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The purpose of this randomized, placebo-controlled study is to investigate pharmacodynamic differences between racemic ketamine and esketamine using functional fluorodeoxyglucose ([18F]FDG) positron emission tomography/magnetic resonance imaging (PET/MR)
Pilot study I:
A pilot study with healthy controls will be performed in order to investigate pharmacokinetic behavior and acute behavioral effects of intravenous ketamine infusion.
Pilot study II:
A pilot study including 15 healthy volunteers will be performed in order to optimize scanning procedures. The pilot study follows a randomized, placebo-controlled, double-blind, cross-over study design. After enrollment into the study all subjects will undergo two [18F]FDG PET/CT scans in the course of which they will receive either S-ketamine or placebo during the first scan and the respective other study medication during the second scan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esketamine ((S)-Ketamine) | Experimental | Single-blind placebo (saline) infusion will be performed during the first PET/MR scan in all subjects, i.e. both arms. In a cross-over study design, esketamine will be administered during the second scan and racemic ketamine during the third scan. |
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| Racemic ketamine ((R,S)-Ketamine) | Experimental | Single-blind placebo (saline) infusion will be performed during the first PET/MR scan in all subjects, i.e. both arms. In a cross-over study design, racemic ketamine will be administered during the second scan and esketamine during the third scan. |
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| Pilot study II: Esketamine ((S)-Ketamine) | Experimental | In a cross-over study design, esketamine will be administered during the first scan and placebo during the second scan. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine Hydrochloride | Drug | intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cerebral metabolic rate of glucose (CMRGlu) | Change in CMRGlu between each PET/MR scan | during PETMR/during 45 minutes of infusion |
| Change in cerebral blood flow (CBF) | Change in CMRGlu between each PET/MR scan | during PETMR/during 45 minutes of infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Positive and Negative Syndrome Scale | Minimum: 30, Maximum: 210; higher score indicates worse outcome | one hour after infusion to baseline |
| Change in Brief Psychiatric Rating Scale | Minimum: 18, Maximum: 126; higher score indicates worse outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rupert Lanzenberger, Prof. | Contact | 004314040035760 | rupert.lanzenberger@meduniwien.ac.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Recruiting | Vienna | 1090 | Austria |
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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 |
|---|---|
| D007649 | Ketamine |
| C000629870 | Esketamine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Esketamine | Drug | intravenous infusion |
|
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| Placebo | Drug | intravenous infusion |
|
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| Pilot study II: Esketamine | Drug | intravenous infusion |
|
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| Pilot study II: Placebo | Drug | intravenous infusion |
|
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| one hour after infusion to baseline |
| Change in Clinician Administered Dissociative States Scale | Minimum: 0, Maximum: 92; higher score indicates worse outcome | one hour after infusion to baseline |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |