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The current study wishes to contribute to the applicability of the use of ketamine in a clinical setting by focusing on the efficacy of intra-nasal administration compared with the IV route.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active IV | Active Comparator | Will receive IV Ketamine, along with IN placebo. |
|
| Active IN | Active Comparator | Will receive IN Ketamine, along with IV placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Saline 0.9%, Administration of 0.2mg/kg (IV Push) or 50mg (IN, 5 doses, alternating nostrils) |
|
| Measure | Description | Time Frame |
|---|---|---|
| MADRS (Montgomery-Ã…sberg Depression Rating Scale) score improvement from baseline | 15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of subjects achieving remission | 15 weeks | |
| Ratio of subjects achieving Response | 15 weeks | |
| Durability of anti-depressant effect according to MADRS Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aviv Segev, MD | Shalvata MHC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shalvata MHC | Hod HaSharon | POB 94 | Israel |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Ketamine (1st phase) | Drug | Administration of 0.2mg/kg (IV Push) or 50mg (IN, 5 doses, alternating nostrils) |
|
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| Ketamine (2st phase) | Drug | Patients failing to achieve response (<50% MADRS score) in the parallal phase, will be offered additional 4 session (twice a week, 2 weeks) of 0.5 mg/kg ketamine over 40 minutes. |
|
|
The rate of effect decline, as measured by MADRS Questionnaire |
| 15 weeks |
| Tolerability of Route, based on side effects questionnaire | Adverse side effects reported by subjects, as reported in side effects questionnaire | 3 weeks |
| D017670 |
| Sodium Compounds |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |