CompletedNCT03237286Updated Mar 19, 2024Results posted

Intravenous Ketamine Plus Neurocognitive Training for Depression

A Phase 1/2 interventional study of Intravenous ketamine and Computer-based Cognitive Training in Depression, sponsored by Rebecca Price. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-03-19.

Sponsored by Rebecca Price · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 154
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: All

Study summary

This study has two aims: 1) to characterize the effects of intravenous ketamine on neurocognitive markers in depressed patients; 2) to test the efficacy of a synergistic intervention for depression combining intravenous ketamine with neurocognitive training. Three of the primary outcomes listed (fMRI functional connectivity; Implicit Association Test; cognitive flexibility testing) pertain to Aim 1. For Aim 2, one primary clinical outcome (MADRS, a clinician-administered measure of depression severity) pertains to the acute (30-day) phase, while the QIDS (a self-report measure of depression severity) becomes the primary clinical outcome during the 12-month naturalistic follow-up.

Read the detailed description

This study measures clinical and mechanistic outcome trajectories following ketamine (with or without adjunctive neurocognitive training) measured over an acute (30-day) period; and subsequently (for a subset of measures) over a 12-month naturalistic follow-up period.

NOTE: Corrections have been made to the "Time Frame" entries for all primary/secondary outcomes after identifying errors stemming from the study team's misunderstanding of the "Time Frame" query. Initially, the "Time Frame" query was misinterpreted to mean the range (minimum to maximum) length of the time interval over which any given assessment visit might query symptoms, and were therefore assigned erroneous values ("1 day to 2 weeks"; "1 day to lifetime") reflecting the time interval(s) queried by the instrument (e.g. at the +24 hours timepoint, symptoms are queried over a 1-day interval; at other assessment points, they could be queried over a 2-week interval for some measures, or over the entire lifetime for other measures). After recognizing this misinterpretation, the values have been adjusted to accurately reflect the a priori analytic plan.

Conditions studied

Depression

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Keywords

depression
ketamine
neurocognitive
fMRI
cognitive training

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 154 is above the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Rebecca Price is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Participants will:

be between the ages of 18 and 60 years,
have not responded to one or more adequate trials of FDA-approved antidepressants within the current depressive episode, determined by Antidepressant Treatment History Form
score ≥ 25 on the Montgomery Asberg Depression Rating Scale (MADRS)
score >1SD above the normative mean on the Cognitive Triad Inventory "self" subscale *OR* \<1SD below the normative mean on the Rosenberg self-esteem scale
possess a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document
agree to sign a release of information (ROI), identifying another individual [friend, family member, etc.] as a contact person while the patient is enrolled in the study.

Exclusion criteria

Exclusion Criteria:

Presence of lifetime bipolar, psychotic, or autism spectrum; current problematic substance use (e.g., substance use disorder); or lifetime recreational ketamine or PCP use
Use of a Monoamine Oxidase Inhibitor (MAOI) within the previous 2 weeks
Failure to meet standard MRI inclusion criteria: those who have cardiac pacemakers, neural pacemakers, cochlear implants, metal braces, or other non-MRI-compatible metal objects in their body, especially in the eye. Dental fillings do not present a problem. Plastic or removable dental appliances do not require exclusion. History of significant injury or surgery to the brain or spinal cord that would impair interpretation of results.
Current pregnancy or breastfeeding, or failure to engage in an effective birth control strategy throughout the duration of the study
Acute suicidality or other psychiatric crises requiring treatment escalation.
Changes made to treatment regimen within 4 weeks of baseline assessment
Reading level \<6th grade
For study entry, patients must be reasonable medical candidates for ketamine infusion, as determined by a board-certified physician co-investigator during study screening. Serious, unstable medical illnesses including respiratory [obstructive sleep apnea, or history of difficulty with airway management during previous anesthetics], cardiovascular [including ischemic heart disease and uncontrolled hypertension], and neurologic [including history of severe head injury] will be exclusions.
Clinically significant abnormal findings of laboratory parameters [including urine toxicology screen for drugs of abuse], physical examination, or ECG.
Uncontrolled or poorly controlled hypertension, as determined by a board-certified physician co-investigator's review of vitals collected during screening and any other relevant medical history/records.
Patients with one or more seizures without a clear and resolved etiology.
Patients starting hormonal treatment (e.g., estrogen) in the 3 months prior to Screening. Birth control is not an exclusion.
Past intolerance or hypersensitivity to ketamine or midazolam.
Patients taking medications with known activity at the NMDA or AMPA glutamate receptor [e.g., riluzole, amantadine, lamotrigine, memantine, topiramate, dextromethorphan, D-cycloserine], or the muopioid receptor.
Patients taking any of the following medications: St John's Wort, theophylline, tramadol, metrizamide
Patients who have received ECT in the past 6 months prior to Screening.
Patients currently receiving treatment with vagus nerve stimulation (VNS) or repetitive transcranial stimulation (rTMS).
Patients taking benzodiazepines (within 8 hours of infusion) or GABA agonists

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 154 participants (actual)

Study arms

Experimental
Ketamine + Cognitive Training
Drug: Intravenous ketamine · Behavioral: Computer-based Cognitive Training
Sham comparator
Ketamine + Sham Training
Drug: Intravenous ketamine
Placebo comparator
Saline + Cognitive Training
Behavioral: Computer-based Cognitive Training

Interventions

DrugIntravenous ketamine
Intravenous ketamine is given at a subanesthetic dose, which previous research suggests is safe and efficacious for rapid relief from depression.
BehavioralComputer-based Cognitive Training
Computer-based Cognitive Training will be delivered following intravenous ketamine to test whether learning during a post-ketamine "window of opportunity" might extend relief from depression.

What researchers measure

Primary outcomes

Montgomery Asberg Depression Scale
Clinician-rated depression (range: 0-60; higher scores = worse outcome)
Time frame: Trajectories from 24 hours through Day 30 post-infusion, Day 30 reported
Executive-salience Network Functional Connectivity
fMRI measure (beta weights where larger beta weight = stronger connectivity)
Time frame: Trajectories from 24 hours through Day 30 post-infusion, 24 hours reported
Implicit Self-representations
Implicit Association Test composite difference score (performance-based measure; range = -inf-inf; high score=worse outcome; negatively signed value indicates associating oneself more strongly with positive than negative attributes)
Time frame: Trajectories from 24 hours through Day 30 post-infusion, Day 5 reported
Cognitive Flexibility
Neurocognitive testing via NIH Toolbox DCCS fully-corrected T-scores (range = 0-100; high score=better outcome)
Time frame: Trajectories from 24 hours through Day 30 post-infusion, Day 30 reported
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Time frame: Trajectories from Day 30 through 12 months post-infusion (naturalistic follow-up), Month 12 reported

Secondary outcomes

Executive-salience Network Functional Connectivity During Resting State
fMRI measure (beta weights where larger beta weight = stronger connectivity)
Time frame: Trajectories from 24 hours through Day 30 post-infusion, 24 hours reported
Affective Flexibility
'D-Prime' discrimination Z-score measured via accuracy of responses during the Affective Go/No-Go task (range: -inf-inf; high score=better performance; Z-score of 0=the sample mean)
Time frame: Trajectories from 24 hours through Day 30 post-infusion, Day 30 reported
PROMIS Measures-depression
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported depression T-score range: 0-100 (higher score = worse outcome)
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
PROMIS Measures-anxiety
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported anxiety T-score range: 0-100 (higher score = worse outcome)
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
PROMIS Measures-anger
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported anger T-score range: 0-100 (higher score = worse outcome)
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
PROMIS Measures-positive Affect
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported positive affect/well-being T-score range: 0-100 (higher score = better outcome)
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
PROMIS Measures-sleep Disturbance
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported sleep disturbance T-score range: 0-100 (higher score = worse outcome)
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
PROMIS Measures-cognitive Function
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported cognitive function T-score range: 0-100 (higher score = better outcome)
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
PROMIS Measures-substance Use
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported substance use Raw score range: 0-35 (higher score = worse outcome)
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
PROMIS Measures-alcohol
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported alcohol use T-score range: 0-100 (higher score = worse outcome)
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Cognitive Triad Inventory
Negative perceptions of self, future, \& world (range=36-252; higher score = better outcome)
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Columbia-Suicide Severity Rating Scale
Suicidality and patient safety (most severe ideation score, range=0-5; higher score = worse outcome)
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
WHO Disability Assessment Scale (SR)
Global functioning (range=0-48; higher score = worse outcome)
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Cognitive Flexibility Scale
Self-reported cognitive flexibility (range=12-72; higher score = better outcome)
Time frame: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Neuroplasticity-related Markers in Blood
ketamine metabolite (2R,6R)-HNK concentration levels (range=0-inf; higher score = greater concentration in blood)
Time frame: 40min post-infusion

Results

Posted Nov 1, 2023

Participant flow

Participant flow — Overall Study
Milestone	Ketamine + Cognitive Training	Ketamine + Sham Training	Saline + Cognitive Training
Started	53	50	51
Completed	52	50	48
Not completed	1	0	3
Withdrew: Withdrawal by subject	1	0	2
Withdrew: Study withdrew participant due to repeated non-compliance	0	0	1

Outcome measures

PrimaryMontgomery Asberg Depression Scale

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

Time frame:: Trajectories from 24 hours through Day 30 post-infusion, Day 30 reported
Reported as:: Mean · score on a scale

Montgomery Asberg Depression Scale
score on a scale	Ketamine + Cognitive Training	Ketamine + Sham Training	Saline + Cognitive Training
Montgomery Asberg Depression Scale	19.72 ± 10.20	22.87 ± 11.63	23.51 ± 9.66

Statistical analysis

Ketamine + Cognitive Training vs Saline + Cognitive Training · Regression, Linear · p = .0004

PrimaryExecutive-salience Network Functional Connectivity

fMRI measure (beta weights where larger beta weight = stronger connectivity)

Time frame:: Trajectories from 24 hours through Day 30 post-infusion, 24 hours reported
Reported as:: Mean · beta weights

Executive-salience Network Functional Connectivity
beta weights	Ketamine + Cognitive Training	Ketamine + Sham Training	Saline + Cognitive Training
Executive-salience Network Functional Connectivity	0.55 ± 0.11	0.59 ± 0.11	0.57 ± 0.10

PrimaryImplicit Self-representations

Implicit Association Test composite difference score (performance-based measure; range = -inf-inf; high score=worse outcome; negatively signed value indicates associating oneself more strongly with positive than negative attributes)

Time frame:: Trajectories from 24 hours through Day 30 post-infusion, Day 5 reported
Reported as:: Mean · factor score

Implicit Self-representations
factor score	Ketamine + Cognitive Training	Ketamine + Sham Training	Saline + Cognitive Training
Implicit Self-representations	-.16 ± 1.00	0.15 ± 1.03	0.03 ± 0.97

PrimaryCognitive Flexibility

Neurocognitive testing via NIH Toolbox DCCS fully-corrected T-scores (range = 0-100; high score=better outcome)

Time frame:: Trajectories from 24 hours through Day 30 post-infusion, Day 30 reported
Reported as:: Mean · score on a scale

Cognitive Flexibility
score on a scale	Ketamine + Cognitive Training	Ketamine + Sham Training	Saline + Cognitive Training
Cognitive Flexibility	54.51 ± 13.33	49.34 ± 12.48	53.25 ± 12.98

PrimaryQuick Inventory of Depressive Symptoms

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

Time frame:: Trajectories from Day 30 through 12 months post-infusion (naturalistic follow-up), Month 12 reported
Reported as:: Mean · score on a scale

Quick Inventory of Depressive Symptoms
score on a scale	Ketamine + Cognitive Training	Ketamine + Sham Training	Saline + Cognitive Training
Quick Inventory of Depressive Symptoms	10.77 ± 6.84	12.03 ± 5.94	10.42 ± 4.38

SecondaryExecutive-salience Network Functional Connectivity During Resting State

fMRI measure (beta weights where larger beta weight = stronger connectivity)

Time frame:: Trajectories from 24 hours through Day 30 post-infusion, 24 hours reported
Reported as:: Mean · beta weights

Executive-salience Network Functional Connectivity During Resting State
beta weights	Ketamine + Cognitive Training	Ketamine + Sham Training	Saline + Cognitive Training
Executive-salience Network Functional Connectivity During Resting State	0.53 ± 0.10	0.50 ± 0.09	0.51 ± 0.12

SecondaryAffective Flexibility

'D-Prime' discrimination Z-score measured via accuracy of responses during the Affective Go/No-Go task (range: -inf-inf; high score=better performance; Z-score of 0=the sample mean)

Time frame:: Trajectories from 24 hours through Day 30 post-infusion, Day 30 reported
Reported as:: Mean · Z-score

Affective Flexibility
Z-score	Ketamine + Cognitive Training	Ketamine + Sham Training	Saline + Cognitive Training
Affective Flexibility	-.18 ± 1.71	-.07 ± 1.52	0.26 ± 1.62

SecondaryPROMIS Measures-depression

Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported depression T-score range: 0-100 (higher score = worse outcome)

Time frame:: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Reported as:: Mean · score on a scale

PROMIS Measures-depression
score on a scale	Ketamine + Cognitive Training	Ketamine + Sham Training	Saline + Cognitive Training
PROMIS Measures-depression	58.97 ± 12.15	61.01 ± 9.54	57.13 ± 9.57

SecondaryPROMIS Measures-anxiety

Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported anxiety T-score range: 0-100 (higher score = worse outcome)

Time frame:: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Reported as:: Mean · score on a scale

PROMIS Measures-anxiety
score on a scale	Ketamine + Cognitive Training	Ketamine + Sham Training	Saline + Cognitive Training
PROMIS Measures-anxiety	58.07 ± 9.42	62.49 ± 9.26	57.88 ± 8.87

SecondaryPROMIS Measures-anger

Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported anger T-score range: 0-100 (higher score = worse outcome)

Time frame:: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Reported as:: Mean · score on a scale

PROMIS Measures-anger
score on a scale	Ketamine + Cognitive Training	Ketamine + Sham Training	Saline + Cognitive Training
PROMIS Measures-anger	50.27 ± 13.03	54.21 ± 10.44	49.59 ± 10.23

SecondaryPROMIS Measures-positive Affect

Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported positive affect/well-being T-score range: 0-100 (higher score = better outcome)

Time frame:: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Reported as:: Mean · score on a scale

PROMIS Measures-positive Affect
score on a scale	Ketamine + Cognitive Training	Ketamine + Sham Training	Saline + Cognitive Training
PROMIS Measures-positive Affect	44.12 ± 7.72	44.02 ± 7.76	45.98 ± 7.60

SecondaryPROMIS Measures-sleep Disturbance

Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported sleep disturbance T-score range: 0-100 (higher score = worse outcome)

Time frame:: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Reported as:: Mean · score on a scale

PROMIS Measures-sleep Disturbance
score on a scale	Ketamine + Cognitive Training	Ketamine + Sham Training	Saline + Cognitive Training
PROMIS Measures-sleep Disturbance	53.06 ± 9.91	53.78 ± 8.63	51.41 ± 10.29

SecondaryPROMIS Measures-cognitive Function

Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported cognitive function T-score range: 0-100 (higher score = better outcome)

Time frame:: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Reported as:: Mean · score on a scale

PROMIS Measures-cognitive Function
score on a scale	Ketamine + Cognitive Training	Ketamine + Sham Training	Saline + Cognitive Training
PROMIS Measures-cognitive Function	43.61 ± 9.54	39.19 ± 8.07	44.87 ± 8.81

SecondaryPROMIS Measures-substance Use

Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported substance use Raw score range: 0-35 (higher score = worse outcome)

Time frame:: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Reported as:: Mean · score on a scale

PROMIS Measures-substance Use
score on a scale	Ketamine + Cognitive Training	Ketamine + Sham Training	Saline + Cognitive Training
PROMIS Measures-substance Use	3.00 ± 5.22	2.32 ± 5.09	3.03 ± 5.94

SecondaryPROMIS Measures-alcohol

Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported alcohol use T-score range: 0-100 (higher score = worse outcome)

Time frame:: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Reported as:: Mean · score on a scale

PROMIS Measures-alcohol
score on a scale	Ketamine + Cognitive Training	Ketamine + Sham Training	Saline + Cognitive Training
PROMIS Measures-alcohol	46.29 ± 8.56	47.82 ± 5.35	47.25 ± 7.04

SecondaryCognitive Triad Inventory

Negative perceptions of self, future, \& world (range=36-252; higher score = better outcome)

Time frame:: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Reported as:: Mean · score on a scale

Cognitive Triad Inventory
score on a scale	Ketamine + Cognitive Training	Ketamine + Sham Training	Saline + Cognitive Training
Cognitive Triad Inventory	133.89 ± 35.15	126.00 ± 39.02	138.97 ± 28.50

SecondaryColumbia-Suicide Severity Rating Scale

Suicidality and patient safety (most severe ideation score, range=0-5; higher score = worse outcome)

Time frame:: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Reported as:: Mean · score on a scale

Columbia-Suicide Severity Rating Scale
score on a scale	Ketamine + Cognitive Training	Ketamine + Sham Training	Saline + Cognitive Training
Columbia-Suicide Severity Rating Scale	0.70 ± 1.14	1.30 ± 1.24	1.10 ± 1.29

SecondaryWHO Disability Assessment Scale (SR)

Global functioning (range=0-48; higher score = worse outcome)

Time frame:: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Reported as:: Mean · score on a scale

WHO Disability Assessment Scale (SR)
score on a scale	Ketamine + Cognitive Training	Ketamine + Sham Training	Saline + Cognitive Training
WHO Disability Assessment Scale (SR)	10.58 ± 9.28	15.75 ± 10.87	12.64 ± 10.72

SecondaryCognitive Flexibility Scale

Self-reported cognitive flexibility (range=12-72; higher score = better outcome)

Time frame:: Trajectories from 24 hours through Month 12 post-infusion, Month 12 reported
Reported as:: Mean · score on a scale

Cognitive Flexibility Scale
score on a scale	Ketamine + Cognitive Training	Ketamine + Sham Training	Saline + Cognitive Training
Cognitive Flexibility Scale	52.64 ± 8.82	50.82 ± 10.81	51.20 ± 10.46

SecondaryNeuroplasticity-related Markers in Blood

ketamine metabolite (2R,6R)-HNK concentration levels (range=0-inf; higher score = greater concentration in blood)

Time frame:: 40min post-infusion
Reported as:: Mean · ng/mL

Neuroplasticity-related Markers in Blood
ng/mL	Ketamine + Cognitive Training	Ketamine + Sham Training
Neuroplasticity-related Markers in Blood	26.94 ± 11.59	27.35 ± 11.76

Adverse events

Collected over 4 hours. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Ketamine	0/103 (0%)	0/103 (0%)	102/103 (99%)
Saline	0/51 (0%)	0/51 (0%)	38/51 (74.5%)

Most frequent other events

Showing 10 of 27

Most frequent other events
Event	Ketamine	Saline
dissociative effectsPsychiatric disorders	100/103	11/51
dizzinessNervous system disorders	70/103	10/51
dry mouthGastrointestinal disorders	40/103	5/51
nauseaGastrointestinal disorders	31/103	7/51
restlessnessGeneral disorders	18/103	2/51
sweatingGeneral disorders	18/103	3/51
headacheNervous system disorders	17/103	4/51
decreased energyGeneral disorders	16/103	3/51
increased appetiteGastrointestinal disorders	12/103	1/51
palpitationsCardiac disorders	11/103	0/51

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Ketamine + Cognitive Training	Ketamine + Sham Training	Saline + Cognitive Training	Total
Mean	34.70 ± 10.10	34.60 ± 11.60	33.50 ± 9.90	34.26 ± 10.50

Sex: Female, Male
Sex: Female, Male(Participants)	Ketamine + Cognitive Training	Ketamine + Sham Training	Saline + Cognitive Training	Total
Female	32	32	33	97
Male	21	18	18	57

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Ketamine + Cognitive Training	Ketamine + Sham Training	Saline + Cognitive Training	Total
Hispanic or Latino	5	2	4	11
Not Hispanic or Latino	45	45	47	137
Unknown or Not Reported	3	3	0	6

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Ketamine + Cognitive Training	Ketamine + Sham Training	Saline + Cognitive Training	Total
American Indian or Alaska Native	0	0	0	0
Asian	4	2	3	9
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	3	2	2	7
White	44	40	41	125
More than one race	2	5	4	11
Unknown or Not Reported	0	1	1	2

Montgomery Asberg Depression Rating Scale
Montgomery Asberg Depression Rating Scale(units on a scale)	Ketamine + Cognitive Training	Ketamine + Sham Training	Saline + Cognitive Training	Total
Mean	32.28 ± 5.70	33.48 ± 4.90	32.61 ± 5.10	32.78 ± 5.30

Number of failed antidepressant trials
Number of failed antidepressant trials(trials)	Ketamine + Cognitive Training	Ketamine + Sham Training	Saline + Cognitive Training	Total
Mean	2.66 ± 1.59	2.60 ± 1.67	2.67 ± 2.46	2.64 ± 1.93

Study locations

1 site

Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania 15213, United States

References and documents

Publications

Price RB, Panny B, Degutis M, Griffo A. Repeated measurement of implicit self-associations in clinical depression: Psychometric, neural, and computational properties. J Abnorm Psychol. 2021 Feb;130(2):152-165. doi: 10.1037/abn0000651. Epub 2020 Dec 3. PubMed 33271040 ↗

Study documents

Protocol and statistical analysis plan · Aug 7, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — We will comply with all NIMH guidelines regarding data repository/sharing.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03237286
Lead sponsor: Rebecca Price
Collaborators: National Institute of Mental Health (NIMH)
Responsible party: Rebecca Price (Assistant Professor of Psychiatry, University of Pittsburgh) — Sponsor-investigator
First posted: Aug 2, 2017
Start date: Dec 1, 2017
Primary completion: Oct 18, 2022
Completion: Oct 18, 2022
Results posted: Nov 1, 2023
Last update: Mar 19, 2024

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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