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In this study we will assess the effect of Ketamine infusion on depressive symptoms and in particular its effect on Suicidal behavior, ideation and thoughts in patients with treatment- resistant MDD.
A Twice repetition of IV infusion of 0.5 mg/kg of ketamine produces an antidepressant response in individuals with treatment-resistant MDD
The work aims to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine group | Active Comparator | This group had ketamine |
|
| Placebo group | No Intervention | This group had not take ketamine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | Ketamine is a high-affinity, noncompetitive N-methyl-D- aspartate (NMDA) glutamate receptor antagonist it has been used in anesthesiology for more than 50 years the time course of antidepressant response to ketamine is characterized by an initial reduction in depressive symptoms within 2 h |
| Measure | Description | Time Frame |
|---|---|---|
| Role of Ketamine as Antidepressant | the onset of action and degree of improvement and the duration of antidepressant effect of ketamine in a sample of patients with treatment -resistant major depressive disorder. | 1 year |
| Effect of Ketamine on Suicidality | finding out whether the onset of Ketamine antidepressant effect is associated with an improvement of suicidality in those patients | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut university | Asyut | Egypt |
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| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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The Sequentially Numbered, Opaque, Sealed Envelope technique (Schulz and Grimes, 2002) was employed: the randomization group was listed on paper and preserved in an opaque sealed envelope with a serial number. When a patient agreed to participate, the pharmacy (care provider) opened the sealed envelope and assigned the patient to the appropriate treatment group on the morning of their first infusion.
|
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |