NCT02717052

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for phase_2 depression

Timeline
Completed

Started May 2016

Typical duration for phase_2 depression

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

3.7 years

First QC Date

March 11, 2016

Last Update Submit

October 12, 2018

Conditions

DepressionKetamine

Outcome Measures

Primary Outcomes (7)

  • 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

Secondary Outcomes (2)

  • 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

Study Arms (6)

(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

Drug: (S)-ketamine (Main study)Other: Main Study: PET1Other: Main Study: PET2

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

Drug: PlaceboOther: Main Study: PET1Other: 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

Drug: (S)-ketamine (Pilot II)Other: PILOT Study II: PET1Other: PILOT Study II: PET2

(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

Drug: (R,S)-ketamine (Pilot II)Other: PILOT Study II: PET1Other: PILOT Study II: PET2

(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

Other: PILOT Study I: PET1Other: PILOT Study I: PET2Drug: (R,S)-ketamine (Pilot I)

(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

Drug: (R,S)-ketamine (Pilot III)Other: PILOT Study III: PET1Other: PILOT Study III: PET2

Interventions

(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)

Also known as: Esketaminhydrochlorid
(S)-ketamine
(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.

Also known as: Esketaminhydrochlorid
(S)-ketamine (Pilot Study II, 5 subj.)
(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.

Also known as: Ketaminhydrochlorid
(R,S)-ketamine (Pilot Study II, 5 subj.)
PlaceboDRUG

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

Placebo
PILOT Study II: PET1OTHER

\[11C\]DASB PET

(R,S)-ketamine (Pilot Study II, 5 subj.)(S)-ketamine (Pilot Study II, 5 subj.)
PILOT Study II: PET2OTHER

\[11C\]DASB PET

(R,S)-ketamine (Pilot Study II, 5 subj.)(S)-ketamine (Pilot Study II, 5 subj.)
Main Study: PET1OTHER

\[11C\]DASB PET

(S)-ketaminePlacebo
Main Study: PET2OTHER

\[11C\]DASB PET

(S)-ketaminePlacebo
PILOT Study I: PET1OTHER

\[11C\]DASB PET

(R,S)-ketamine (Pilot Study I, 12 subj.)
PILOT Study I: PET2OTHER

\[11C\]DASB PET

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

Also known as: Ketaminhydrochlorid
(R,S)-ketamine (Pilot Study I, 12 subj.)
(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

Also known as: Ketaminhydrochlorid
(R,S)-ketamine (Pilot Study III, 12 subj.)
PILOT Study III: PET1OTHER

\[11C\]DASB PET

(R,S)-ketamine (Pilot Study III, 12 subj.)
PILOT Study III: PET2OTHER

\[11C\]DASB PET

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

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry and Psychotherapy, Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Related Publications (1)

  • 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.

    PMID: 29045739DERIVED

MeSH Terms

Conditions

Depression

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Rupert Lanzenberger, Prof.

    Department of Psychiatry and Psychotherapy, Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rupert Lanzenberger, Prof.

CONTACT

014040035760rupert.lanzenberger@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Pilot I and Pilot III not randomised
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. PD Dr. Rupert Lanzenberger, MD

Study Record Dates

First Submitted

March 11, 2016

First Posted

March 23, 2016

Study Start

May 1, 2016

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

October 15, 2018

Record last verified: 2018-10

Locations

AU(1)