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| Name | Class |
|---|---|
| Columbia University | OTHER |
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We will be developing an EEG-based biomarker for the effects of ketamine infusion in patients with Depression. We will be analyzing the effects of ketamine infusion on Depression symptoms and EEG signals.
This trial is a biomarker development study. We will be examining the effects of various doses of ketamine infusion on depressive symptoms and EEG signals in patients with unipolar depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low level ketamine | Experimental | 0.25 mg/kg ketamine infusion |
|
| Medium level ketamine | Experimental | 0.5 mg/kg ketamine infusion |
|
| High level ketamine | Experimental | 0.75 mg/kg ketamine infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine (0.25 mg/kg) | Drug | Low level ketamine infusion therapy. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Rating Scale (HDRS) 22 | Twenty-two question Depression rating scale (excluding the two questions on weight loss and diurnal variation) | Baseline, Hour 1, Hour 4, Hour 24, and Hour 72 |
| Measure | Description | Time Frame |
|---|---|---|
| The Columbia Suicidality Severity Rating Scale (C-SSRS) | A semi-structured, investigator-rated interview assessing both suicidal behavior and suicidal ideation. | Baseline, Hour 1, Hour 4, Hour 24, and Hour 72 |
| The Clinician Administered Dissociative States Scale (CADSS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yishai Valter, MS | Contact | 8889908327 | trials@soterixmedical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
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| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| D003863 | Depression |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Ketamine (0.5 mg/kg) |
| Drug |
Medium level ketamine infusion therapy. |
|
| Ketamine (0.75 mg/kg) | Drug | High level ketamine infusion therapy. |
|
A scale that rates dissociative symptoms with a 27-item scale, rated 0-4, 19 subjective, and 8 observer items |
| Baseline, and Hour 1 |
| Montgomery-Asberg Depression Rating Scale (MADRS) | A ten-item diagnostic used for the assessment of depression severity | Baseline and Hour 24 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |