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Positron Emission Tomography Assessment of Ketamine Binding of the Serotonin Transporter

NCT ID: NCT02717052

Last Updated: 2018-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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

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Depression Ketamine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pilot I and Pilot III not randomised
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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(S)-ketamine

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

Group Type EXPERIMENTAL

(S)-ketamine (Main study)

Intervention Type 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)

Main Study: PET1

Intervention Type OTHER

\[11C\]DASB PET

Main Study: PET2

Intervention Type OTHER

\[11C\]DASB PET

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0.9% saline solution i.v. over 40 Minutes (ending 10 minutes before PET measurement)

Main Study: PET1

Intervention Type OTHER

\[11C\]DASB PET

Main Study: PET2

Intervention Type OTHER

\[11C\]DASB PET

(S)-ketamine (Pilot Study II, 5 subj.)

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

Group Type EXPERIMENTAL

(S)-ketamine (Pilot II)

Intervention Type 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.

PILOT Study II: PET1

Intervention Type OTHER

\[11C\]DASB PET

PILOT Study II: PET2

Intervention Type OTHER

\[11C\]DASB PET

(R,S)-ketamine (Pilot Study II, 5 subj.)

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

Group Type EXPERIMENTAL

(R,S)-ketamine (Pilot II)

Intervention Type 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.

PILOT Study II: PET1

Intervention Type OTHER

\[11C\]DASB PET

PILOT Study II: PET2

Intervention Type OTHER

\[11C\]DASB PET

(R,S)-ketamine (Pilot Study I, 12 subj.)

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

Group Type EXPERIMENTAL

PILOT Study I: PET1

Intervention Type OTHER

\[11C\]DASB PET

PILOT Study I: PET2

Intervention Type OTHER

\[11C\]DASB PET

(R,S)-ketamine (Pilot I)

Intervention Type 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)

(R,S)-ketamine (Pilot Study III, 12 subj.)

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

Group Type EXPERIMENTAL

(R,S)-ketamine (Pilot III)

Intervention Type DRUG

Ketamin-hameln (Ketaminhydrochlorid) 50mg/ml Ampullen; Hameln Pharma Plus GmbH; Sanova Pharma

Dosis: 0.80mg/kg bodyweight i.v. over 50

PILOT Study III: PET1

Intervention Type OTHER

\[11C\]DASB PET

PILOT Study III: PET2

Intervention Type OTHER

\[11C\]DASB PET

Interventions

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(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)

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Placebo

0.9% saline solution i.v. over 40 Minutes (ending 10 minutes before PET measurement)

Intervention Type DRUG

PILOT Study II: PET1

\[11C\]DASB PET

Intervention Type OTHER

PILOT Study II: PET2

\[11C\]DASB PET

Intervention Type OTHER

Main Study: PET1

\[11C\]DASB PET

Intervention Type OTHER

Main Study: PET2

\[11C\]DASB PET

Intervention Type OTHER

PILOT Study I: PET1

\[11C\]DASB PET

Intervention Type OTHER

PILOT Study I: PET2

\[11C\]DASB PET

Intervention Type OTHER

(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)

Intervention Type 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

Intervention Type DRUG

PILOT Study III: PET1

\[11C\]DASB PET

Intervention Type OTHER

PILOT Study III: PET2

\[11C\]DASB PET

Intervention Type OTHER

Other Intervention Names

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Esketaminhydrochlorid Esketaminhydrochlorid Ketaminhydrochlorid Ketaminhydrochlorid Ketaminhydrochlorid

Eligibility Criteria

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Inclusion Criteria

* 18-55 years
* somatic health
* severe unipolar depression according to DSM-IV (SCID) und HAM-D (for patients)
* capable of giving informed consent
* negative pregnancy test (females)

Exclusion Criteria

* severe somatic illness
* psychiatric disorder (for healthy controls)
* an axis I comorbidity other than MDD , other than anxiety symptoms (for patients)
* clinically relevant alterations in blood draw, ecg, and somatic testing
* substance dependency disorder
* intake of psychopharmacological medication in last 6 months
* first degree relative with Axis 1 disorder (for Pilot I study)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Rupert Lanzenberger

Assoc. Prof. PD Dr. Rupert Lanzenberger, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rupert Lanzenberger, Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry and Psychotherapy, Medical University of Vienna

Locations

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Department of Psychiatry and Psychotherapy, Medical University of Vienna

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Rupert Lanzenberger, Prof.

Role: CONTACT

[email protected]
014040035760

Facility Contacts

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Rupert Lanzenberger, A/Prof.

Role: primary

[email protected]
+43 40400 ext. 3825

References

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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.

Reference Type DERIVED
PMID: 29045739 (View on PubMed)

Other Identifiers

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2014-003280-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1643/2014

Identifier Type: -

Identifier Source: org_study_id

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