercises | Quick Inventory of Depressive Symptoms | 6.55 score on a scale | Standard Deviation 5.08 |
| Intravenous Ketamine + Academic Exercises | Quick Inventory of Depressive Symptoms | 6.90 score on a scale | Standard Deviation 5.1 |
Secondary
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Time frame: 30 days post-intervention
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ketamine + Mindfulness Exercises | Quick Inventory of Depressive Symptoms | 9.30 score on a scale | Standard Deviation 5.22 |
| Intravenous Ketamine + Academic Exercises | Quick Inventory of Depressive Symptoms | 8.47 score on a scale | Standard Deviation 4.94 |
Other Pre-specified
Awe Experience Scale
self-report measure of awe-inspiring experiences (range: 30-210; higher score=greater awe)
Time frame: infusion +80min
Other Pre-specified
Dual Probe Video Task
attentional bias (proportion score) towards sad film clips (range: 0-1.0; higher score=greater attention bias towards sad films)
Time frame: infusion +24 hours (1 day)
Other Pre-specified
Pain Rating Via Quantitative Sensory Testing
Pain rating obtained from Quantitative Sensory Testing by mechanical temporal summation (range: 0-10; higher score=more pain)
Time frame: 1-hour post-infusion
Other Pre-specified
PROMIS Pain Intensity Score
PROMIS Pain Intensity Short Form scale T-score (range=0-100; higher score=worse pain)
Time frame: 1-hour post-infusion
Other Pre-specified
PROMIS Pain Interference Score
PROMIS Pain Interference Short Form scale T-score (range=0-100; higher score=worse pain)
Time frame: 1-hour post-infusion
Other Pre-specified
Sustained Attention Response Task (SART) Omission Errors
performance-based measure of mindful attention
Time frame: infusion +24 hours (1 day)
Other Pre-specified
Sustained Attention Response Task (SART) Self-reported Task Focus
self-report rating of being on-task (range: 1-7; higher score=more on-task)
Time frame: infusion +24 hours (1 day)