Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Positron Emission Tomography assessment of Ketamine Binding of the Serotonin Transporter and its Relevance for Rapid Antidepressant Response

    Summary
    EudraCT number
    		 2014-003280-38
    Trial protocol
    		 AT  
    Global end of trial date
    02 Sep 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Dec 2023
    First version publication date
    13 Dec 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    PSY-NIL-0006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02717052
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Währingergürtel 18-20, Vienna, Austria, 1090
    Public contact
    Univ. Prof. Rupert Lanzenberger, Department of Psychiatry and Psychotherapy, rupert.lanzenberger@meduniwien.ac.at
    Scientific contact
    Univ. Prof. Rupert Lanzenberger, Department of Psychiatry and Psychotherapy, rupert.lanzeberger@meduniwien.ac.at
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Sep 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Sep 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Sep 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The study at hand is the first to investigate ketamine’s serotonin transporter (SERT) binding in humans, by utilizing the highly selective SERT radioligand [11C]DASB and positron emission tomography (PET). Further, investigation of severely depressed patients provides the unique opportunity to establish the relationship between ketamine’s SERT binding and its antidepressant efficacy. We aim to investigate 1. Does Esketamine Hydrochloride bind the SERT?* 2. Does binding of Esketamine Hydrochloride to the SERT predict antidepressant response?* As part of amendments following changes were made: Pilot studies: PI. Does 0.50 mg/kg BW ketamine (racemic ketamine, ketamine Hameln) bind to the SERT (measured with PET) PIII: Does 0.80 mg/kg BW ketamine (racemic ketamine, ketamine Hameln) bind to the SERT (measured with PET)** Sub-study: Sub: Does 0.80 mg/kg BW ketamine affect glutamate and GABA levels (measured with MRS) *not assessed b/c pilot results were neg. **not analysed
    Protection of trial subjects
    Participants were observed by medical staff during the experimental procedures Side effects were evaluated
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Jun 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 77
    Worldwide total number of subjects
    77
    EEA total number of subjects
    77
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    77
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Recruitment was performed via local advertisement

    Pre-assignment
    Screening details
    		 Inclusion and exclusion criteria were assessed prior to inclusion.

    Period 1
    Period 1 title
    Pilot study I, III, MRS substudy (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Pilot I
    Arm description
    		 0.5mg/kg bodyweight racemic ketamine (ketamine Hameln) diluted in 0.9% saline solution and applied intravenously with infusion pump
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ketaminhydrochlorid (Ketamin hameln, 50mg/ml Ampullen; Hameln Pharma Plus GmbH; Sanova Pharma)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.5mg/kg bodyweight diluted in 0.9% saline solution, i.v., with infusion pump, over 40 min.

    Arm title
    		 Pilot III and MRS substudy
    Arm description
    		 0.8mg/kg bodyweight racemic ketamine (ketamine Hameln) diluted in 0.9% saline solution and applied intravenously with infusion pump
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ketaminhydrochlorid (Ketamin hameln, 50mg/ml Ampullen; Hameln Pharma Plus GmbH; Sanova Pharma)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.8mg/kg bodyweight diluted in 0.9% saline solution, i.v., with infusion pump, over 40 min.

    Number of subjects in period 1
    		Pilot I Pilot III and MRS substudy
    Started
    26
    51
    Completed
    12
    28
    Not completed
    14
    23
         Protocol deviation
    14
    23

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Pilot study I, III, MRS substudy
    Reporting group description
    		 -

    Reporting group values
    		 Pilot study I, III, MRS substudy Total
    Number of subjects
    		 77 77
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 25.86 ± 4.51 -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 77 77

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Pilot I
    Reporting group description
    		 0.5mg/kg bodyweight racemic ketamine (ketamine Hameln) diluted in 0.9% saline solution and applied intravenously with infusion pump

    Reporting group title
    Pilot III and MRS substudy
    Reporting group description
    		 0.8mg/kg bodyweight racemic ketamine (ketamine Hameln) diluted in 0.9% saline solution and applied intravenously with infusion pump

    Subject analysis set title
    Pilot I
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Pilot I

    Subject analysis set title
    MRS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Pilot III with MRS data and MRS substudy

    Subject analysis set title
    Pilot I baseline
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Baseline PET

    Subject analysis set title
    MRS baseline
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    baseline MRS

    Primary: SERT occupancy

    		 Close Top of page
    End point title
    		 SERT occupancy [1]
    End point description
    End point type
    Primary
    End point timeframe
    PET 1 to PET 2
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This analysis is only performed for the Pilot I study
    End point values
    		 Pilot I Pilot I Pilot I baseline
    Number of subjects analysed
    12
    12
    12
    Units: Percent
    12
    12
    12
    Statistical analysis title
    		 Occupancy
    Statistical analysis description
    (1-(BPND PET2/BPND PET1))*100
    Comparison groups
    Pilot I baseline v Pilot I
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.5
    Method
    		 descriptive
    Confidence interval

    Other pre-specified: GABA+/tCr

    		 Close Top of page
    End point title
    		 GABA+/tCr [2]
    End point description
    End point type
    Other pre-specified
    End point timeframe
    MRI1 to MRI2
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This analysis is only performed for the MRS substudy and some pilot III subjects im whom MRS is available
    End point values
    		 Pilot III and MRS substudy MRS MRS baseline
    Number of subjects analysed
    25
    25
    25
    Units: arbitrary
    25
    25
    25
    Statistical analysis title
    		 repeated measures analyses of variance (rmANOVA)
    Statistical analysis description
    Repeated measures analyses of variance (rmANOVA); metabolite (GABA+/tCr, Glx/tCr or GABA+/Glx) dependent variable, measurement (MRI1, MRI2) and ROI (thalamus, hippocampus, insula, putamen, rACC, cACC, PCC) within-subject factors, including interaction (measurement by region) and main effects (measurement, region) were tested.
    Comparison groups
    MRS v MRS baseline
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.5
    Method
    		 ANOVA
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Entirety of study participation
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    2016
    Reporting groups
    Reporting group title
    Pilot I
    Reporting group description
    		 -

    Reporting group title
    Pilot III and MRS
    Reporting group description
    		 -

    Serious adverse events
    		 Pilot I Pilot III and MRS
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Pilot I Pilot III and MRS
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 12 (100.00%)
    30 / 30 (100.00%)
    Cardiac disorders
    Hypertension
         subjects affected / exposed
    2 / 12 (16.67%)
    18 / 30 (60.00%)
         occurrences all number
    2
    18
    Tachycardia
         subjects affected / exposed
    3 / 12 (25.00%)
    11 / 30 (36.67%)
         occurrences all number
    3
    11
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 12 (0.00%)
    3 / 30 (10.00%)
         occurrences all number
    0
    3
    Psychiatric disorders
    Dissociation
         subjects affected / exposed
    12 / 12 (100.00%)
    30 / 30 (100.00%)
         occurrences all number
    12
    30

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 May 2016
    Added Ketanest S 25mg/ml Ampoules as study drug
    08 Jun 2016
    Added Pilot Study I and II
    31 May 2017
    Added Pilot Study III
    13 Sep 2018
    Added MRS substudy

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon Apr 29 13:17:28 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA