Clinical Trials Register

Summary
EudraCT Number:	2021-002604-12
Sponsor's Protocol Code Number:	PSY-NIL-0010
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-11-24
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Austria - BASG

A.2

EudraCT number

2021-002604-12

A.3

Full title of the trial

Unraveling the aesthetic mind in anhedonia, insights from pharmacological
imaging of the human brain: A single-blind, randomized, placebo-controlled
cross-over study

Einfluss von Ketamin auf ästhetische Prozesse und Relevanz für antidepressive
Effekte: eine einfachverblindete, randomisierte Placebo-kontrollierte cross-over
Studie

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

The effect of ketamine on aesthetics and role for antidepressant effects

Einfluss von Ketamin auf ästhetische Prozesse und Relevanz für antidepressive Effekte

A.3.2

Name or abbreviated title of the trial where available

Ketamine, aesthetics, antidepressant

Ketamin, Ästhetik, antidepressive Therapie

A.4.1

Sponsor's protocol code number

PSY-NIL-0010

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Medical University of Vienna
B.1.3.4	Country	Austria
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Medical University of Vienna, Interdisciplinary Cluster Project
B.4.2	Country	Austria
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Rupert Lanzenberger, Department of Psychiatry and Psychotherapy, Medical University of Vienna
B.5.2	Functional name of contact point	Sponsor
B.5.3	Address:
B.5.3.1	Street Address	Währinger Gürtel 18-20
B.5.3.2	Town/ city	Vienna
B.5.3.3	Post code	1090
B.5.3.4	Country	Austria
B.5.4	Telephone number	004314040035760
B.5.6	E-mail	rupert.lanzenberger@medunwien.ac.at

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Ketamin-hameln
D.2.1.1.2	Name of the Marketing Authorisation holder	Hameln Pharma Plus GmbH; Sanova Pharma
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Ketamin hameln
D.3.2	Product code	32265.00.00
D.3.4	Pharmaceutical form	Solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	KETAMINE
D.3.9.3	Other descriptive name	KETAMINE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB02830MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Depression

E.1.1.1

Medical condition in easily understood language

Depression

E.1.1.2

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To characterize the effects of ketamine on brain activation and connectivity

To characterize the effects of ketamine on hedonic experiences

Entschlüsselung des Einflusses von Ketamin auf Gehirn Aktivität und Konnektivität

Entschlüsselung des Einflusses von Ketamin auf hedonische Erfahrungen

E.2.2

Secondary objectives of the trial

Impact of Ketamine on reward processing and fMRI correlates in depression

Impact of Ketamine on sexual arousal and fMRI correlates in depression

Einfluss von Ketamin auf Belohnung und entsprechender fMRI Aktivität bei depressiven PatientInnen

Einfluss von Ketamin auf sexueller Erregung und entsprechender fMRI Aktivität bei depressiven PatientInnen

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

In a dose-finding pilot study, infusion of 0.25 and 0.5mg/kg bodyweight of ketamine will be administered intravenously to 5 healthy subjects each over the course of 40 min to test responsivity to the stimuli. Based on these findings, we will determine the dose for our main study.

In a BDNF (brain-derived neurotrophic factor) and immunology substudy, additional blood draws will be performed 1 day and 7 days after study drug and placebo administration (session 2 & 3). Plasma samples will be collected in plasma vacutainer tubes and processed within 2h of being collected to decrease variability. Serum samples will be left to clot for 30 minutes before centrifugation and further sample processing. Plasma and serum samples will be centrifuged at 1500 x g for 15 min and liquid portions pipetted and stored at -80°C until analysis of BDNF concentrations and immunological parameters. In all subjects of the main- and substudy, BDNF levels will be assessed before, 40 and 100 minutes after study drug administration as well as after fMRI scanning (approximately 280 minutes after study drug administration).

Im Rahmen einer Pilotstudie erhalten 5 ProbandInnen jeweils 0.25 and 0.5mg/kg Körpergewicht Ketamine über 40 Minuten. Probanden bekommen anschließend das Ästhetik Paradigma präsentiert. Es handelt sich um eine Dosisfindungsstudie.

In einer BDNF- (Brain-derived neurotrophic factor) und Immunologie-Substudie werden 1 Tag und 7 Tage nach der Verabreichung von Studienmedikament und Plazebo (Sitzung 2 und 3) zusätzliche Blutentnahmen durchgeführt. Die Plasmaproben werden in Plasma-Vakutainer-Röhrchen entnommen und innerhalb von 2 Stunden nach der Entnahme verarbeitet, um die Variabilität der Werte zu verringern. Die Serumproben werden vor der Zentrifugation und der weiteren Probenverarbeitung 30 Minuten lang gerinnen gelassen. Plasma- und Serumproben werden 15 Minuten lang bei 1500 x g zentrifugiert, die flüssigen Anteile abpipettiert und bis zur Analyse der BDNF-Konzentrationen und der immunologischen Parameter bei -80 °C gelagert. Bei allen ProbandInnen der Hauptstudie und Substudie werden die BDNF-Konzentrationen vor, 40 und 100 Minuten nach der Verabreichung des Studienmedikaments sowie nach dem fMRI-Scan (etwa 280 Minuten nach Verabreichung des Studienmedikaments) bestimmt.

E.3

Principal inclusion criteria

- General health based on medical history and physical examination
- Psychiatric health based on structured clinical interview for DSM--5 (SCID) for healthy controls
- Major depressive episode (first or recurrent) based on structured clinical interview for DSM- 5 and ICD-10 for patients
- Age 18 to 55 years
- Right-handedness (due to potential lateralization effects of left-handed subjects)
- Willingness and competence to sign the informed consent form.

-Internistische und neurologische Gesundheit
-Fehlen einer psychiatrischen Diagnose basierend auf dem Structured clinical interview for DSM-5 (SCID) (gesunde KontrollprobandInnen)
-Depressive Episode (erstmalig oder rezidivierend) basierend auf dem Structured clinical interview for DSM-5 (SCID) und ICD-10 (PatientInnen)
-18-55 Jahre
-RechtshänderInnen
-Einsichts- und Urteilsfähigkeit für Informed Consent

E.4

Principal exclusion criteria

-Current or history of neurological disease
-Current medical illness requiring treatment
-Psychiatric diagnosis for healthy individuals
-Psychiatric comorbidity with the exception of anxiety disorders for depressed individuals
-Pregnancy or current breastfeeding
-Current or former substance abuse
-Previous ketamine use in lifetime
-Any contraindication for MRI (e.g., MR incompatible implants, etc.) including dental implants causing signal artifacts
-Failure to comply with the study protocol or to follow the instruction of the investigating team.

-Gegenwärtige oder frühere neurologische Erkrankung
-gegenwärtige internistische Erkrankung
-Psychiatrische Diagnose bei gesunden KontrollprobandInnen
-Psychiatrische Komorbidität mit der Außnahme von Angststörungen bei PatientInnen
-Gegenwärtiger oder früherer Substanzmissbrauch.
-Schwangerschaft oder Stillen
-MRI Kontraindikationen
-früherer Ketamingebrauch
-Nicht-einhalten des Studienprotokolls

E.5 End points

E.5.1

Primary end point(s)

1. BOLD signal: cerebral activation, functional connectivity during aesthetic paradigm
2. resting state functional connectivity
3.fMRI activity
4. Chills, Pleasantness

1. BOLD signal: cerebral activation, functional connectivity during aesthetic paradigm
2. resting state functional connectivity
3. Chills, Pleasantness

E.5.1.1

Timepoint(s) of evaluation of this end point

1. Study Session 2, 3
2. Study Session 2, 3
3. Study Session 1,2, 3, 4

1. Untersuchungstag 2, 3
2. Untersuchungstag 2, 3
3. Untersuchungstag 1,2, 3, 4

E.5.2

Secondary end point(s)

1. BOLD signal: cerebral activation, functional connectivity during reward paradigm
2. BOLD signal: cerebral activation, functional connectivity during sexual arousal paradigm

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Study Session 2, 3
2. Study Session 2, 3

1. Untersuchungstag 2, 3
2. Untersuchungstag 2, 3

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Neuroscience

Neurowissenschaftlich

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

authorized for alternative indication

zugelassen für andere Indikation

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

Yes

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

Yes

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Last visit last subject

Letzte Visite letze TeilnehmerIn

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

expected normal treatment

erwartete normale Behandlung

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2022-01-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-02-09

P. End of Trial
P.	End of Trial Status	Ongoing

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials