NCT02717052

Positron Emission Tomography Assessment of Ketamine Binding of the Serotonin Transporter

Positron Emission Tomography Assessment of Ketamine Binding of the Serotonin Transporter and Its Relevance for Rapid Antidepressant Response

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Depression
• Ketamine

Interventions

Type	Name	Description
DRUG	(S)-ketamine (Main study)	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)
DRUG	(S)-ketamine (Pilot II)	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.
DRUG	(R,S)-ketamine (Pilot II)	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.
DRUG	Placebo	0.9% saline solution i.v. over 40 Minutes (ending 10 minutes before PET measurement)
OTHER	PILOT Study II: PET1	\[11C\]DASB PET
OTHER	PILOT Study II: PET2	\[11C\]DASB PET
OTHER	Main Study: PET1	\[11C\]DASB PET
OTHER	Main Study: PET2	\[11C\]DASB PET
OTHER	PILOT Study I: PET1	\[11C\]DASB PET
OTHER	PILOT Study I: PET2	\[11C\]DASB PET
DRUG	(R,S)-ketamine (Pilot I)	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)
DRUG	(R,S)-ketamine (Pilot III)	Ketamin-hameln (Ketaminhydrochlorid) 50mg/ml Ampullen; Hameln Pharma Plus GmbH; Sanova Pharma Dosis: 0.80mg/kg bodyweight i.v. over 50
OTHER	PILOT Study III: PET1	\[11C\]DASB PET
OTHER	PILOT Study III: PET2	\[11C\]DASB PET

Timeline

• Start date: 2016-05-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2016-03-23
• Last updated: 2018-10-15

Locations

1 site across 1 country: Austria