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In this project, the investigators will administer a single infusion of IV ketamine to depressed patients and randomize the patients to receive either a) usual/typical infusion conditions or b) mindfulness training and exercises in conjunction with the infusion. Investigators will test whether the conjunction of ketamine + mindfulness enhances the reductions in depression following a single ketamine infusion.
NOTE: The study's target sample size was revised after beginning the study, based on a revised available budget.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Ketamine + Mindfulness Exercises | Experimental |
| |
| Intravenous Ketamine + Academic Exercises | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Ketamine | Drug | Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale | Clinician-rated depression (range: 0-60; higher scores = worse outcome) | 24hrs post-intervention |
| Montgomery-Asberg Depression Rating Scale | Clinician-rated depression (range: 0-60; higher scores = worse outcome) | 5 days post-intervention |
| Montgomery-Asberg Depression Rating Scale | Clinician-rated depression (range: 0-60; higher scores = worse outcome) | 12 days post-intervention |
| Montgomery-Asberg Depression Rating Scale | Clinician-rated depression (range: 0-60; higher scores = worse outcome) | 21 days post-intervention |
| Montgomery-Asberg Depression Rating Scale | Clinician-rated depression (range: 0-60; higher scores = worse outcome) | 30 days post-intervention |
| State Mindfulness Scale | Self-reported mindfulness (range 21-105; higher scores = more mindfulness) | 80min post-infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Hamilton Depression Rating Scale | Clinician-rated depression (range: 0-52; higher scores = worse outcome) | 24hrs post-intervention |
| Modified Hamilton Depression Rating Scale | Clinician-rated depression (range: 0-52; higher scores = worse outcome) |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Attention Response Task (SART) Omission Errors | performance-based measure of mindful attention | infusion +24 hours (1 day) |
| Sustained Attention Response Task (SART) Self-reported Task Focus | self-report rating of being on-task (range: 1-7; higher score=more on-task) |
Inclusion Criteria:
All participants will:
Exclusion Criteria:
All participants:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Price, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Psychiatric Institute and Clinic | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40964432 | Derived | Kheirkhah M, McDonald N, Aepfelbacher J, Rengasamy ML, Shivanekar S, Spotts C, Cooper I, Baumeister A, Bell E, Do-Nguyen K, Woody ML, Hossein S, Henter ID, Nugent AC, Hejazi NS, Jamalabadi H, Yavi M, Walter M, Zarate CA Jr, Price RB. Mindfulness, music, visual occlusion in ketamine therapy for depression: do they change outcomes? A qualitative and quantitative analysis of a randomized controlled trial. Front Psychiatry. 2025 Sep 2;16:1642025. doi: 10.3389/fpsyt.2025.1642025. eCollection 2025. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Intravenous Ketamine + Academic Exercises |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Montgomery-Asberg Depression Rating Scale | Clinician-rated depression (range: 0-60; higher scores = worse outcome) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | 24hrs post-intervention |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anxiety | Psychiatric disorders | Systematic Assessment |
Pilot study leading to small numbers of patients in each treatment arm. Descriptive statistics are reported without statistical analysis to directly compare groups, given the small number of patients within each group leading to low statistical power.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rebecca Price | University of Pittsburgh | 412-383-2150 | pricerb@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 9, 2022 | Jun 21, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Brief Mindfulness Exercises | Behavioral | 30min guided training in mindfulness meditation immediately prior to infusion |
|
| Academic Exercises | Behavioral | 30min of mental math and other academic cognitive puzzles completed silently/mentally |
|
| 5 days post-intervention |
| Modified Hamilton Depression Rating Scale | Clinician-rated depression (range: 0-52; higher scores = worse outcome) | 12 days post-intervention |
| Modified Hamilton Depression Rating Scale | Clinician-rated depression (range: 0-52; higher scores = worse outcome) | 21 days post-intervention |
| Modified Hamilton Depression Rating Scale | Clinician-rated depression (range: 0-52; higher scores = worse outcome) | 30 days post-intervention |
| Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | 24hrs post-intervention |
| Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | 5 days post-intervention |
| Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | 12 days post-intervention |
| Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | 21 days post-intervention |
| Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | 30 days post-intervention |
| Hood Mysticism Scale | clinician-administered to assess mystical experiences (range: -64 to +64; higher scores = greater mystical experience) | 40 minutes post-intervention |
| Mindful Attention Awareness Scale | self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness) | 24hrs post-intervention |
| Mindful Attention Awareness Scale | self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness) | 5 days post-intervention |
| Mindful Attention Awareness Scale | self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness) | 12 days post-intervention |
| Mindful Attention Awareness Scale | self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness) | 21 days post-intervention |
| Mindful Attention Awareness Scale | self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness) | 30 days post-intervention |
| Daily Spiritual Experience Scale | self-reported spiritual experiences (range: 1-6; higher scores=greater spiritual experience) | 5 days post-intervention |
| Daily Spiritual Experience Scale | self-reported spiritual experiences (range: 1-6; higher scores=greater spiritual experience) | 12 days post-intervention |
| Daily Spiritual Experience Scale | self-reported spiritual experiences (range: 1-6; higher scores=greater spiritual experience) | 21 days post-intervention |
| Daily Spiritual Experience Scale | self-reported spiritual experiences (range: 1-6; higher scores=greater spiritual experience) | 30 days post-intervention |
| infusion +24 hours (1 day) |
| Awe Experience Scale | self-report measure of awe-inspiring experiences (range: 30-210; higher score=greater awe) | infusion +80min |
| Dual Probe Video Task | attentional bias (proportion score) towards sad film clips (range: 0-1.0; higher score=greater attention bias towards sad films) | infusion +24 hours (1 day) |
| Pain Rating Via Quantitative Sensory Testing | Pain rating obtained from Quantitative Sensory Testing by mechanical temporal summation (range: 0-10; higher score=more pain) | 1-hour post-infusion |
| PROMIS Pain Intensity Score | PROMIS Pain Intensity Short Form scale T-score (range=0-100; higher score=worse pain) | 1-hour post-infusion |
| PROMIS Pain Interference Score | PROMIS Pain Interference Short Form scale T-score (range=0-100; higher score=worse pain) | 1-hour post-infusion |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Montgomery Asberg Depression Rating Scale | Clinician-rated depression (range: 0-60; higher scores = worse outcome) | Mean | Standard Deviation | units on a scale |
|
|
|
| Primary | Montgomery-Asberg Depression Rating Scale | Clinician-rated depression (range: 0-60; higher scores = worse outcome) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | 5 days post-intervention |
|
|
|
| Primary | Montgomery-Asberg Depression Rating Scale | Clinician-rated depression (range: 0-60; higher scores = worse outcome) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | 12 days post-intervention |
|
|
|
| Primary | Montgomery-Asberg Depression Rating Scale | Clinician-rated depression (range: 0-60; higher scores = worse outcome) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | 21 days post-intervention |
|
|
|
| Primary | Montgomery-Asberg Depression Rating Scale | Clinician-rated depression (range: 0-60; higher scores = worse outcome) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | 30 days post-intervention |
|
|
|
| Primary | State Mindfulness Scale | Self-reported mindfulness (range 21-105; higher scores = more mindfulness) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | 80min post-infusion |
|
|
|
| Secondary | Modified Hamilton Depression Rating Scale | Clinician-rated depression (range: 0-52; higher scores = worse outcome) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | 24hrs post-intervention |
|
|
|
| Secondary | Modified Hamilton Depression Rating Scale | Clinician-rated depression (range: 0-52; higher scores = worse outcome) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | 5 days post-intervention |
|
|
|
| Secondary | Modified Hamilton Depression Rating Scale | Clinician-rated depression (range: 0-52; higher scores = worse outcome) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | 12 days post-intervention |
|
|
|
| Secondary | Modified Hamilton Depression Rating Scale | Clinician-rated depression (range: 0-52; higher scores = worse outcome) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | 21 days post-intervention |
|
|
|
| Secondary | Modified Hamilton Depression Rating Scale | Clinician-rated depression (range: 0-52; higher scores = worse outcome) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | 30 days post-intervention |
|
|
|
| Secondary | Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | 24hrs post-intervention |
|
|
|
| Secondary | Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | 5 days post-intervention |
|
|
|
| Secondary | Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | 12 days post-intervention |
|
|
|
| Secondary | Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | 21 days post-intervention |
|
|
|
| Secondary | Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | 30 days post-intervention |
|
|
|
| Secondary | Hood Mysticism Scale | clinician-administered to assess mystical experiences (range: -64 to +64; higher scores = greater mystical experience) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | 40 minutes post-intervention |
|
|
|
| Secondary | Mindful Attention Awareness Scale | self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | 24hrs post-intervention |
|
|
|
| Secondary | Mindful Attention Awareness Scale | self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | 5 days post-intervention |
|
|
|
| Secondary | Mindful Attention Awareness Scale | self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | 12 days post-intervention |
|
|
|
| Secondary | Mindful Attention Awareness Scale | self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | 21 days post-intervention |
|
|
|
| Secondary | Mindful Attention Awareness Scale | self-reported trait mindfulness (range: 1-6; higher scores=greater mindfulness) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | 30 days post-intervention |
|
|
|
| Secondary | Daily Spiritual Experience Scale | self-reported spiritual experiences (range: 1-6; higher scores=greater spiritual experience) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | 5 days post-intervention |
|
|
|
| Secondary | Daily Spiritual Experience Scale | self-reported spiritual experiences (range: 1-6; higher scores=greater spiritual experience) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | 12 days post-intervention |
|
|
|
| Secondary | Daily Spiritual Experience Scale | self-reported spiritual experiences (range: 1-6; higher scores=greater spiritual experience) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | 21 days post-intervention |
|
|
|
| Secondary | Daily Spiritual Experience Scale | self-reported spiritual experiences (range: 1-6; higher scores=greater spiritual experience) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | 30 days post-intervention |
|
|
|
| Other Pre-specified | Sustained Attention Response Task (SART) Omission Errors | performance-based measure of mindful attention | Not Posted | infusion +24 hours (1 day) | Participants |
| Other Pre-specified | Sustained Attention Response Task (SART) Self-reported Task Focus | self-report rating of being on-task (range: 1-7; higher score=more on-task) | Not Posted | infusion +24 hours (1 day) | Participants |
| Other Pre-specified | Awe Experience Scale | self-report measure of awe-inspiring experiences (range: 30-210; higher score=greater awe) | Not Posted | infusion +80min | Participants |
| Other Pre-specified | Dual Probe Video Task | attentional bias (proportion score) towards sad film clips (range: 0-1.0; higher score=greater attention bias towards sad films) | Not Posted | infusion +24 hours (1 day) | Participants |
| Other Pre-specified | Pain Rating Via Quantitative Sensory Testing | Pain rating obtained from Quantitative Sensory Testing by mechanical temporal summation (range: 0-10; higher score=more pain) | Not Posted | 1-hour post-infusion | Participants |
| Other Pre-specified | PROMIS Pain Intensity Score | PROMIS Pain Intensity Short Form scale T-score (range=0-100; higher score=worse pain) | Not Posted | 1-hour post-infusion | Participants |
| Other Pre-specified | PROMIS Pain Interference Score | PROMIS Pain Interference Short Form scale T-score (range=0-100; higher score=worse pain) | Not Posted | 1-hour post-infusion | Participants |
| 0 |
| 22 |
| 0 |
| 22 |
| 22 |
| 22 |
| EG001 | 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 | 0 | 21 | 0 | 21 | 21 | 21 |
| decreased energy | General disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| difficulty sleeping: too little | Psychiatric disorders | Systematic Assessment |
|
| difficulty sleeping: too much | Psychiatric disorders | Systematic Assessment |
|
| dissociative symptoms | Psychiatric disorders | Systematic Assessment |
|
| dizziness | Nervous system disorders | Systematic Assessment |
|
| dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| elevated blood pressure | Vascular disorders | Systematic Assessment |
|
| emotional indifference | Psychiatric disorders | Systematic Assessment |
|
| headache | Nervous system disorders | Systematic Assessment |
|
| increased appetite | Gastrointestinal disorders | Systematic Assessment |
|
| increased weight | Metabolism and nutrition disorders | Systematic Assessment |
|
| loss of sexual desire | Reproductive system and breast disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| palpitations | Cardiac disorders | Systematic Assessment |
|
| restlessness | General disorders | Systematic Assessment |
|
| sweating | General disorders | Systematic Assessment |
|
| tremors | Nervous system disorders | Systematic Assessment |
|
| trouble achieving orgasm | Reproductive system and breast disorders | Systematic Assessment |
|
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