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A randomized multicentric parallel arms study involving the use of ketamine for treatment-resistant depression will be held at three national health provider clinics in the Mexican population. The purpose of this study is to determine whether clinical response seen in previous studies is replicable in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine treated | Experimental |
| |
| Control, placebo treated | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | A single dose of 0.5mg/kg intravenous ketamine infusion will be administered over 40 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in baseline HDRS Score | The Hamilton Depression Rating Scale (HDRS) baseline score will be measured 20 minutes before ketamine infusion. After 40 minutes post-infusion, a second HDRS score will be obtained. | 20 minutes before and 40 minutes after ketamine infusion. |
| Daily change in HDRS post-ketamine infusion. | On a daily basis, from day 1-7 post-ketamine infusion, changes in HDRS score will be measured during the daily psychiatric evaluation. | 1,2,3,4,5,6 and 7. Days after ketamine infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline blood pressure (BP). | Baseline BP will be measured during the physical examination 20 minutes before ketamine infusion. | 20 minutes before ketamine infusion. |
| Changes from baseline in blood pressure (BP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul J Lamothe, M.D. | Contact | +52 (55) 11031750 | paul@lamothe.com | |
| David N Lopez-Garza, M.D. | Contact | + 52 (55) 11031750 | davidlopezgarza@prodigy.net.mx |
| Name | Affiliation | Role |
|---|---|---|
| Paul J Lamothe, M.D. | American British Cowdray Medical Center | Principal Investigator |
| David N Lopez-Garza, M.D. | American British Cowdray Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ABC Neurological Center | Recruiting | Mexico City | Mexico City | 05300 | Mexico |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D061218 | Depressive Disorder, Treatment-Resistant |
| D003863 | Depression |
| 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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| Placebo | Drug | Saline at 0.9% intravenous infusion will be administered over 40 minutes. |
|
BP will be monitored continuously for a 4-hour period. BP assessments will be taken every five minutes for the period mentioned. The assessment will start 20 minutes before ketamine administration and will finish 4hrs after starting.
| every 5 minutes in a 300 minutes period |
| Manuel Ruiz-Alvarez, M.D. |
| American British Cowdray Medical Center |
| Principal Investigator |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |