Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
453
Countries
5
Sites
11
Major depressive disorder
The primary objective is to compare the treatment response (baseline; visit 2 vs. end of treatment; visit 4), expressed as symptoms severity at six weeks and changes in symptom severity from baseline as measured by the Montgomery Åsberg Depression Rating Scale (MADRS) under an early-intensified pharmacological treatmen…
Key facts
- Sponsor
- Universitair Medisch Centrum Utrecht
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 29 Aug 2024 → ongoing
- Decision date (initial)
- 2024-01-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- European Commission
External identifiers
- EU CT number
- 2023-506617-21-00
- ClinicalTrials.gov
- NCT05973851
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The primary objective is to compare the treatment response (baseline; visit 2 vs. end of treatment; visit 4), expressed as symptoms severity at six weeks and changes in symptom severity from baseline as measured by the Montgomery Åsberg Depression Rating Scale (MADRS) under an early-intensified pharmacological treatment to that under treatment as usual.
Secondary objectives 9
- To compare changes in severity and improvement in global functioning assessed by the Clinical Global Impression Scale (CGI) between the two treatment arms.
- To compare changes in the levels of depression and anxiety between treatment arms.
- To compare changes in quality of life and functioning measures between treatment arms.
- To compare changes in cognitive performance between treatment arms.
- To compare the proportion of participants (EIPT vs. TAU) that is in symptomatic remission at visit 4.
- To compare presence of adverse events (related and unrelated to treatment) between treatment arms
- To compare use of concomitant medication between treatment arms.
- To compare premature treatment discontinuation (timing and reason) between treatment arms.
- To compare changes in suicidal ideation between treatment arms.
Conditions and MedDRA coding
Major depressive disorder
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10081270 | Major depressive disorder | 10037175 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Randomisation during the entire study After it is confirmed during the screening visit that the patient is eligible (and reconfirmed during visit 2), patient can be randomised. The randomisation is applicable for the entire study.
|
Randomised Controlled | Single | [{"id":168953,"code":2,"name":"Investigator"}] | Early intensified pharmacologiclal treatment (EIPT): Switch to esketamine nasal spray or esketamine infusion or ketamine infusion PLUS an oral antidepressant (all oral antidepressants are allowed except MAOIs). Treatment as usual (TAU): An oral antidepressant (all allowed, except MAOIs) |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- In- or out patients, at least 18 years of age up until 65.
- Being willing and able to provide written informed consent. Having a legal guardian to cosign is allowed. Informed consent will be signed at visit 1, before any study procedure.
- Female participants of child bearing potential must use effective contraception during the trial as per the requirements of the applicable SmPCs and should have a negative pregnancy test at visit 1 or 2 (before randomisation)
- Meeting diagnostic criteria for a primary diagnosis of major depressive disorder (without psychotic features), according to DSM-5. The primary diagnosis will be confirmed by the Mini International Neuropsychiatric Interview (MINI v7.0.2).
- Participant experiences a current treatment failure due to lack of efficacy in the current episode, as confirmed by a CGI-I ≥3y; preferably this treatment is a first-line pharmacotherapeutic agent for the primary DSM-5 diagnosis, and was prescribed for at least 4 weeks within an effective dose range as specified in the Summary of Product Characteristics (SmPCs). However, other treatments are accepted.
- Participant and clinician intend to change pharmacotherapeutic treatment.
- A minimum symptom severity threshold needs to be present (moderate level; see below) and participant needs to experience functional impairment. - The minimum symptom severity threshold is at least 2 PANSS positive or negative items with a score of 4, or at least one PANSS positive or negative item with a score of 5 - Functional impairment is defined as a score of 5 or higher on any of the three scales of the Sheehan Disability Scale (SDS).
Exclusion criteria 10
- Being pregnant or breastfeeding.
- Participant meets criteria for current substance use disorder, as confirmed by the Mini International Neuropsychiatric Interview (MINI v7.0.2). Nicotine dependency is allowed, as well as mild and moderate alcohol and/or cannabis use disorder (as defined by MINI v7.0.2). Severe alcohol and/or cannabis use disorder are not allowed.
- Participants dependent on the sponsor, investigator or trial site must be excluded from participation in advance.
- Participants have not been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
- Participant has used (es)ketamine previously for the treatment of depressive symptoms.
- Participant has a known intolerance to (es)ketamine or to all TAU medication options.
- Meeting any of the contraindications for (es)ketamine or to all TAU medication options, as specified within the applicable SmPC, supported by clinically significant abnormal values on local laboratory tests, electrocardiogram (ECG) or physical examinations.
- Participant has participated in another clinical trial in which the subject received an experimental or investigational drug or agent within 30 days before visit 1.
- Participant experiences any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.
- Participants with active suicidal ideation with some intent to act, without specific plan (“Yes” to question 4 of the Columbia-Suicide Severity Rating Scale (C-SSRS)) or active suicidal ideation with specific plan and intent (“Yes” to question 5 of the C-SSRS), followed by an assessment by the treating clinician who determines it is not safe for the subject to participate in the study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Mean change from baseline (visit 2) in symptom severity as measured by the MADRS total score at six weeks (visit 4) will be compared between the two treatment arms (EIPT vs. TAU) for the lines of treatment separately (subgroup analysis wherein the focus will be on participants who had a first time treatment failure on their first-line treatment) and for the group as a whole (irrespective of line of treatment).
Secondary endpoints 9
- 1.a. Change from baseline (visit 2) in the severity sub-score of the Clinical Global Impression Scale (CGI) at visit 4; EIPT vs TAU. 1.b. Improvement sub-score of the Clinical Global Impression Scale (CGI) at visit 4; EIPT vs TAU.
- Changes from baseline (visit 2) in total Hospital Anxiety and Depression Scale (HADS) total score and anxiety and depression subscales at visit 4; EIPT vs TAU.
- Change from baseline (visit 2) in quality of life and functioning measures (Q-LES-Q-SF, LAPS, QLS-100 and SDS ) at visit 4; EIPT vs TAU.
- Changes from baseline (visit 2) on Trail Making Test, Digit Symbol Substitution Test, Rey Auditory Verbal Learning Test as well as the Perceived Deficits Questionnaire at visit 4; EIPT vs TAU.
- Presence of symptomatic remission at visit 4; EIPT vs TAU. Remission is defined as a MADRS score ≤ 12.
- Presence of reported side effects as measured through General Assessment of Side Effects Scale (GASE) and reported spontaneously throughout the studyat visit 4; EIPT vs TAU.
- Concomitant medication use throughout the studyat visit 4; EIPT vs TAU.
- Premature treatment discontinuation before visit 4 and time to treatment discontinuation and reported reason of discontinuation; EIPT vs TAU.
- Changes on the Columbia-Suicide Severity Rating Scale (C-SSRS) throughout the study; EIPT vs TAU
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
SCP20043393 · ATC
- Active substance
- Esketamine
- Route of administration
- INFUSION
- Max daily dose
- 1 mg/kg milligram(s)/kilogram
- Max total dose
- 8 mg/kg milligram(s)/kilogram
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- N01AX14 — ESKETAMINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP8137199 · ATC
- Active substance
- Ketamine
- Route of administration
- INFUSION
- Max daily dose
- 1 mg/kg milligram(s)/kilogram
- Max total dose
- 8 mg/kg milligram(s)/kilogram
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- N01AX03 — KETAMINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP40218665 · ATC
- Active substance
- Esketamine
- Route of administration
- NASAL SPRAY
- Max daily dose
- 84 mg milligram(s)
- Max total dose
- 672 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- N06AX27 — ESKETAMINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 24
SCP146678 · ATC
- Active substance
- Bupropion Hydrochloride
- Substance synonyms
- AMFEBUTAMONE HYDROCHLORIDE
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 12600 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N06AX12 — BUPROPION
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP157726 · ATC
- Active substance
- Tianeptine
- Route of administration
- ORAL
- Max daily dose
- 37.5 mg milligram(s)
- Max total dose
- 1575 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N06AX14 — TIANEPTINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP11392530 · ATC
- Active substance
- Fluoxetine Hydrochloride
- Substance synonyms
- N-METHYL-3-PHENYL-3-[4-(TRIFLUOROMETHYL)PHENOXY]PROPAN-1-AMINE HYDROCHLORIDE
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 2520 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N06AB03 — FLUOXETINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP132295 · ATC
- Active substance
- Imipramine Hydrochloride
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 8400 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N06AA02 — IMIPRAMINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP15642028 · ATC
- Active substance
- Nortriptyline Hydrochloride
- Route of administration
- ORAL
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 6300 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N06AA10 — NORTRIPTYLINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1134849 · ATC
- Active substance
- Sertraline Hydrochloride
- Substance synonyms
- (1S,4R)-4-(3,4-DICHLOROPHENYL)-N-METHYL-TETRALIN-1-AMINE HYDROCHLORIDE
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 8400 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N06AB06 — SERTRALINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP185181 · ATC
- Active substance
- Agomelatine
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 2100 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N06AX22 — AGOMELATINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1062764 · ATC
- Active substance
- Desvenlafaxine Benzoate
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 8400 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N06AX23 — DESVENLAFAXINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP177814 · ATC
- Active substance
- Milnacipran Hydrochloride
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 4200 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N06AX17 — MILNACIPRAN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1150583 · ATC
- Active substance
- Trazodone
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 12600 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N06AX05 — TRAZODONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP12711734 · ATC
- Active substance
- Duloxetine
- Route of administration
- ORAL
- Max daily dose
- 120 mg milligram(s)
- Max total dose
- 5040 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N06AX21 — DULOXETINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1113263 · ATC
- Active substance
- Venlafaxine
- Route of administration
- ORAL
- Max daily dose
- 375 mg milligram(s)
- Max total dose
- 15750 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N06AX16 — VENLAFAXINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP128440 · ATC
- Active substance
- Clomipramine Hydrochloride
- Substance synonyms
- 3-CHLORO-10,11-DIHYDRO-N,N-DIMETHYL-5H-DIBENZO[B,F]AZEPINE-5-PROPANAMINE HYDROCHLORIDE
- Route of administration
- ORAL
- Max daily dose
- 250 mg milligram(s)
- Max total dose
- 10500 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N06AA04 — CLOMIPRAMINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP129073 · ATC
- Active substance
- Paroxetine Hydrochloride
- Substance synonyms
- ANHYDROUS PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE ANHYDROUS, (3S,4R)-3-(BENZO[1,3]DIOXOL-5-YLOXYMETHYL)-4-(4-FLUOROPHENYL)PIPERIDINE HYDROCHLORIDE, PAROXETINE HCL
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 2100 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N06AB05 — PAROXETINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP126890 · ATC
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 12600 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N06AB08 — FLUVOXAMINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP130720 · ATC
- Active substance
- Mirtazapine
- Substance synonyms
- ORG-3770
- Route of administration
- ORAL
- Max daily dose
- 45 mg milligram(s)
- Max total dose
- 1890 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N06AX11 — MIRTAZAPINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP128780 · ATC
- Active substance
- Dosulepin Hydrochloride
- Substance synonyms
- DOTHIEPIN HYDROCHLORIDE
- Route of administration
- ORAL
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 6300 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N06AA16 — DOSULEPIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP133764 · ATC
- Active substance
- Atomoxetine
- Substance synonyms
- TOMOXETINE
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 4200 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N06BA09 — ATOMOXETINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP139062 · ATC
- Active substance
- Mianserin Hydrochloride
- Route of administration
- ORAL
- Max daily dose
- 90 mg milligram(s)
- Max total dose
- 3780 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N06AX03 — MIANSERIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1124803 · ATC
- Active substance
- Citalopram Hydrobromide
- Substance synonyms
- 1-(3-DIMETHYLAMINOPROPYL)-1-(4-FLUOROPHENYL)-3H-2-BENZOFURAN-5-CARBONITRILE HYDROBROMIDE, NITALAPRAM HYDROBROMIDE
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 1680 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N06AB04 — CITALOPRAM
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP12617750 · ATC
- Active substance
- Amitriptyline Hydrochloride
- Route of administration
- ORAL
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 6300 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N06AA09 — AMITRIPTYLINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP156002 · ATC
- Active substance
- Reboxetine
- Route of administration
- ORAL
- Max daily dose
- 12 mg milligram(s)
- Max total dose
- 504 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N06AX18 — REBOXETINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP180456 · ATC
- Active substance
- Vortioxetine
- Substance synonyms
- AA21004
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 840 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N06AX26 — VORTIOXETINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1121256 · ATC
- Active substance
- Citalopram
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 840 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N06AB10 — ESCITALOPRAM
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Medisch Centrum Utrecht
- Sponsor organisation
- Universitair Medisch Centrum Utrecht
- Address
- Heidelberglaan 100
- City
- Utrecht
- Postcode
- 3584 CX
- Country
- Netherlands
Scientific contact point
- Organisation
- Universitair Medisch Centrum Utrecht
- Contact name
- Dr. Inge Winter
Public contact point
- Organisation
- Universitair Medisch Centrum Utrecht
- Contact name
- Dr. Inge Winter
Third parties 4
| Organisation | City, country | Duties |
|---|---|---|
| Fraunhofer-Institut für Algorithmen und Wissenschaftliches ORL-000000325
|
Sankt Augustin, Germany | E-data capture |
| Castor EDC ORL-000011984
|
Amsterdam, Netherlands | Other |
| Ludwig Maximilian University Of Munich ORG-100028102
|
Munich, Germany | Other |
| Kairos ORL-000000063
|
Bochum, Germany | E-data capture |
Locations
5 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 20 | 1 |
| Germany | Ongoing, recruiting | 180 | 4 |
| Greece | Authorised, recruitment pending | 35 | 1 |
| Italy | Ongoing, recruiting | 110 | 4 |
| Spain | Ongoing, recruiting | 15 | 1 |
| Rest of world
Israel, United Kingdom, Australia
|
— | 93 | — |
Investigational sites
Medical University Of Innsbruck
Universitätsklinik für Psychiatrie I (University Clinic for Psychiatry I), Anichstrasse 35, 6020, Innsbruck
Westfaelische Wilhelms-Universitaet Muenster
Klinik für Psychische Gesundheit, Albert-Schweitzer-Campus 1, Sentrup, Muenster
University Hospital Frankfurt am Main
Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, Heinrich-Hoffmann-Strasse 10, 60528, Frankfurt am Main
Universitätsklinik für Psychiatrie und Psychotherapie Bielefeld
Psychiatrie und Psychotherapy, Remterweg 69/71, 33617, Bielefeld
Lwl-Klinik Dortmund
Psychiatry, Marsbruchstrasse 179, Aplerbeck, Dortmund
Eginitio Hospital
First Department of Psychiatry, Vassilissas Sofias Avenue 74, 115 28, Athens
Università degli studi della Campania Luigi Vanvitelli
Dipartemento di salute mentale e fisica e medicina preventiva, Largo Madonna delle Grazie 1, 80138, Naples
University Of Brescia
Department of Mental Health and Addiction Services, Piazza Del Mercato 15, 25121, Brescia
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Dipartimento di Neuroscienze, Sezione di Psichiatria, Via Cherasco 15, 10126, Turin
Clinica Psichiatrica, 1st floor
Clinica Psichiatrica, 1st floor, Via Romagna 16, 09127, Cagliari
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2025-02-06 | 2025-02-06 | |||
| Germany | 2024-08-29 | 2024-08-29 | |||
| Italy | 2024-11-27 | 2024-11-27 | |||
| Spain | 2025-12-10 | 2025-12-10 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 134 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-506617-21-00_SIGNED | 1.3 |
| Protocol (for publication) | D1_Protocol_EL_2023-506617-21-00 | 1.3 |
| Protocol (for publication) | D1_Research Protocol_2023-506617-21-00 | 1.3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements Poster_08_Munster | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_02_Innsbruck | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_14_Barcelona | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Athens_16 | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Germany | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Italy | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Poster2 | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material poster_02_Innsbruck | 1.2 |
| Recruitment arrangements (for publication) | K2_Recruitment material poster_14_Barcelona | 1.2 |
| Recruitment arrangements (for publication) | K2_Recruitment material poster_14_Barcelona_TC | 1.2 |
| Recruitment arrangements (for publication) | K2_Recruitment material poster_Germany | 1.2 |
| Recruitment arrangements (for publication) | K2_Recruitment material poster_Germany_TC | 1.2 |
| Recruitment arrangements (for publication) | K2_Recruitment material poster_Innsbruck_02_TC | 1.2 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Flyer_08_Munster | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Poster_Italy | 1.2 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Poster_Italy_TC | 1.2 |
| Recruitment arrangements (for publication) | K2_Site list Germany | 1.2 |
| Recruitment arrangements (for publication) | K2_Site list germany_TC | 1.2 |
| Subject information and informed consent form (for publication) | L1_ICF and SFF_general_redacted_clean | 1.3 |
| Subject information and informed consent form (for publication) | L1_ICF and SFF_general_TC_redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_ICF and SIS_privacygenetics_redaction | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF and SIS_privacygenetics_TC_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF and SSF_biobank_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF and SSF_privacy_redacted_noTC | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF and SSF_privacy_TC_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_14_Barcelona | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_14_Barcelona_TC | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_clean_redacted | 1.4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Germany_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Germany_TC_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_redacted_TC | 1.4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_TC_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L2_ Other information material_GP letter_redacted_clean | 1.3 |
| Subject information and informed consent form (for publication) | L2_ Other information material_GP letter_TC_redacted | 1.3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material patient card_02_Innsbruck | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material patient card_14_Barcelona | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material patient card_Germany_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material patient card_Germany_TC_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient card | 1.2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient card_Italy | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Agomelatine_English | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Amitriptyline_Austrian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Amitriptyline_German | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Amitriptyline_Italian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Amitriptyline_Spanish | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Atomoxetine_Austrian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Atomoxetine_German | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Atomoxetine_Italian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Atomoxetine_Spanish | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC bupropion_Austrian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC bupropion_German | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC bupropion_Italian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC bupropion_Spanish | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Citalopram_Austrian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Citalopram_German | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Citalopram_Italian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Citalopram_Spanish | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Clomipramine_Austrian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Clomipramine_German | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Clomipramine_Italian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Clomipramine_Spanish | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Desvenlafaxine_Austrian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Desvenlafaxine_German | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Desvenlafaxine_Italian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Desvenlafaxine_Spanish | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Dosulepine_German | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Dosulepine_Italian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Duloxetine_Austrian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Duloxetine_German | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Duloxetine_Italian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Duloxetine_Spanish | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Escitalopram_Austrian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Escitalopram_German | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Escitalopram_Italian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Escitalopram_Spanish | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Esketamine IV | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Esketamine nasal spray | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Fluoxetine_Austrian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Fluoxetine_German | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Fluoxetine_Italian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Fluoxetine_Spanish | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Fluvoxamine_Austrian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Fluvoxamine_German | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Fluvoxamine_Italian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Fluvoxamine_Spanish | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Imipramine_Spanish | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ketamine | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Mianserin_Austrian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Mianserin_German | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Mianserin_Italian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Mianserin_Spanish | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Milnacipran_Austrian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Milnacipran_German | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Mirtazapine_Austrian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Mirtazapine_German | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Mirtazapine_Italian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Mirtazapine_Spanish | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Nortriptyline_German | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Nortriptyline_Italian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Nortriptyline_Spanish | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Paroxetine_Austrian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Paroxetine_German | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Paroxetine_Italian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Paroxetine_Spanish | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Reboxetine_Austrian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Reboxetine_German | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Reboxetine_Italian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Reboxetine_Spanish | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Setraline_Austrian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Setraline_German | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Setraline_Italian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Setraline_Spanish | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Tianeptine_Austrian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Tianeptine_German | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Tianeptine_Spanish | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Trazodone_Austrian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Trazodone_German | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Trazodone_Italian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Trazodone_Spanish | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Venlafaxine_Austrian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Venlafaxine_German | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Venlafaxine_Italian | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Venlafaxine_Spanish | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Vortioxetine_English | NA |
| Synopsis of the protocol (for publication) | D1_Synopsis_AT_2023-506617-21-00 | 1.3 |
| Synopsis of the protocol (for publication) | D1_Synopsis_DE_2023-506617-21-00 | 1.3 |
| Synopsis of the protocol (for publication) | D1_Synopsis_EL_2023-506617-21-00 | 1.3 |
| Synopsis of the protocol (for publication) | D1_Synopsis_English_2023-506617-21-00 | 1.3 |
| Synopsis of the protocol (for publication) | D1_Synopsis_ES_2023-506617-21-00 | 1.3 |
| Synopsis of the protocol (for publication) | D1_Synopsis_IT_2023-506617-21-00 | 1.3 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-08 | Austria | Acceptable 2024-01-15
|
2024-01-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-22 | Acceptable | 2024-08-26 | |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2024-09-10 | 2024-12-04 | ||
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-09 | 2024-12-09 | ||
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-12-19 | Austria | 2024-12-19 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-20 | Austria | Acceptable 2025-04-14
|
2025-04-15 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-04-17 | Acceptable 2025-04-14
|
2025-04-17 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-10 | Austria | Acceptable 2026-02-02
|
2026-02-03 |