Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
557
Countries
16
Sites
91
Major Depressive Disorder
To evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in subjects with MDD
Key facts
- Sponsor
- Neurocrine Biosciences Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 7 Oct 2025 → ongoing
- Decision date (initial)
- 2025-07-01
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Neurocrine Biosciences, Inc.
External identifiers
- EU CT number
- 2024-519423-24-00
- ClinicalTrials.gov
- NCT06966401
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy
To evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in subjects with MDD
Secondary objectives 1
- To evaluate the effects of NBI-1065845 in subjects with MDD on symptoms of depression, subject-reported, and ability to complete daily activities
Conditions and MedDRA coding
Major Depressive Disorder
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10081270 | Major depressive disorder | 10037175 |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Subject has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder.
- Subject has had an inadequate response to oral antidepressant treatments in the current episode of depression.
- Subject must have been taking oral antidepressants for at least 8 weeks and is willing to continue the same oral antidepressants at the same dose and frequency of administration throughout participation in the study.
- Total MADRS score ≥18 at screening.
- Willing and able to comply with all study procedures and restrictions in the opinion of the investigator.
Exclusion criteria 2
- A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD.
- Are considered by the investigator to be at imminent risk of suicide or injury to self or others.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The occurrence of adverse events (AEs) up to Week 52.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD9147748 · Product
- Active substance
- 9-4-CYCLOHEXYLOXYPHENYL-7-METHYL-34-DIHYDROPYRAZINO21-C124THIADIAZINE 22-DIOXIDE
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 156 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NEUROCRINE BIOSCIENCES INC
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Neurocrine Biosciences Inc.
- Sponsor organisation
- Neurocrine Biosciences Inc.
- Address
- 6027 Edgewood Bend Court
- City
- San Diego
- Postcode
- 92130-8235
- Country
- United States
Scientific contact point
- Organisation
- Neurocrine Biosciences Inc.
- Contact name
- Neurocrine Medical Information Call Center
Public contact point
- Organisation
- Neurocrine Biosciences Inc.
- Contact name
- Neurocrine Medical Information Call Center
Third parties 9
| Organisation | City, country | Duties |
|---|---|---|
| Signant Health Global LLC ORG-100040604
|
San Francisco, United States | Interactive response technologies (IRT) |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Epilepsy Study Consortium Inc. ORG-100043101
|
Reston, United States | Other |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | E-data capture |
| Massachusetts General Hospital ORG-100043739
|
Boston, United States | Other |
| Cytel Inc. ORG-100042560
|
Cambridge, United States | Other |
| Q Squared Solutions Limited ORG-100042527
|
Reading, United Kingdom | Laboratory analysis |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Code 12, Other, Code 2, Code 5 |
| Marken LLP ORG-100048834
|
Springfield Gardens, United States | Other |
Locations
16 EU/EEA countries · 91 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 10 | 3 |
| Bulgaria | Ongoing, recruiting | 42 | 10 |
| Croatia | Ongoing, recruiting | 18 | 8 |
| Czechia | Ongoing, recruiting | 21 | 8 |
| Estonia | Ongoing, recruiting | 5 | 3 |
| Finland | Ongoing, recruiting | 10 | 3 |
| Hungary | Authorised, recruiting | 13 | 5 |
| Italy | Authorised, recruitment pending | 5 | 3 |
| Latvia | Ongoing, recruiting | 7 | 3 |
| Lithuania | Ongoing, recruiting | 18 | 5 |
| Netherlands | Ended | 22 | 4 |
| Poland | Ongoing, recruiting | 32 | 16 |
| Romania | Authorised, recruiting | 16 | 5 |
| Slovakia | Ongoing, recruiting | 18 | 8 |
| Spain | Authorised, recruitment pending | 5 | 3 |
| Sweden | Ongoing, recruiting | 29 | 4 |
| Rest of world
United States, Serbia, Australia, Taiwan, United Kingdom, Korea, Republic of, Canada
|
— | 286 | — |
Investigational sites
Az Sint-Lucas
Psychiatry, Sint-Lucaslaan 29, 8310, Brugge
Meclinas
Psychiatry, Stationsstraat 102-108, 2800, Mechelen
Anima
Psychiatry, Alkerstraat 28, 3570, Alken
Medical Center Lifemed EOOD
N/A, 1st Floor, Ulitsa Ekzarh Yosif 14, Kirdzhali
Diagnostics-Consultancy Center Mladost M Varna OOD
N/A, Bulevard Republika 15, 9020, Varna
Medical Center Mentalcare Ltd.
N/A, Bulevard Aleksandir Stamboliyski 107, 4004, Plovdiv
Medical Center Hera EOOD
N/A, Ulitsa Klisura 20, 1510, Sofiya
Medical Center Intermedica Ltd.
N/A, Belite Brezi, Nishava Street 62, Sofia
Diagnostics-Consultancy Center Mladost M Varna OOD
N/A, Bulevard Republika 15, 9020, Varna
Center For Mental Health Ruse EOOD
Men Dep for treatm of persons with acute psychotic disorders, Women Dep for treatm of persons with, Bulevard Tutrakan 20, 7003, Ruse
Medical Center Hera EOOD
N/A, Ulitsa Klisura 20, 1510, Sofiya
Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OOD
N/A, Ulitsa Dimitir Manov 17, 1408, Sofiya
Medical Center Saint Naum EOOD
N/A, Ulitsa D-R Lyuben Rusev 1, 1113, Sofiya
KBC Zagreb
Psychiatry, Ulica Mije Kispatica 12, Zagreb, Grad Zagreb
Poliklinika Solmed d.o.o.
Poliklinika Solmed, Preradoviceva Ulica 20, Zagreb, Grad Zagreb
Poliklinika Neuron
Polyclinic Neuron, Salata 12, 10000, Grad Zagreb
Klinika za psihijatriju Vrapce
Biological Psychiatry and Psychogeriatrics, Bolnicka Cesta 32, Zagreb, Grad Zagreb
Clinic for psychiatry Sveti Ivan
Clinic for Psychiatry, Jankomir 11, Zagreb, Grad Zagreb
Klinika za psihijatriju Vrapce
Affective Disorders, Bolnicka Cesta 32, Zagreb, Grad Zagreb
KBC Zagreb
Psychiatry and Psychological medicine, Ulica Mije Kispatica 12, Zagreb, Grad Zagreb
Klinika za psihijatriju Vrapce
Psychiatry, Bolnicka Cesta 32, Zagreb, Grad Zagreb
A-Shine s.r.o.
Psychiatry, Sumavska 2, Vychodni Predmesti, Plzen 3
INEP medical s.r.o.
Psychiatry, Krizikova 264/22, Karlin, Prague
Neuropsychiatrie Petrska s.r.o.
Psychiatry, Petrska 1168/29, Nove Mesto, Prague
Clintrial s.r.o.
Psychiatry, Pocernicka 1427/16, Strasnice, Prague 10
Praglandia s.r.o.
Psychiatry, Nadrazni 3368/30a, Smichov, Prague
Narodni Ustav Dusevniho Zdravi
Psychiatry, Topolova 748, 250 67, Klecany
Medical Services Prague s.r.o.
Psychiatry, Kolejni 429/5, Dejvice, Prague
Psychiatricka ambulance MUDr Marta Ondrusova
Psychiatry, Blanenska 982/15, 664 34, Kurim
Arstikeskus Confido AS
N/A, Veerenni Tn 51, Kesklinna Linnaosa, Tallinn
Marienthali Kliinik OÜ
N/A, Kotka Tn 12, Kristiine Linnaosa, Tallinn
Tartu University Hospital
Psychiatry, Raja Tn 31, 50417, Tartu Linn
Mehilaeinen Oy
Satakunnan Psykiatripalvelu, Itainenkatu 3, 33210, Tampere
Savon Psykiatripalvelu Oy
Savon Psykiatripalvelu Oy, Asemakatu 46b 23, 70110, Kuopio
Oulu Mentalcare Oy
Oulu Mentalcare Oy, Isokatu 8 B 8, 90100, Oulu
Nyiro Gyula Orszagos Pszichiatriai Es Addiktologiai Intezet
"C" Pszichiátriai Osztály, Lehel Utca 59/XIII, XIII Kerulet, Budapest
Obudai Egeszseguegyi Centrum Kft.
-, Lajos Utca 74-76, 1036, Budapest III
Gyoengyosi Bugat Pal Koerhaz
Rehabilitációs Elmegyógyászati Osztály, Dozsa Gyorgy Utca 20-22, 3200, Gyongyos
Dr. Mathe Es Tarsa Bt.
-, Szechenyi Ut 8, 6300, Kalocsa
Semmelweis University
Pszichiatriai es Pszichoterapias Klinika, Balassa J Utca 6, 1083, Budapest
Ospedale San Raffaele S.r.l.
Mood Disorder Unit, Via Stamira D'ancona 20, 20127, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Psychiatry Department, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department of Neuroscience and Mental Health, Corso Bramante 88, 10126, Turin
Siguldas Slimnica
N/A, Ziedu Iela 5, 2150, Siguldas Pagasts
L. Keruze practice in Psychiatry
N/A, Republikas street 5, LV-3401, Liepaja
Slimnica Gintermuiza VSIA
N/A, Filozofu Iela 69, 3008, Jelgava
Romuvos klinika UAB
psichiatrijos, Rotuses A. 23, Kauno M. Sav., Kaunas
Saules seimos medicinos centras UAB
psichiatrijos, Partizanu G. 27d, Kauno M. Sav., Kaunas
Lietuvos sveikatos mokslu universiteto Kauno ligonine
psichiatrijos, A. Krisciuno G. 2, Kauno R. Sav., Ziegzdriu K.
Respublikine Klaipedos ligonine VšĮ
psichiatrijos, Bangu Street 6A, 91251, Klaipeda
Vilnius City Mental Health Center
psichiatrijos, Vasaros G. 5, Vilniaus M. Sav., Vilnius
Brain Research Center Den Bosch B.V.
Psychiatry, Statenlaan 37, 5223 LA, 's-Hertogenbosch
Universitair Medisch Centrum Groningen
Psychiatry, Hanzeplein 1, 9713 GZ, Groningen
Leids Universitair Medisch Centrum (LUMC)
Psychiatry, Albinusdreef 2, 2333 ZA, Leiden
Brain Research Center Amsterdam B.V.
Psychiatry, Cronenburg 2, 1081 GN, Amsterdam
Care Clinic Sp. z o.o.
Care Clinic Centrum Medyczne, Ul. Ligocka 103, 40-568, Katowice
Centrum Zdrowia Alcea
N/A, Matemblewska 1A/17, 80-283, Gdansk
Gyncentrum Sp. z o.o.
NZOZ GynCentrum - Oddział Warszawa, Rondo Organizacji Narodow Zjednoczonych 1, 00-124, Warsaw
Centrum Medyczne Luxmed Sp. z o.o.
N/A, Ul. Krolewska 11, 20-109, Lublin
Centrum Badan Klinicznych Pi-House Sp. z o.o.
N/A, Ul. Na Zaspe 3, 80-546, Gdansk
Prywatne Gabinety Lekarskie „Promedicus” Anna Agnieszka Tomczak
N/A, Ul. Świętego Rocha 13/15, lok.221, Białystok
Osrodek Badan Klinicznych Clinsante s.c. Ewa Galczak-Nowak, Malgorzata Trzaska
Ośrodek Badań Klinicznych Clinsante, Ul. Konstantego Ildefonsa Gałczynskiego 45, 87-100, Torun
MłynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Łazarczyk
N/A, Młynowa 38 lok 13U, 15-404, Białystok
Osrodek Badan Klinicznych Clinsante s.c. Ewa Galczak-Nowak Malgorzata Trzaska
Ośrodek Badań Klinicznych Clinsante, ul. Tytusa Chałubińskiego 6, 85-794, Bydgoszcz
Wojewódzki Szpital Zdrowia Psychicznego im. Dr Józefa Bednarza w Świeciu
Oddział Leczenia Zespołów Abstynencyjnych po Substancjach Psychoaktywnych XIV (Detoksykacji), ul. Sądowa 18, 86-100, Świecie
Podlaskie Centrum Psychogeriatrii
N/A, ul. Swobodna 38 lok 9, 15-756, Białystok
Niepubliczny Zaklad Opieki Zdrowotnej Euromedica Sp. z o.o.
Niepubliczny Zakład Opieki Zdrowotnej Euromedica, Ul. Dabrowki 1, 86-300, Grudziadz
Clinic BBP Bożena Pawełczyk
N/A, Ceglana 65c/64, 40-514, Katowice
Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
N/A, Kazimierza Karasia 20, 64-100, Leszno
Indywidualna Praktyka Lekarska Kinga Bobinska
N/A, Henryka Sienkiewicza 59/31, 90-009, Lodz
Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski
N/A, ul. Kotarbińskiego 14, 97-400, Belchatow
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Psihiatrie Clinica III, Soseaua Berceni 10, 041915, Bucharest
Spitalul Clinic Judetean De Urgenta Bihor
Psihiatrie II, Strada Pasteur Louis Nr 26, 410154, Oradea
Institutul Privat de Cercetari Melchisedec, pentru Boli Autoimune, Ereditare si Rare - IPCM
Psihiatrie, Strada Amarandia nr. 21, 200157, Craiova
Centru De Evaluare Si Tratament A Toxicodependentelor Pentru Tineri Sf. Stelian
Psihiatrie, Strada Ing Cristian Pascal 25-27 Sector 6, 060222, Bucharest
Spitalul Clinic De Psihiatrie Si Neurologie Brasov
Psihiatrie Clinica III, Str Meschendorfer Nr 443a, 507190, Sanpetru
Centrum Zdravia R.B.K. s.r.o.
Psychiatricka ambulancia, Site address: MUDr. Pribulu 463/15, 089 01 Svidnik, Slovak Republic, Pod Papiernou 1286/4, 085 01, Bardejov
Nemocnica S Poliklinikou Prievidza So Sidlom V Bojniciach
Psychiatricke oddelenie, Nemocnicna 2, 972 01, Bojnice
Univerzitna nemocnica L. Pasteura Kosice
II. Psychiatricka klinika, Rastislavova 43, Juh, Kosice
Epamed s.r.o.
Psychiatricka ambulancia, Site Address: Hlavna 68, 040 01 Kosice, Slovak Republic, Topasova 9, Zapad, Kosice - Zapad
Crystal Comfort s.r.o.
Psychiatricka ambulancia, M R Stefanika 2427, 093 01, Vranov Nad Toplou
Dana Ignjatovičová, spol. s.r.o.,
Psychiatricka ambulancia, Site address:Cesta k nemocnici 1231/23, 974 01 Banska Bystrica, Slovakia, Bakossova 1693/36, 974 01, Banská Bystrica
Mentum s.r.o.
Psychiatricka ambulancia, Site address: Ruzinovska 10, 820 07 Bratislava, Slovak Republic, Javorinska 1958/2, 811 03, Stare Mesto
PsychoLine s.r.o.
Psychiatricka ambulancia, P. Dobsinskeho 4861, 979 01, Rimavska Sobota
Hestia Palau S.L.
Psychiatry, Calle De San Antonio Maria Claret 135, 08025, Barcelona
Hospital Universitari Vall D Hebron
Psychiatry, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Fundacion Alcorcon
Psychiatry, Calle Budapest 1, 28922, Alcorcon
Region Skane Helsingborg Hospital
Institutionen för kliniska vetenskaper, Charlotte Yhlens Gata 10, Helsingborgs Maria, Helsingborg
ProbarE i Lund AB
ProbarE i Lund AB, S Domkyrkofors., Lilla Fiskaregatan 10, Lund
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
SU/Affektiva FoU-avdelningen, Diagnosvagen 11, Harlanda, Gothenburg
ProbarE i Stockholm AB
ProbarE i Stockholm AB, Vegagatan 8, Gustav Vasa, Stockholm
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 |
|---|---|---|---|---|---|
| Belgium | 2025-10-29 | 2025-11-18 | |||
| Bulgaria | 2025-12-03 | 2026-01-14 | |||
| Croatia | 2025-11-26 | 2026-01-08 | |||
| Czechia | 2025-12-11 | 2026-02-02 | |||
| Estonia | 2026-03-23 | 2026-04-29 | |||
| Finland | 2025-11-13 | 2025-12-22 | |||
| Hungary | 2026-03-25 | ||||
| Latvia | 2025-12-17 | 2026-02-04 | |||
| Lithuania | 2026-03-10 | 2026-04-08 | |||
| Netherlands | 2025-10-10 | 2025-12-17 | |||
| Poland | 2025-11-26 | 2025-12-21 | |||
| Romania | 2026-02-10 | ||||
| Slovakia | 2026-01-13 | 2026-03-19 | |||
| Sweden | 2025-10-07 | 2025-10-15 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 153 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-519423-24-00_redacted | Am2.1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 1_publication statement | NA |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 1_publication statement | NA |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 2_publication statement | NA |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 2_publication statement | NA |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 3_publication statement | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 3_publication statement | NA |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 4_publication statement | NA |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 4_publication statement | NA |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 5_publication statement | NA |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 5_publication statement | NA |
| Recruitment arrangements (for publication) | K0_Cover letter_Bulgaria_Part II_IN_placeholder_san | N/A |
| Recruitment arrangements (for publication) | K0_Cover letter_Bulgaria_Part II_SM-8_placeholder_san | N/A |
| Recruitment arrangements (for publication) | K1_NBI-1065845-MDD3028_Recruitment Arrangements NL | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure_san | v1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements omission justification_san | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BG_san | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_EN_san | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_san | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_san | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_san | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_san | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_san | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_San | Italy_V1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Brochure_CZ_red and san | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment Brochure_HR_red_san | V1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment Brochure_HU_redacted_san | V2.1 |
| Recruitment arrangements (for publication) | K1_Recruitment Brochure_lv_red_san | V2.1 |
| Recruitment arrangements (for publication) | K1_Recruitment procedures | 1 |
| Recruitment arrangements (for publication) | K2_1_Recruitment Brochure_BG_red_san | 2.1 |
| Recruitment arrangements (for publication) | K2_NBI-1065845-MDD3028_BRC_Link2Trial social media recruitment tools MDD_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_NBI-1065845-MDD3028_Recruitment Brochure_NLD_red-san | 1.1 |
| Recruitment arrangements (for publication) | K2_NBI-1065845-MDD3028_Site 2701_BRC_Presentation_Red_San | V1 |
| Recruitment arrangements (for publication) | K2_NBI-1065845-MDD3028_Site 2701_BRC_Website_Red_San | V2 |
| Recruitment arrangements (for publication) | K2_Recruitment Brochure_EN_redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Brochure_RO_redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_EEet_redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_EEru_redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_PL_redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Brochure_red-san | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Brochure_Red-San | V1.1 IT-IT |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Brochure_redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment brochure_redacted | v1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Brochure_Redacted | V1.2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Main ICF_red and san | V4.0CZE1.0 |
| Subject information and informed consent form (for publication) | L1_1_1_SIS and ICF Main Master ICF_red_san | 4.0 |
| Subject information and informed consent form (for publication) | L1_1_2_ SIS and ICF Main ICF_EN_red_san | 1.0 |
| Subject information and informed consent form (for publication) | L1_1_2_SIS and ICF Main ICF_EN_red_san | 1.0 |
| Subject information and informed consent form (for publication) | L1_1_3_ SIS and ICF Main ICF_BG_red_san | V4.0BGR1.0 |
| Subject information and informed consent form (for publication) | L1_1_3_SIS and ICF Main ICF_BG_red_san | V4.0BGR1.0 |
| Subject information and informed consent form (for publication) | L1_2_1_SIS and ICF Pregnant Partner Master ICF_red_san | 1.0 |
| Subject information and informed consent form (for publication) | L1_2_2_SIS and ICF_Pregnant Partner ICF_EN_red_san | 1.0 |
| Subject information and informed consent form (for publication) | L1_2_3_SIS and ICF_Pregnant Partner ICF_BG_red_san | V1.0BGR1.0 |
| Subject information and informed consent form (for publication) | L1_Croatia_FSR ICF_HR_Clean_san | V4.0HRV1.0 |
| Subject information and informed consent form (for publication) | L1_Croatia_Main ICF_HR_Clean_redacted | V4.0HRV1.0 |
| Subject information and informed consent form (for publication) | L1_Croatia_Marken DTP Shipping Services ICF_Clean_san | V2.0HRV1.0 |
| Subject information and informed consent form (for publication) | L1_Croatia_Pregnant Partner ICF_clean_redacted | V1.0HRV3.0 |
| Subject information and informed consent form (for publication) | L1_Croatia_Pregnant Subject ICF_Clean_redacted | V1.0HRV3.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main_Redacted | V4.0ESP3.0 |
| Subject information and informed consent form (for publication) | L1_NBI-1065845-MDD3028_Main ICF_NLD_red_san | V4.0NLD1.0 |
| Subject information and informed consent form (for publication) | L1_NBI-1065845-MDD3028_Pregnancy ICF_NLD_red_san | V1.0NLD2.0 |
| Subject information and informed consent form (for publication) | L1_PP ICF_Redacted | V1.0ESP2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF FSR audio recordings | V2.0FIN1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF FSR_lt | 3.0LTU1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Appendix_redacted | V4.0FIN1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF_redacted | V3.0FIN1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_EST et_redacted | V4.0EST2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_EST ru_redacted | V4.0EST2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_hu_san_redacted | V4.0HUN1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_lt_redacted | V4.0LTU2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_lv_red_san | V4.0LAT2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_red-san | V4.0SVK1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_ru_red_san | V4.0LAT2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PP_lv_red_san | V1.0LAT2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PP_ru_red_san | V1.0LAT2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy ICF | V1.0FIN2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_red-san | V1.0SVK2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_EST et_redacted | V1.0EST3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_EST ru_redacted | V1.0EST3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_hu_san_redacted | V1.0HUN1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_lt_redacted | 1.0LTU2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Privacy to Main_red-san | V4.0SVK1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ ICF_Main ICF_redacted | V4.0SWE1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research_en | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research_ro | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Privacy_San | V4.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_en_red | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_EN_redacted | 4.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_FR_redacted | 4.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_NL_redacted | 4.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_redacted | V4.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_ro_red | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_San_Red-San | V4.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional FRS_San | V4.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy Follow up_ro_red | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy Follow-up ICF_redacted | 1.0SWE1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy Follow-up_EN_redacted | 1.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy Follow-up_FR_redacted | 1.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy Follow-up_NL_redacted | 1.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_Red-San | V2.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Follow Up_en_red | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Sponsor statement_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_ SIS and ICF_Future Use of Audio Recordings ICF_san | V4.0CZE1.0 |
| Subject information and informed consent form (for publication) | L2_ SIS and ICF_Main GDPR ICF_san | CZE2.0 |
| Subject information and informed consent form (for publication) | L2_ SIS and ICF_Pregnancy ICF_red and san | V1.0CZE1.0 |
| Subject information and informed consent form (for publication) | L2_ICF_Pregnancy Follow-up_redacted | V1.0POL2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Data processing description | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Mural Health Privacy Policy_red-san | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Mural Health Terms and Conditions | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Mural Health_Participant Reference Guide_cs_san | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Mural Link Participant App Fun Facts | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Mural Link Participant Reference Guide | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Notifications for Mural Link | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant ID Card_EEet_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant ID Card_EEru_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant ID card_red and san | V2.0_CS-CZ |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant ID Card_red-san | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Training_publication statement | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Questionnaire 6_publication statement | N/A |
| Subject information and informed consent form (for publication) | L2_Patient ID card_hu_redacted_san | 2.1 |
| Subject information and informed consent form (for publication) | L3_Mural Link Participant App Fun Facts v1_0-HU_san | 1 |
| Subject information and informed consent form (for publication) | L3_Mural Link Participant Mobile Web and App Screenshots_san | V1.0 |
| Subject information and informed consent form (for publication) | L3_Mural Link Participant Reference Guide v1_0-HU_san | 1 |
| Subject information and informed consent form (for publication) | L3_Notifications for Mural Link-HU_san | 1 |
| Subject information and informed consent form (for publication) | L3_Participant Training_publication statement_san | 1 |
| Subject information and informed consent form (for publication) | L3_Patient-facing_Questionnaire 6_publication statement_san | 1 |
| Subject information and informed consent form (for publication) | L3_Placeholder_Tablet UI_san | 1 |
| Subject information and informed consent form (for publication) | L3_Placeholder_Web Patient User Guide_san | 1 |
| Subject information and informed consent form (for publication) | L3_Placeholder_Web UI_Screenshots_san | 1 |
| Subject information and informed consent form (for publication) | L3_Privacy Policy 6-2023-HU_redacted_san | 1 |
| Subject information and informed consent form (for publication) | L3_Terms and Conditions 10_2023-HU_san | 1 |
| Subject information and informed consent form (for publication) | L4_List of submitted documents_placeholder_san | 1 |
| Subject information and informed consent form (for publication) | L4_List of submitted documents_SM-10_en_hu_san | SM-10 |
| Synopsis of the protocol (for publication) | D1_Protocol scientific synopsis_2024-519423-24-00_IT_Redacted | Am2.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-519423-24-00_BE-de_redacted | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-519423-24-00_BE-fr_redacted | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-519423-24-00_BE-nl_redacted | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-519423-24-00_BG_redacted | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-519423-24-00_CZ_redacted | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-519423-24-00_EN_redacted | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-519423-24-00_HU_redacted | NA |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-519423-24-00_IT_Redacted | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-519423-24-00_LT_redacted | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-519423-24-00_NL_redacted | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-519423-24-00_PL_redacted | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-519423-24-00_RO_redacted | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-519423-24-00_SE_redacted | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-519423-24-00_SK_redacted | NA |
Application history
16 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-12 | Poland | Acceptable 2025-06-30
|
2025-07-01 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-14 | Poland | Acceptable 2025-06-30
|
2025-07-14 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-07-16 | Acceptable 2025-06-30
|
2025-07-16 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-07-21 | Acceptable 2025-06-30
|
2025-07-21 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-07-23 | Poland | Acceptable 2025-06-30
|
2025-07-23 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-23 | Acceptable | 2025-08-28 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-07-23 | Acceptable | 2025-07-31 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-07-23 | Acceptable | 2025-08-21 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-07-23 | Acceptable | 2025-07-28 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-09-16 | Poland | Acceptable 2025-11-07
|
2025-11-07 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-12-11 | Poland | Acceptable 2025-11-07
|
2025-12-11 |
| 12 | SUBSEQUENT ADDITION OF MSC | APP-12 | 2025-12-16 | Acceptable 2025-11-07
|
2026-02-13 | |
| 13 | SUBSEQUENT ADDITION OF MSC | APP-13 | 2025-12-16 | Acceptable 2025-11-07
|
2026-01-21 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-9 | 2026-01-09 | Acceptable | 2026-02-06 | |
| 15 | SUBSEQUENT ADDITION OF MSC | APP-15 | 2026-01-12 | Acceptable 2025-11-07
|
2026-03-27 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-10 | 2026-02-11 | Acceptable | 2026-03-25 |