Positron Emission Tomography Assessment of Ketamine Binding of the Serotonin Transporter

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.

Conditions

• Depression
• Ketamine

Interventions

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

Sponsors & Collaborators

• Medical University of Vienna

  lead OTHER

Principal Investigators

• Rupert Lanzenberger, Prof. · Department of Psychiatry and Psychotherapy, Medical University of Vienna

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-05-31

Primary Completion

2019-12-31

Completion

2019-12-31

Countries

• Austria

Study Locations