Trial Outcomes & Findings for Ketamine + Mindfulness for Depression (NCT NCT05168735)

NCT ID: NCT05168735

Last Updated: 2024-08-20

Results Overview

Clinician-rated depression (range: 0-60; higher scores = worse outcome)

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 43 participants
• Primary outcome timeframe: 24hrs post-intervention
• Results posted on: 2024-08-20

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	22	21
Overall Study COMPLETED	22	21
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ketamine + Mindfulness for Depression

Baseline characteristics by cohort

Measure	Intravenous Ketamine + Mindfulness Exercises n=22 Participants 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	Intravenous Ketamine + Academic Exercises n=21 Participants 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	Total n=43 Participants Total of all reporting groups
Age, Continuous	40.00 years STANDARD_DEVIATION 13.82 • n=5 Participants	36.05 years STANDARD_DEVIATION 30.29 • n=7 Participants	38.07 years STANDARD_DEVIATION 13.51 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Montgomery Asberg Depression Rating Scale	30.64 units on a scale STANDARD_DEVIATION 6.27 • n=5 Participants	30.29 units on a scale STANDARD_DEVIATION 6.21 • n=7 Participants	30.47 units on a scale STANDARD_DEVIATION 6.17 • n=5 Participants

PRIMARY outcome

Timeframe: 24hrs post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Clinician-rated depression (range: 0-60; higher scores = worse outcome)

Outcome measures

Measure	Intravenous Ketamine + Mindfulness Exercises n=20 Participants 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	Intravenous Ketamine + Academic Exercises n=20 Participants 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
Montgomery-Asberg Depression Rating Scale	12.50 score on a scale Standard Deviation 7.94	13.30 score on a scale Standard Deviation 8.90

PRIMARY outcome

Timeframe: 5 days post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Clinician-rated depression (range: 0-60; higher scores = worse outcome)

Outcome measures

Measure	Intravenous Ketamine + Mindfulness Exercises n=21 Participants 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	Intravenous Ketamine + Academic Exercises n=20 Participants 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
Montgomery-Asberg Depression Rating Scale	15.81 score on a scale Standard Deviation 7.84	14.30 score on a scale Standard Deviation 10.69

PRIMARY outcome

Timeframe: 12 days post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Clinician-rated depression (range: 0-60; higher scores = worse outcome)

Outcome measures

Measure	Intravenous Ketamine + Mindfulness Exercises n=21 Participants 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	Intravenous Ketamine + Academic Exercises n=19 Participants 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
Montgomery-Asberg Depression Rating Scale	15.43 score on a scale Standard Deviation 8.42	17.21 score on a scale Standard Deviation 11.74

PRIMARY outcome

Timeframe: 21 days post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Clinician-rated depression (range: 0-60; higher scores = worse outcome)

Outcome measures

Measure	Intravenous Ketamine + Mindfulness Exercises n=19 Participants 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	Intravenous Ketamine + Academic Exercises n=20 Participants 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
Montgomery-Asberg Depression Rating Scale	18.90 score on a scale Standard Deviation 11.71	17.10 score on a scale Standard Deviation 11.39

PRIMARY outcome

Timeframe: 30 days post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Clinician-rated depression (range: 0-60; higher scores = worse outcome)

Outcome measures

Measure	Intravenous Ketamine + Mindfulness Exercises n=20 Participants 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	Intravenous Ketamine + Academic Exercises n=20 Participants 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
Montgomery-Asberg Depression Rating Scale	18.55 score on a scale Standard Deviation 12.02	20.05 score on a scale Standard Deviation 11.64

PRIMARY outcome

Timeframe: 80min post-infusion

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Self-reported mindfulness (range 21-105; higher scores = more mindfulness)

Outcome measures

Measure	Intravenous Ketamine + Mindfulness Exercises n=22 Participants 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	Intravenous Ketamine + Academic Exercises n=21 Participants 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
State Mindfulness Scale	77.68 score on a scale Standard Deviation 13.74	83.33 score on a scale Standard Deviation 15.27

SECONDARY outcome

Timeframe: 24hrs post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Clinician-rated depression (range: 0-52; higher scores = worse outcome)

Outcome measures

Measure	Intravenous Ketamine + Mindfulness Exercises n=20 Participants 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	Intravenous Ketamine + Academic Exercises n=20 Participants 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
Modified Hamilton Depression Rating Scale	10.00 score on a scale Standard Deviation 5.17	9.55 score on a scale Standard Deviation 5.50

SECONDARY outcome

Timeframe: 5 days post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Clinician-rated depression (range: 0-52; higher scores = worse outcome)

Outcome measures

Measure	Intravenous Ketamine + Mindfulness Exercises n=21 Participants 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	Intravenous Ketamine + Academic Exercises n=20 Participants 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
Modified Hamilton Depression Rating Scale	10.95 score on a scale Standard Deviation 5.13	10.15 score on a scale Standard Deviation 6.60

SECONDARY outcome

Timeframe: 12 days post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Clinician-rated depression (range: 0-52; higher scores = worse outcome)

Outcome measures

Measure	Intravenous Ketamine + Mindfulness Exercises n=21 Participants 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	Intravenous Ketamine + Academic Exercises n=19 Participants 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
Modified Hamilton Depression Rating Scale	10.67 score on a scale Standard Deviation 6.30	11.11 score on a scale Standard Deviation 6.32

SECONDARY outcome

Timeframe: 21 days post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Clinician-rated depression (range: 0-52; higher scores = worse outcome)

Outcome measures

Measure	Intravenous Ketamine + Mindfulness Exercises n=19 Participants 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	Intravenous Ketamine + Academic Exercises n=20 Participants 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
Modified Hamilton Depression Rating Scale	12.05 score on a scale Standard Deviation 7.09	11.30 score on a scale Standard Deviation 6.67

SECONDARY outcome

Timeframe: 30 days post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Clinician-rated depression (range: 0-52; higher scores = worse outcome)

Outcome measures

Measure	Intravenous Ketamine + Mindfulness Exercises n=20 Participants 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	Intravenous Ketamine + Academic Exercises n=20 Participants 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
Modified Hamilton Depression Rating Scale	12.69 score on a scale Standard Deviation 7.42	12.45 score on a scale Standard Deviation 6.90

SECONDARY outcome

Timeframe: 24hrs post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Self-reported depression (range: 0-27; higher scores = worse outcome)

Outcome measures

Measure	Intravenous Ketamine + Mindfulness Exercises n=20 Participants 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	Intravenous Ketamine + Academic Exercises n=20 Participants 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
Quick Inventory of Depressive Symptoms	6.55 score on a scale Standard Deviation 5.08	6.90 score on a scale Standard Deviation 5.10

SECONDARY outcome

Timeframe: 5 days post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Self-reported depression (range: 0-27; higher scores = worse outcome)

Outcome measures

Measure	Intravenous Ketamine + Mindfulness Exercises n=19 Participants 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	Intravenous Ketamine + Academic Exercises n=19 Participants 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
Quick Inventory of Depressive Symptoms	8.05 score on a scale Standard Deviation 4.31	9.90 score on a scale Standard Deviation 7.58

SECONDARY outcome

Timeframe: 12 days post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Self-reported depression (range: 0-27; higher scores = worse outcome)

Outcome measures

Measure	Intravenous Ketamine + Mindfulness Exercises n=20 Participants 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	Intravenous Ketamine + Academic Exercises n=19 Participants 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
Quick Inventory of Depressive Symptoms	8.80 score on a scale Standard Deviation 4.94	7.95 score on a scale Standard Deviation 5.70

SECONDARY outcome

Timeframe: 21 days post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Self-reported depression (range: 0-27; higher scores = worse outcome)

Outcome measures

Measure	Intravenous Ketamine + Mindfulness Exercises n=19 Participants 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	Intravenous Ketamine + Academic Exercises n=18 Participants 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
Quick Inventory of Depressive Symptoms	9.68 score on a scale Standard Deviation 5.18	8.50 score on a scale Standard Deviation 5.83

SECONDARY outcome

Timeframe: 30 days post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Self-reported depression (range: 0-27; higher scores = worse outcome)

Outcome measures

Measure	Intravenous Ketamine + Mindfulness Exercises n=20 Participants 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	Intravenous Ketamine + Academic Exercises n=17 Participants 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
Quick Inventory of Depressive Symptoms	9.30 score on a scale Standard Deviation 5.22	8.47 score on a scale Standard Deviation 4.94

SECONDARY outcome

Timeframe: 40 minutes post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

clinician-administered to assess mystical experiences (range: -64 to +64; higher scores = greater mystical experience)

Outcome measures

Measure	Intravenous Ketamine + Mindfulness Exercises n=22 Participants 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	Intravenous Ketamine + Academic Exercises n=21 Participants 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
Hood Mysticism Scale	-.05 score on a scale Standard Deviation 5.59	.05 score on a scale Standard Deviation 5.70

SECONDARY outcome

Timeframe: 24hrs post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)

Outcome measures

Measure	Intravenous Ketamine + Mindfulness Exercises n=20 Participants 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	Intravenous Ketamine + Academic Exercises n=20 Participants 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
Mindful Attention Awareness Scale	3.73 score on a scale Standard Deviation 1.05	3.80 score on a scale Standard Deviation .92

SECONDARY outcome

Timeframe: 5 days post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)

Outcome measures

Measure	Intravenous Ketamine + Mindfulness Exercises n=21 Participants 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	Intravenous Ketamine + Academic Exercises n=19 Participants 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
Mindful Attention Awareness Scale	3.90 score on a scale Standard Deviation .80	4.15 score on a scale Standard Deviation .96

SECONDARY outcome

Timeframe: 12 days post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)

Outcome measures

Measure	Intravenous Ketamine + Mindfulness Exercises n=20 Participants 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	Intravenous Ketamine + Academic Exercises n=19 Participants 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
Mindful Attention Awareness Scale	3.90 score on a scale Standard Deviation .92	4.09 score on a scale Standard Deviation .87

SECONDARY outcome

Timeframe: 21 days post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)

Outcome measures

Measure	Intravenous Ketamine + Mindfulness Exercises n=20 Participants 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	Intravenous Ketamine + Academic Exercises n=18 Participants 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
Mindful Attention Awareness Scale	3.79 score on a scale Standard Deviation .73	3.86 score on a scale Standard Deviation 1.04

SECONDARY outcome

Timeframe: 30 days post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness)

Outcome measures

Measure	Intravenous Ketamine + Mindfulness Exercises n=20 Participants 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	Intravenous Ketamine + Academic Exercises n=17 Participants 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
Mindful Attention Awareness Scale	3.81 score on a scale Standard Deviation .74	3.94 score on a scale Standard Deviation 1.04

SECONDARY outcome

Timeframe: 5 days post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

self-reported spiritual experiences (range: 1-6; higher scores=greater spiritual experience)

Outcome measures

Measure	Intravenous Ketamine + Mindfulness Exercises n=20 Participants 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	Intravenous Ketamine + Academic Exercises n=19 Participants 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
Daily Spiritual Experience Scale	2.52 score on a scale Standard Deviation .95	2.20 score on a scale Standard Deviation .86

SECONDARY outcome

Timeframe: 12 days post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

self-reported spiritual experiences (range: 1-6; higher scores=greater spiritual experience)

Outcome measures

Measure	Intravenous Ketamine + Mindfulness Exercises n=20 Participants 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	Intravenous Ketamine + Academic Exercises n=19 Participants 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
Daily Spiritual Experience Scale	2.51 score on a scale Standard Deviation 1.27	2.39 score on a scale Standard Deviation 1.06

SECONDARY outcome

Timeframe: 21 days post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

self-reported spiritual experiences (range: 1-6; higher scores=greater spiritual experience)

Outcome measures

Measure	Intravenous Ketamine + Mindfulness Exercises n=20 Participants 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	Intravenous Ketamine + Academic Exercises n=18 Participants 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
Daily Spiritual Experience Scale	2.36 score on a scale Standard Deviation 1.01	2.24 score on a scale Standard Deviation 1.12

SECONDARY outcome

Timeframe: 30 days post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

self-reported spiritual experiences (range: 1-6; higher scores=greater spiritual experience)

Outcome measures

Measure	Intravenous Ketamine + Mindfulness Exercises n=20 Participants 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	Intravenous Ketamine + Academic Exercises n=17 Participants 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
Daily Spiritual Experience Scale	2.52 score on a scale Standard Deviation 1.17	2.34 score on a scale Standard Deviation .98

OTHER_PRE_SPECIFIED outcome

Timeframe: infusion +24 hours (1 day)

performance-based measure of mindful attention

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: infusion +24 hours (1 day)

self-report rating of being on-task (range: 1-7; higher score=more on-task)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: infusion +80min

self-report measure of awe-inspiring experiences (range: 30-210; higher score=greater awe)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1-hour post-infusion

Pain rating obtained from Quantitative Sensory Testing by mechanical temporal summation (range: 0-10; higher score=more pain)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1-hour post-infusion

PROMIS Pain Intensity Short Form scale T-score (range=0-100; higher score=worse pain)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1-hour post-infusion

PROMIS Pain Interference Short Form scale T-score (range=0-100; higher score=worse pain)

Outcome measures

Outcome data not reported

Adverse Events

Intravenous Ketamine + Mindfulness Exercises

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Intravenous Ketamine + Academic Exercises

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intravenous Ketamine + Mindfulness Exercises n=22 participants at risk 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	Intravenous Ketamine + Academic Exercises n=21 participants at risk 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
Psychiatric disorders anxiety	9.1% 2/22 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.	4.8% 1/21 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
General disorders decreased energy	13.6% 3/22 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.	33.3% 7/21 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
Gastrointestinal disorders diarrhea	27.3% 6/22 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.	4.8% 1/21 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
Psychiatric disorders difficulty sleeping: too little	18.2% 4/22 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.	9.5% 2/21 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
Psychiatric disorders difficulty sleeping: too much	9.1% 2/22 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.	4.8% 1/21 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
Psychiatric disorders dissociative symptoms	90.9% 20/22 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.	100.0% 21/21 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
Nervous system disorders dizziness	40.9% 9/22 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.	66.7% 14/21 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
Gastrointestinal disorders dry mouth	31.8% 7/22 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.	42.9% 9/21 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
Vascular disorders elevated blood pressure	4.5% 1/22 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.	0.00% 0/21 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
Psychiatric disorders emotional indifference	13.6% 3/22 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.	4.8% 1/21 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
Nervous system disorders headache	18.2% 4/22 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.	23.8% 5/21 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
Gastrointestinal disorders increased appetite	45.5% 10/22 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.	33.3% 7/21 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
Metabolism and nutrition disorders increased weight	13.6% 3/22 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.	0.00% 0/21 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
Reproductive system and breast disorders loss of sexual desire	13.6% 3/22 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.	0.00% 0/21 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
Gastrointestinal disorders nausea	18.2% 4/22 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.	28.6% 6/21 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
Cardiac disorders palpitations	18.2% 4/22 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.	9.5% 2/21 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
General disorders restlessness	22.7% 5/22 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.	14.3% 3/21 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
General disorders sweating	22.7% 5/22 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.	4.8% 1/21 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
Nervous system disorders tremors	4.5% 1/22 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.	4.8% 1/21 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
Reproductive system and breast disorders trouble achieving orgasm	9.1% 2/22 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.	4.8% 1/21 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.

Additional Information

Dr. Rebecca Price

University of Pittsburgh

Phone: 412-383-2150

Email: pricerb@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place