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In this project, we will A) track the functioning of a collection of potential neurobiological targets for depression over time, B) examine how fluctuations in the functioning of those targets relates to real-world functioning, and C) in a subset of the sample, determine how the functioning in those targets is altered by a single dose of ketamine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Ketamine | Experimental | Open-label ketamine infusion |
|
| 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 |
|---|---|---|
| fMRI Intrinsic Connectivity: Default Mode Network | functional connectivity normalized correlation values within default mode network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity) | 24hrs post-intervention |
| fMRI Intrinsic Connectivity: Frontoparietal Control Network | functional connectivity normalized correlation values within frontoparietal control network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity) | 24hrs post-intervention |
| fMRI Intrinsic Connectivity: Limbic Network | functional connectivity normalized correlation values within limbic network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity) | 24hrs post-intervention |
| fMRI Intrinsic Connectivity: Salience Network | functional connectivity normalized correlation values within salience ventral attentional network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity) | 24hrs post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| fMRI Intrinsic Connectivity: Dorsal Attention Network | functional connectivity normalized correlation values within dorsal attention network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity) | 24hrs post-intervention |
| fMRI Intrinsic Connectivity: Somatosensory Motor Network |
| Measure | Description | Time Frame |
|---|---|---|
| Dual Probe Video Task | attentional bias (proportion score) towards sad film clips (range: 0 to +1.0; higher score=greater attention bias towards sad films) | infusion +24 hours (1 day) |
| Pain Rating Via Quantitative Sensory Testing |
Inclusion Criteria:
All participants will:
Exclusion Criteria:
All participants:
Ketamine phase subsample additional exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Psychiatric Institute and Clinic | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intravenous Ketamine | Open-label ketamine infusion Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous Ketamine | Open-label ketamine infusion Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min) |
| 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 | fMRI Intrinsic Connectivity: Default Mode Network | functional connectivity normalized correlation values within default mode network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity) | All participants who received a ketamine infusion | Posted | Mean | Standard Deviation | units 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 | Open-label ketamine infusion Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| decreased energy | General disorders | Systematic Assessment |
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| 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 3, 2021 | Jul 4, 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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functional connectivity normalized correlation values within somatosensory motor network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity) |
| 24hrs post-intervention |
| fMRI Intrinsic Connectivity: Visual Network | functional connectivity normalized correlation values within visual network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity) | 24hrs post-intervention |
| 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 |
| Hamilton Depression Rating Scale (Modified Score) | Clinician-rated depression (range: 0-52; higher scores = worse outcome) | 24hrs post-intervention |
| Hamilton Depression Rating Scale (Modified Score) | Clinician-rated depression (range: 0-52; higher scores = worse outcome) | 5 days post-intervention |
| Hamilton Depression Rating Scale (Modified Score) | Clinician-rated depression (range: 0-52; higher scores = worse outcome) | 12 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 |
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 |
| 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 | score on a scale |
|
|
|
| Primary | fMRI Intrinsic Connectivity: Frontoparietal Control Network | functional connectivity normalized correlation values within frontoparietal control network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity) | All participants who received a ketamine infusion | Posted | Mean | Standard Deviation | units on a scale | 24hrs post-intervention |
|
|
|
| Primary | fMRI Intrinsic Connectivity: Limbic Network | functional connectivity normalized correlation values within limbic network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity) | All participants who received a ketamine infusion | Posted | Mean | Standard Deviation | units on a scale | 24hrs post-intervention |
|
|
|
| Primary | fMRI Intrinsic Connectivity: Salience Network | functional connectivity normalized correlation values within salience ventral attentional network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity) | All participants who received a ketamine infusion | Posted | Mean | Standard Deviation | units on a scale | 24hrs post-intervention |
|
|
|
| Secondary | fMRI Intrinsic Connectivity: Dorsal Attention Network | functional connectivity normalized correlation values within dorsal attention network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity) | All participants who received a ketamine infusion | Posted | Mean | Standard Deviation | units on a scale | 24hrs post-intervention |
|
|
|
| Secondary | fMRI Intrinsic Connectivity: Somatosensory Motor Network | functional connectivity normalized correlation values within somatosensory motor network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity) | All participants who received a ketamine infusion | Posted | Mean | Standard Deviation | units on a scale | 24hrs post-intervention |
|
|
|
| Secondary | fMRI Intrinsic Connectivity: Visual Network | functional connectivity normalized correlation values within visual network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity) | All participants who received a ketamine infusion | Posted | Mean | Standard Deviation | units on a scale | 24hrs post-intervention |
|
|
|
| Secondary | 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 |
|
|
|
| Secondary | 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 |
|
|
|
| Secondary | 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 |
|
|
|
| Secondary | Hamilton Depression Rating Scale (Modified Score) | 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 | Hamilton Depression Rating Scale (Modified Score) | 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 | Hamilton Depression Rating Scale (Modified Score) | 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 | 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 |
|
|
|
| Other Pre-specified | Dual Probe Video Task | attentional bias (proportion score) towards sad film clips (range: 0 to +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 |
| 15 |
| 0 |
| 15 |
| 14 |
| 15 |
| difficulty sleeping: too little | Psychiatric disorders | Systematic Assessment |
|
| dissociative symptoms | Psychiatric disorders | Systematic Assessment |
|
| dizziness | Nervous system disorders | Systematic Assessment |
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| dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| emotional indifference | Psychiatric disorders | Systematic Assessment |
|
| headache | Nervous system disorders | Systematic Assessment |
|
| increased appetite | Gastrointestinal disorders | Systematic Assessment |
|
| loss of sexual desire | Reproductive system and breast disorders | Systematic Assessment |
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| nausea | Gastrointestinal disorders | Systematic Assessment |
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| restlessness | General disorders | Systematic Assessment |
|
| sweating | General disorders | Systematic Assessment |
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| tremors | Nervous system disorders | Systematic Assessment |
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| trouble achieving orgasm | Reproductive system and breast disorders | Systematic Assessment |
|
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