Trial Outcomes & Findings for Ketamine + Cognitive Training for Suicidality in the Medical Setting: Pilot (NCT NCT04154150)

Results Overview

depression severity; range 0-60; high score=worse outcome

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

16 participants

Primary outcome timeframe

infusion +24 hours

Results posted on

2024-07-22

Participant Flow

Participant milestones

Participant milestones
Measure	Ketamine + Cognitive Training Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training	Ketamine + Sham Training Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training
Overall Study STARTED	7	9
Overall Study COMPLETED	7	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Measure not acquired at baseline from 1 participant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketamine + Cognitive Training n=7 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training	Ketamine + Sham Training n=9 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training	Total n=16 Participants Total of all reporting groups
Age, Continuous	32.29 years STANDARD_DEVIATION 14.80 • n=7 Participants	35.44 years STANDARD_DEVIATION 17.74 • n=9 Participants	34.06 years STANDARD_DEVIATION 16.06 • n=16 Participants
Sex/Gender, Customized Male	2 Participants n=7 Participants	5 Participants n=9 Participants	7 Participants n=16 Participants
Sex/Gender, Customized Female	5 Participants n=7 Participants	3 Participants n=9 Participants	8 Participants n=16 Participants
Sex/Gender, Customized Transgender (female-to-male)	0 Participants n=7 Participants	1 Participants n=9 Participants	1 Participants n=16 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=7 Participants	3 Participants n=9 Participants	4 Participants n=16 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=7 Participants	5 Participants n=9 Participants	11 Participants n=16 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=7 Participants	1 Participants n=9 Participants	1 Participants n=16 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=7 Participants	0 Participants n=9 Participants	0 Participants n=16 Participants
Race (NIH/OMB) Asian	0 Participants n=7 Participants	0 Participants n=9 Participants	0 Participants n=16 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=7 Participants	0 Participants n=9 Participants	0 Participants n=16 Participants
Race (NIH/OMB) Black or African American	2 Participants n=7 Participants	1 Participants n=9 Participants	3 Participants n=16 Participants
Race (NIH/OMB) White	5 Participants n=7 Participants	8 Participants n=9 Participants	13 Participants n=16 Participants
Race (NIH/OMB) More than one race	0 Participants n=7 Participants	0 Participants n=9 Participants	0 Participants n=16 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=7 Participants	0 Participants n=9 Participants	0 Participants n=16 Participants
Montgomery Asberg Depression Rating Scale	39 units on a scale STANDARD_DEVIATION 6.4 • n=7 Participants	36.8 units on a scale STANDARD_DEVIATION 6.3 • n=9 Participants	37.8 units on a scale STANDARD_DEVIATION 6.2 • n=16 Participants
Adult Suicide Ideation Questionnaire	85.0 units on a scale STANDARD_DEVIATION 35.2 • n=6 Participants • Measure not acquired at baseline from 1 participant	96.6 units on a scale STANDARD_DEVIATION 31.5 • n=9 Participants • Measure not acquired at baseline from 1 participant	91.9 units on a scale STANDARD_DEVIATION 32.3 • n=15 Participants • Measure not acquired at baseline from 1 participant
Quick Inventory of Depressive Symptoms	17.8 units on a scale STANDARD_DEVIATION 3.1 • n=6 Participants • Measure not acquired at baseline from 2 participants	14.4 units on a scale STANDARD_DEVIATION 5.95 • n=8 Participants • Measure not acquired at baseline from 2 participants	15.9 units on a scale STANDARD_DEVIATION 5.1 • n=14 Participants • Measure not acquired at baseline from 2 participants
Scale for Suicide Ideation	30.3 units on a scale STANDARD_DEVIATION 2.2 • n=4 Participants • Measure not acquired at baseline from 4 participants	29.3 units on a scale STANDARD_DEVIATION 1.7 • n=8 Participants • Measure not acquired at baseline from 4 participants	29.6 units on a scale STANDARD_DEVIATION 1.8 • n=12 Participants • Measure not acquired at baseline from 4 participants

PRIMARY outcome

Timeframe: infusion +24 hours

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

depression severity; range 0-60; high score=worse outcome

Outcome measures

Outcome measures
Measure	Ketamine + Cognitive Training n=7 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training	Ketamine + Sham Training n=9 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training
Montgomery Asberg Depression Rating Scale	18.43 score on a scale Standard Deviation 8.5	15.44 score on a scale Standard Deviation 10.9

PRIMARY outcome

Timeframe: infusion +5 days

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

depression severity; range 0-60; high score=worse outcome

Outcome measures

Outcome measures
Measure	Ketamine + Cognitive Training n=7 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training	Ketamine + Sham Training n=8 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training
Montgomery Asberg Depression Rating Scale	19.14 score on a scale Standard Deviation 9.8	16.13 score on a scale Standard Deviation 9.2

PRIMARY outcome

Timeframe: infusion +12 days

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

depression severity; range 0-60; high score=worse outcome

Outcome measures

Outcome measures
Measure	Ketamine + Cognitive Training n=3 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training	Ketamine + Sham Training n=7 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training
Montgomery Asberg Depression Rating Scale	13.67 score on a scale Standard Deviation 14.2	17.29 score on a scale Standard Deviation 11.9

PRIMARY outcome

Timeframe: infusion +1 month

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

depression severity; range 0-60; high score=worse outcome

Outcome measures

Outcome measures
Measure	Ketamine + Cognitive Training n=3 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training	Ketamine + Sham Training n=6 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training
Montgomery Asberg Depression Rating Scale	20.67 score on a scale Standard Deviation 7.6	14.00 score on a scale Standard Deviation 13.4

PRIMARY outcome

Timeframe: infusion +3 months

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

depression severity; range 0-60; high score=worse outcome

Outcome measures

Outcome measures
Measure	Ketamine + Cognitive Training n=4 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training	Ketamine + Sham Training n=7 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training
Montgomery Asberg Depression Rating Scale	13.00 score on a scale Standard Deviation 13.6	14.71 score on a scale Standard Deviation 10.2

PRIMARY outcome

Timeframe: infusion +6 months

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

depression severity; range 0-60; high score=worse outcome

Outcome measures

Outcome measures
Measure	Ketamine + Cognitive Training n=5 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training	Ketamine + Sham Training n=7 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training
Montgomery Asberg Depression Rating Scale	13.20 score on a scale Standard Deviation 14.7	17.43 score on a scale Standard Deviation 9.9

PRIMARY outcome

Timeframe: infusion +24 hours

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

suicidal ideation/thoughts; range 0-150; high score=worse outcome

Outcome measures

Outcome measures
Measure	Ketamine + Cognitive Training n=6 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training	Ketamine + Sham Training n=9 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training
Adult Suicide Ideation Questionnaire (Past Day Version)	32.67 score on a scale Standard Deviation 8.45	41.89 score on a scale Standard Deviation 38.6

PRIMARY outcome

Timeframe: infusion +5 days

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

suicidal ideation/thoughts; range 0-150; high score=worse outcome

Outcome measures

Outcome measures
Measure	Ketamine + Cognitive Training n=7 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training	Ketamine + Sham Training n=8 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training
Adult Suicide Ideation Questionnaire (Past Day Version)	20.00 score on a scale Standard Deviation 9.98	22.88 score on a scale Standard Deviation 10.7

PRIMARY outcome

Timeframe: infusion +12 days

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

suicidal ideation/thoughts; range 0-150; high score=worse outcome

Outcome measures

Outcome measures
Measure	Ketamine + Cognitive Training n=6 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training	Ketamine + Sham Training n=7 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training
Adult Suicide Ideation Questionnaire (Past Day Version)	17.17 score on a scale Standard Deviation 13.4	31.86 score on a scale Standard Deviation 34.6

PRIMARY outcome

Timeframe: infusion +1 month

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

suicidal ideation/thoughts; range 0-150; high score=worse outcome

Outcome measures

Outcome measures
Measure	Ketamine + Cognitive Training n=5 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training	Ketamine + Sham Training n=6 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training
Adult Suicide Ideation Questionnaire	23.60 score on a scale Standard Deviation 22.9	41.83 score on a scale Standard Deviation 48.0

PRIMARY outcome

Timeframe: infusion +3 months

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

suicidal ideation/thoughts; range 0-150; high score=worse outcome

Outcome measures

Outcome measures
Measure	Ketamine + Cognitive Training n=5 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training	Ketamine + Sham Training n=6 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training
Adult Suicide Ideation Questionnaire	25.20 score on a scale Standard Deviation 26.2	37.50 score on a scale Standard Deviation 46.5

PRIMARY outcome

Timeframe: infusion +6 months

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

suicidal ideation/thoughts; range 0-150; high score=worse outcome

Outcome measures

Outcome measures
Measure	Ketamine + Cognitive Training n=4 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training	Ketamine + Sham Training n=4 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training
Adult Suicide Ideation Questionnaire	29.5 score on a scale Standard Deviation 40.3	45.75 score on a scale Standard Deviation 60.9

SECONDARY outcome

Timeframe: infusion +6 months

Population: All participants who were assigned to the arm.

Number of participants with occurrence of any suicidal act (derived from medical chart) including: re-attempt, re-hospitalization for suicidality, or completed suicide

Outcome measures

Outcome measures
Measure	Ketamine + Cognitive Training n=7 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training	Ketamine + Sham Training n=9 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training
Number of Participants With Occurrence of Suicidal Behaviors Per Medical Chart Review	3 Participants	4 Participants

SECONDARY outcome

Timeframe: infusion +6 months

Population: All participants who were assigned to the arm and were willing and able to complete at least one CSSRS interview at any point during follow-up.

Number of participants with occurrence of any suicidal act (derived from Columbia Suicide Severity Rating Scale interview; each of the following items was scored yes/no for the period since last assessment: re-attempt, re-hospitalization for suicidality, or completed suicide. Analyzed outcome measure is # of participants with 1 or more 'yes' responses.

Outcome measures

Outcome measures
Measure	Ketamine + Cognitive Training n=6 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training	Ketamine + Sham Training n=8 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training
Number of Participants Reporting Suicidal Behaviors Per the Columbia Suicide Severity Rating Scale (CSSRS)	1 Participants	1 Participants

SECONDARY outcome

Timeframe: infusion +24 hours

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

Outcome measures
Measure	Ketamine + Cognitive Training n=6 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training	Ketamine + Sham Training n=9 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training
Quick Inventory of Depressive Symptoms	12.83 score on a scale Standard Deviation 4.1	11.22 score on a scale Standard Deviation 6.0

SECONDARY outcome

Timeframe: infusion +5 days

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

Outcome measures
Measure	Ketamine + Cognitive Training n=7 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training	Ketamine + Sham Training n=8 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training
Quick Inventory of Depressive Symptoms	9.86 score on a scale Standard Deviation 5.8	9.50 score on a scale Standard Deviation 6.9

SECONDARY outcome

Timeframe: infusion +12 days

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

Outcome measures
Measure	Ketamine + Cognitive Training n=6 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training	Ketamine + Sham Training n=7 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training
Quick Inventory of Depressive Symptoms	8.33 score on a scale Standard Deviation 7.1	9.86 score on a scale Standard Deviation 7.3

SECONDARY outcome

Timeframe: infusion +1 month

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

Outcome measures
Measure	Ketamine + Cognitive Training n=5 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training	Ketamine + Sham Training n=6 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training
Quick Inventory of Depressive Symptoms	9.60 score on a scale Standard Deviation 3.4	9.33 score on a scale Standard Deviation 7.0

SECONDARY outcome

Timeframe: infusion +3 months

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

Outcome measures
Measure	Ketamine + Cognitive Training n=5 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training	Ketamine + Sham Training n=6 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training
Quick Inventory of Depressive Symptoms	10.60 score on a scale Standard Deviation 7.1	9.17 score on a scale Standard Deviation 7.5

SECONDARY outcome

Timeframe: infusion +6 months

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

Outcome measures
Measure	Ketamine + Cognitive Training n=4 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training	Ketamine + Sham Training n=4 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training
Quick Inventory of Depressive Symptoms	10.00 score on a scale Standard Deviation 10.0	12.25 score on a scale Standard Deviation 10.6

SECONDARY outcome

Timeframe: infusion +24 hours

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure. Measure added to protocol after first 4 patients.

suicidal ideation/thoughts; range 0-38; high score=worse outcome

Outcome measures

Outcome measures
Measure	Ketamine + Cognitive Training n=2 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training	Ketamine + Sham Training n=5 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training
Scale for Suicide Ideation	8.50 score on a scale Standard Deviation 12.0	0.80 score on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: infusion +5 days

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure. Measure added to protocol after first 4 patients.

suicidal ideation/thoughts; range 0-38; high score=worse outcome

Outcome measures

Outcome measures
Measure	Ketamine + Cognitive Training n=2 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training	Ketamine + Sham Training n=5 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training
Scale for Suicide Ideation	0.50 score on a scale Standard Deviation .71	6.60 score on a scale Standard Deviation 9.4

SECONDARY outcome

Timeframe: infusion +12 days

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure. Measure added to protocol after first 4 patients.

suicidal ideation/thoughts; range 0-38; high score=worse outcome

Outcome measures

Outcome measures
Measure	Ketamine + Cognitive Training Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training	Ketamine + Sham Training n=4 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training
Scale for Suicide Ideation	—	4.50 score on a scale Standard Deviation 9.0

SECONDARY outcome

Timeframe: infusion +1 month

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure. Measure added to protocol after first 4 patients.

suicidal ideation/thoughts; range 0-38; high score=worse outcome

Outcome measures

Outcome measures
Measure	Ketamine + Cognitive Training n=1 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training	Ketamine + Sham Training n=3 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training
Scale for Suicide Ideation	13.00 score on a scale	4.67 score on a scale Standard Deviation 7.2

SECONDARY outcome

Timeframe: infusion +3 months

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure. Measure added to protocol after first 4 patients.

suicidal ideation/thoughts; range 0-38; high score=worse outcome

Outcome measures

Outcome measures
Measure	Ketamine + Cognitive Training n=4 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training	Ketamine + Sham Training n=6 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training
Scale for Suicide Ideation	4.00 score on a scale Standard Deviation 7.3	5.83 score on a scale Standard Deviation 9.2

SECONDARY outcome

Timeframe: infusion +6 months

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure. Measure added to protocol after first 4 patients.

suicidal ideation/thoughts; range 0-38; high score=worse outcome

Outcome measures

Outcome measures
Measure	Ketamine + Cognitive Training n=5 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training	Ketamine + Sham Training n=7 Participants Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training
Scale for Suicide Ideation	5.40 score on a scale Standard Deviation 12.1	6.86 score on a scale Standard Deviation 9.2

Adverse Events

Ketamine + Cognitive Training

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Ketamine + Sham Training

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Rebecca Price

University of Pittsburgh

Phone: 412-383-2150

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Ketamine + Cognitive Training n=7 participants at risk Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training	Ketamine + Sham Training n=9 participants at risk Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training
Psychiatric disorders anxiety	28.6% 2/7 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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% 3/9 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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 constipation	28.6% 2/7 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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.	22.2% 2/9 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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	14.3% 1/7 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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.	22.2% 2/9 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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	0.00% 0/7 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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.	11.1% 1/9 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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	42.9% 3/7 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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% 3/9 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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	0.00% 0/7 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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.	11.1% 1/9 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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	28.6% 2/7 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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.	22.2% 2/9 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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	14.3% 1/7 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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.	11.1% 1/9 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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	42.9% 3/7 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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.	22.2% 2/9 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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 feeling 'high'	14.3% 1/7 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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% 0/9 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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	28.6% 2/7 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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% 3/9 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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	14.3% 1/7 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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.	22.2% 2/9 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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	0.00% 0/7 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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.	11.1% 1/9 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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	42.9% 3/7 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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% 0/9 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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	14.3% 1/7 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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.	22.2% 2/9 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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	28.6% 2/7 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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% 3/9 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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	0.00% 0/7 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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.	11.1% 1/9 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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	0.00% 0/7 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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.	11.1% 1/9 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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.