NCT06966401RecruitingPhase 3
Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
A Long-Term, Open-Label Study to Assess the Safety and Tolerability of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 850 (estimated)
- First submitted
- 30 Apr 2025
- Start date
- 16 Apr 2025
- Primary completion date
- 31 May 2029
- Lead sponsor
- Neurocrine Biosciences
- Diseases
- Depression
- NCT number
- NCT06966401
- EU CT number
- 2024-519423-24-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 850
- From 16 Apr 2025 to the primary completion date, 31 May 2029
- 137 sites in 23 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD.
Other
- Are considered by the investigator to be at imminent risk of suicide or injury to self or others.
- Other protocol defined inclusion and exclusion criteria apply.
Who the study is looking for
- Participant has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder.
- Participant has had an inadequate response to oral antidepressant treatments in the current episode of depression.
- Participant must have been taking oral antidepressants for at least 8 weeks prior to screening.
- Willing and able to comply with all study procedures and restrictions in the opinion of the investigator.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (137)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Carlton | Australia | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Anima Coordinator of this site? Confirm its status | Alken | Belgium | Recruiting |
| Az Sint-Lucas Coordinator of this site? Confirm its status | Brugge | Belgium | Recruiting |
| Meclinas Coordinator of this site? Confirm its status | Mechelen | Belgium | Recruiting |
| Medical Center Lifemed EOOD Coordinator of this site? Confirm its status | Kirdzhali | Bulgaria | Recruiting |
| Medical Center Mentalcare Ltd. Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Recruiting |
| Center For Mental Health Ruse EOOD Coordinator of this site? Confirm its status | Ruse | Bulgaria | Recruiting |
| Medical Center Intermedica Ltd. Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Medical Center Hera EOOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Medical Center Saint Naum EOOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Diagnostics-Consultancy Center Mladost M Varna OOD Coordinator of this site? Confirm its status | Varna | Bulgaria | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | North Vancouver | Canada | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Narodni Ustav Dusevniho Zdravi Coordinator of this site? Confirm its status | Klecany | Czechia | Recruiting |
| Psychiatricka ambulance MUDr Marta Ondrusova Coordinator of this site? Confirm its status | Kurim | Czechia | Recruiting |
| A-Shine s.r.o. Coordinator of this site? Confirm its status | Plzen 3 | Czechia | Recruiting |
| INEP medical s.r.o. Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Neuropsychiatrie Petrska s.r.o. Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Medical Services Prague S R O Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Praglandia s.r.o. Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Clintrial s.r.o. Coordinator of this site? Confirm its status | Prague 10 | Czechia | Recruiting |
| Marienthali Kliinik OÜ Coordinator of this site? Confirm its status | Tallinn | Estonia | Recruiting |
| Arstikeskus Confido AS Coordinator of this site? Confirm its status | Tallinn | Estonia | Recruiting |
| Tartu University Hospital Coordinator of this site? Confirm its status | Tartu Linn | Estonia | Recruiting |
| Hospital Universitario Fundación Alcorcón Coordinator of this site? Confirm its status | Alcorcón | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hestia Palau S.L. Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Savon Psykiatripalvelu Oy Coordinator of this site? Confirm its status | Kuopio | Finland | Recruiting |
| Oulu Mentalcare Oy Coordinator of this site? Confirm its status | Oulu | Finland | Recruiting |
| Mehilaeinen Oy Coordinator of this site? Confirm its status | Tampere | Finland | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Manchester | United Kingdom | Withdrawn |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Southampton | United Kingdom | Withdrawn |
| KBC Zagreb Coordinator of this site? Confirm its status | Grad Zagreb | Croatia | Recruiting |
| Clinic for psychiatry Sveti Ivan Coordinator of this site? Confirm its status | Grad Zagreb | Croatia | Recruiting |
| Klinika za psihijatriju Vrapce Coordinator of this site? Confirm its status | Grad Zagreb | Croatia | Recruiting |
| Poliklinika Solmed d.o.o. Coordinator of this site? Confirm its status | Grad Zagreb | Croatia | Recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Nyírő Gyula Országos Pszichiátriai és Addiktológiai Intézet Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Obudai Egeszseguegyi Centrum Kft. Coordinator of this site? Confirm its status | Budapest III | Hungary | Recruiting |
| Gyoengyosi Bugat Pal Koerhaz Coordinator of this site? Confirm its status | Gyongyos | Hungary | Recruiting |
| Dr. Mathe Es Tarsa Bt. Coordinator of this site? Confirm its status | Kalocsa | Hungary | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Saules seimos medicinos centras UAB Coordinator of this site? Confirm its status | Kaunas | Lithuania | Recruiting |
| Romuvos klinika UAB Coordinator of this site? Confirm its status | Kaunas | Lithuania | Recruiting |
| Respublikine Klaipedos ligonine VšĮ Coordinator of this site? Confirm its status | Klaipeda | Lithuania | Recruiting |
| Vilnius City Mental Health Center Coordinator of this site? Confirm its status | Vilnius | Lithuania | Recruiting |
| Lietuvos sveikatos mokslu universiteto Kauno ligonine Coordinator of this site? Confirm its status | Ziegzdriu K. | Lithuania | Recruiting |
| Slimnica Gintermuiza VSIA Coordinator of this site? Confirm its status | Jelgava | Latvia | Recruiting |
| L. Keruze practice in Psychiatry Coordinator of this site? Confirm its status | Liepaja | Latvia | Recruiting |
| Siguldas Slimnica Coordinator of this site? Confirm its status | Siguldas Pagasts | Latvia | Recruiting |
| Brain Research Center Amsterdam B.V. Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Completed |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Completed |
| Leids Universitair Medisch Centrum (LUMC) Coordinator of this site? Confirm its status | Leiden | Netherlands | Completed |
| Brain Research Center Den Bosch B.V. Coordinator of this site? Confirm its status | 's-Hertogenbosch | Netherlands | Completed |
| Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski Coordinator of this site? Confirm its status | Belchatow | Poland | Recruiting |
| MłynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Łazarczyk Coordinator of this site? Confirm its status | Białystok | Poland | Recruiting |
| Prywatne Gabinety Lekarskie „Promedicus” Anna Agnieszka Tomczak Coordinator of this site? Confirm its status | Białystok | Poland | Recruiting |
| Podlaskie Centrum Psychogeriatrii Coordinator of this site? Confirm its status | Bia?ystok | Poland | Recruiting |
| Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Centrum Badan Klinicznych PI-House sp. z o.o. Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Centrum Zdrowia Alcea Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Przychodnie Grudziadz sp. z o.o. Coordinator of this site? Confirm its status | Grudziądz | Poland | Recruiting |
| Clinic BBP Bożena Pawełczyk Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Care Clinic Sp. Z O.O. Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Osrodek Badan Klinicznych Clinsante s.c. Ewa Galczak-Nowak Malgorzata Trzaska Coordinator of this site? Confirm its status | Torun | Poland | Recruiting |
| Gyncentrum Sp. z o. o. Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Centru De Evaluare Si Tratament A Toxicodependentelor Pentru Tineri Sf. Stelian Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Institutul Privat de Cercetari Melchisedec, pentru Boli Autoimune, Ereditare si Rare - IPCM Coordinator of this site? Confirm its status | Craiova | Romania | Recruiting |
| Spitalul Clinic Judetean De Urgenta Bihor Coordinator of this site? Confirm its status | Oradea | Romania | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Belgrade | Serbia | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Kragujevac | Serbia | Recruiting |
| Sahlgrenska University Hospital-Vaestra Goetalandsregionen Coordinator of this site? Confirm its status | Gothenburg | Sweden | Recruiting |
| ProbarE i Lund AB Coordinator of this site? Confirm its status | Lund | Sweden | Recruiting |
| ProbarE i Stockholm AB Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
| Dana Ignjatovićová, spol. s r.o Coordinator of this site? Confirm its status | Banská Bystrica | Slovakia | Recruiting |
| Centrum Zdravia R.B.K. s.r.o. Coordinator of this site? Confirm its status | Bardejov | Slovakia | Recruiting |
| Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach Coordinator of this site? Confirm its status | Bojnice | Slovakia | Recruiting |
| Epamed s.r.o. Coordinator of this site? Confirm its status | Kosice - Zapad | Slovakia | Recruiting |
| PsychoLine s.r.o. Coordinator of this site? Confirm its status | Rimavska Sobota | Slovakia | Recruiting |
| Mentum s.r.o. Coordinator of this site? Confirm its status | Stare Mesto | Slovakia | Recruiting |
| Crystal Comfort S.R.O. Coordinator of this site? Confirm its status | Vranov nad Topľou | Slovakia | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Keelung | Taiwan | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Taipei | Taiwan | Withdrawn |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Avon Lake | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Bellaire | United States | Withdrawn |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Bryant | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Cedarhurst | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Chino | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Cromwell | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | DeSoto | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Draper | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Edmond | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Farmington | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Gaithersburg | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Glendale | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Hollywood | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Huntsville | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Maitland | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Miami Gardens | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Mount Kisco | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Oceanside | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | O'Fallon | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Oklahoma City | United States | Withdrawn |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Orlando | United States | Withdrawn |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Palm Bay | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Pico Rivera | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Richmond | United States | Withdrawn |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Saint Charles | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | San Francisco | United States | Active, not recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | San Jose | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Stafford | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | The Woodlands | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Upland | United States | Terminated |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Watertown | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.