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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003280-38 | EudraCT Number |
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The study at hand is the first to investigate ketamine's SERT binding in humans, by utilizing the highly selective SERT radioligand [11C]DASB and positron emission tomography.
Intravenous application of ketamine is currently dramatically gaining in significance as a rapid and highly effective antidepressant treatment option. Ketamine modulates various neurotransmitter systems, though the mechanisms responsible for its antidepressant effects remain unkownn. However, the serotonin transporter (SERT) presents a target of high interest due to the SERT's fundamental role in depression's pathophysiology as well as in antidepressant response. The study at hand is the first to investigate ketamine's SERT binding in humans, by utilizing the highly selective SERT radioligand [11C]DASB and positron emission tomography. Further, investigation of severely depressed patients provides the unique opportunity to establish the relationship between ketamine's SERT binding and its antidepressant efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (S)-ketamine | Experimental | Ketanest® S (Esketaminhydrochlorid) 5mg/ml and 25mg/ml ampoules; Actavis Italy S.P.A./Pfizer Corporation Austria GmbH Dosis: 0.25mg/kg bodyweight i.v. over 40 Minutes (ending 10 minutes before PET measurement) all patients and 10 HC (randomized, double blind) Interventions: Drug: (S)-ketamine (Main study) Other: Main study: PET1 Other: Main study: PET2 |
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| Placebo | Placebo Comparator | 0.9% saline solution i.v. over 40 Minutes (ending 10 minutes before PET measurement) 10 HC (randomized, double blind) Interventions: Drug: Placebo Other: Main study: PET1 Other: Main study: PET2 |
|
| (S)-ketamine (Pilot Study II, 5 subj.) | Experimental | Ketanest® S (Esketaminhydrochlorid) 5mg/ml and 25mg/ml ampoules; Actavis Italy S.P.A./Pfizer Corporation Austria GmbH Dosis: 0.10mg/kg bodyweight bolus applied over 5 minutes (starting 15 minutes before PET measurement) and continuous infusion of 0.30mg/kg bodyweight applied over the course of 130 minutes. Pilot-study II is cross-over design! Interventions: Drug: (S)-ketamine (Pilot II) Other: PILOT Study II: PET1 Other: PILOT Study II: PET2 |
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| (R,S)-ketamine (Pilot Study II, 5 subj.) | Experimental | Ketamin-hameln (Ketaminhydrochlorid) 50mg/ml Ampullen; Hameln Pharma Plus GmbH; Sanova Pharma Dosis: 0.20mg/kg bodyweight bolus applied over 5 minutes (starting 15 minutes before PET measurement) and continuous infusion of 0.60mg/kg bodyweight applied over the course of 130 minutes. Pilot-study II is cross-over design! Interventions: Drug: (R,S)-ketamine (Pilot II) Other: PILOT Study II: PET1 Other: PILOT Study II: PET2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (S)-ketamine (Main study) | Drug | Ketanest® S (Esketaminhydrochlorid) 5mg/ml and 25mg/ml ampoules; Actavis Italy S.P.A./Pfizer Corporation Austria GmbH Dosis: 0.25mg/kg bodyweight i.v. over 40 Minutes (ending 10 minutes before PET measurement) |
| Measure | Description | Time Frame |
|---|---|---|
| Pilot Study II: (S)-ketamine SERT occupancy assessed with DASB binding potential (BP) | Occupancy assessed using kinetic modeling | during PET/during 135 minutes of infusion |
| Pilot Study II: (R,S)-ketamine SERT occupancy assessed with DASB binding potential (BP) | Occupancy assessed using kinetic modeling | during PET/during 135 minutes of infusion |
| Main Study: (S)-ketamine SERT occupancy assessed with DASB binding potential (BP) | Occupancy (%)=(1-BPND PET 2 (treatment) / BPND PET 1 (baseline)) x100 | during PET/starting 10 minutes afer 40 minutes of infusion |
| Pilot Study I: (R,S)-ketamine SERT occupancy assessed with DASB binding potential (BP) | Occupancy (%)=(1-BPND PET 2 (treatment) / BPND PET 1 (baseline)) x100 | during PET/starting 10 minutes afer 40 minutes of infusion |
| Pilot Study III: (R,S)-ketamine SERT occupancy assessed with DASB binding potential (BP) | Occupancy (%)=(1-BPND PET 2 (treatment) / BPND PET 1 (baseline)) x100 | during PET |
| Pilot Study III: resting state MRI | changes to rsFC and rsfMRI after (R,S)-ketamine | after PET 2 |
| Pilot Study III: MRS | changes to Glutamate, GABA, and metabolites after (R,S)-ketami | after PET 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hamilton Depression Rating Scale Points | 2 hours after infusion to baseline | |
| Change in Hamilton Depression Rating Scale Points | 1 day after infusion to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rupert Lanzenberger, Prof. | Contact | 014040035760 | rupert.lanzenberger@meduniwien.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Rupert Lanzenberger, Prof. | Department of Psychiatry and Psychotherapy, Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry and Psychotherapy, Medical University of Vienna | Recruiting | Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29045739 | Derived | Spies M, James GM, Berroteran-Infante N, Ibeschitz H, Kranz GS, Unterholzner J, Godbersen M, Gryglewski G, Hienert M, Jungwirth J, Pichler V, Reiter B, Silberbauer L, Winkler D, Mitterhauser M, Stimpfl T, Hacker M, Kasper S, Lanzenberger R. Assessment of Ketamine Binding of the Serotonin Transporter in Humans with Positron Emission Tomography. Int J Neuropsychopharmacol. 2018 Feb 1;21(2):145-153. doi: 10.1093/ijnp/pyx085. |
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Pilot I and Pilot III not randomised
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| (R,S)-ketamine (Pilot Study I, 12 subj.) | Experimental | Ketamin-hameln (Ketaminhydrochlorid) 50mg/ml Ampullen; Hameln Pharma Plus GmbH; Sanova Pharma Dosis: 0.50mg/kg bodyweight i.v. over 40 Minutes (ending 5 minutes before PET measurement) Interventions: Drug: (R,S)-ketamine (Pilot I) Other: PILOT Study I: PET1 Other: PILOT Study I: PET2 |
|
| (R,S)-ketamine (Pilot Study III, 12 subj.) | Experimental | Ketamin-hameln (Ketaminhydrochlorid) 50mg/ml Ampullen; Hameln Pharma Plus GmbH; Sanova Pharma Dosis: 0.80mg/kg bodyweight i.v. over 50 Minutes Interventions: Drug: (R,S)-ketamine (Pilot III) Other: PILOT Study III: PET1 Other: PILOT Study III: PET2 |
|
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| (S)-ketamine (Pilot II) | Drug | Ketanest® S (Esketaminhydrochlorid) 5mg/ml and 25mg/ml ampoules; Actavis Italy S.P.A./Pfizer Corporation Austria GmbH Dosis: 0.10mg/kg bodyweight i.v. bolus applied over 5 minutes (starting 15 minutes before PET measurement) and continuous infusion of 0.30mg/kg bodyweight i.v. applied over the course of 130 minutes. |
|
|
| (R,S)-ketamine (Pilot II) | Drug | Ketamin-hameln (Ketaminhydrochlorid) 50mg/ml Ampullen; Hameln Pharma Plus GmbH; Sanova Pharma Dosis: 0.20mg/kg bodyweight i.v. bolus applied over 5 minutes (starting 15 minutes before PET measurement) and continuous infusion of 0.60mg/kg bodyweight applied i.v. over the course of 130 minutes. |
|
|
| Placebo | Drug | 0.9% saline solution i.v. over 40 Minutes (ending 10 minutes before PET measurement) |
|
| PILOT Study II: PET1 | Other | [11C]DASB PET |
|
| PILOT Study II: PET2 | Other | [11C]DASB PET |
|
| Main Study: PET1 | Other | [11C]DASB PET |
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| Main Study: PET2 | Other | [11C]DASB PET |
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| PILOT Study I: PET1 | Other | [11C]DASB PET |
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| PILOT Study I: PET2 | Other | [11C]DASB PET |
|
| (R,S)-ketamine (Pilot I) | Drug | Ketamin-hameln (Ketaminhydrochlorid) 50mg/ml Ampullen; Hameln Pharma Plus GmbH; Sanova Pharma Dosis: 0.50mg/kg bodyweight i.v. over 40 Minutes (ending 10 minutes before PET measurement) |
|
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| (R,S)-ketamine (Pilot III) | Drug | Ketamin-hameln (Ketaminhydrochlorid) 50mg/ml Ampullen; Hameln Pharma Plus GmbH; Sanova Pharma Dosis: 0.80mg/kg bodyweight i.v. over 50 |
|
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| PILOT Study III: PET1 | Other | [11C]DASB PET |
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| PILOT Study III: PET2 | Other | [11C]DASB PET |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| 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 |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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