NCT07196501RecruitingPhase 3
A Study to Evaluate the Maintenance Effect of Osavampator as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Maintenance of Effect of NBI-1065845 as an Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
The primary objective of this study is to evaluate the efficacy of osavampator (previously NBI-1065845) compared with placebo as an adjunctive treatment in delaying relapse of depressive symptoms (maintenance of effect) in participants with MDD.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 550 (estimated)
- First submitted
- 19 Sept 2025
- Start date
- 18 Aug 2025
- Primary completion date
- 31 Jul 2028
- Lead sponsor
- Neurocrine Biosciences
- Diseases
- Depression
- NCT number
- NCT07196501
- EU CT number
- 2025-520541-72-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 550
- From 18 Aug 2025 to the primary completion date, 31 Jul 2028
- 57 sites in 11 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.
- Participants depressive symptoms have previously demonstrated nonresponse to electroconvulsive therapy (ECT) in the current major depressive episode.
- Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
Other
- Are considered by the investigator to be at imminent risk of suicide or injury to self or others.
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 and is willing to continue the same oral antidepressants at the same dose and frequency of administration throughout participation in the study.
- Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1).
- 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 (57)
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 |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Parkville | Australia | Recruiting |
| Medical Center Intermedica Ltd. Coordinator of this site? Confirm its status | Sofia | 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 |
| Medical Center Hera EOOD 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 | Calgary | Canada | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Kingston | Canada | 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 | Sherbrooke | Canada | Active, not recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Toronto | Canada | 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 Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hestia Palau S.L. Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | 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 | Ansan-si | South Korea | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Prywatne Gabinety Lekarskie „Promedicus” Anna Agnieszka Tomczak Coordinator of this site? Confirm its status | Białystok | Poland | Recruiting |
| Ośrodek Badań Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak, Małgorzata Trzaska Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Centrum Zdrowia Alcea Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Gyncentrum Sp. z o. o. Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Belgrade | Serbia | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Kovin | Serbia | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Kragujevac | Serbia | 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 | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Albuquerque | United States | Active, not recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Austin | United States | Active, not recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Bellaire | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Charlotte | 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 | Friendswood | United States | Terminated |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Glen Oaks | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Iowa City | United States | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Marrero | 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 | New Haven | 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 | Recruiting |
| 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 | Recruiting |
| 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 | Roanoke | United States | 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 | Wichita Falls | United States | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.