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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

Full criteria on ClinicalTrials.gov

Sites (57)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Neurocrine Clinical Site
Coordinator of this site? Confirm its status
CarltonAustraliaRecruiting
Neurocrine Clinical Site
Coordinator of this site? Confirm its status
MelbourneAustraliaRecruiting
Neurocrine Clinical Site
Coordinator of this site? Confirm its status
ParkvilleAustraliaRecruiting
Medical Center Intermedica Ltd.
Coordinator of this site? Confirm its status
SofiaBulgariaRecruiting
Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OOD
Coordinator of this site? Confirm its status
SofiyaBulgariaRecruiting
Medical Center Hera EOOD
Coordinator of this site? Confirm its status
SofiyaBulgariaRecruiting
Diagnostics-Consultancy Center Mladost M Varna OOD
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VarnaBulgariaRecruiting
Neurocrine Clinical Site
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CalgaryCanadaRecruiting
Neurocrine Clinical Site
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KingstonCanadaRecruiting
Neurocrine Clinical Site
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North VancouverCanadaRecruiting
Neurocrine Clinical Site
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SherbrookeCanadaActive, not recruiting
Neurocrine Clinical Site
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TorontoCanadaRecruiting
Marienthali Kliinik OÜ
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TallinnEstoniaRecruiting
Arstikeskus Confido AS
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TallinnEstoniaRecruiting
Tartu University Hospital
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Tartu LinnEstoniaRecruiting
Hospital Universitario Fundación Alcorcón
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AlcorcónSpainRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hestia Palau S.L.
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BarcelonaSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Ospedale San Raffaele S.r.l.
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MilanItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyRecruiting
Neurocrine Clinical Site
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Ansan-siSouth KoreaRecruiting
Neurocrine Clinical Site
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SeoulSouth KoreaRecruiting
Prywatne Gabinety Lekarskie „Promedicus” Anna Agnieszka Tomczak
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BiałystokPolandRecruiting
Ośrodek Badań Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak, Małgorzata Trzaska
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BydgoszczPolandRecruiting
Centrum Zdrowia Alcea
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GdanskPolandRecruiting
Gyncentrum Sp. z o. o.
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WarsawPolandRecruiting
Neurocrine Clinical Site
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BelgradeSerbiaRecruiting
Neurocrine Clinical Site
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KovinSerbiaRecruiting
Neurocrine Clinical Site
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KragujevacSerbiaRecruiting
Neurocrine Clinical Site
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KeelungTaiwanRecruiting
Neurocrine Clinical Site
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TaipeiTaiwanRecruiting
Neurocrine Clinical Site
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AlbuquerqueUnited StatesActive, not recruiting
Neurocrine Clinical Site
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AustinUnited StatesActive, not recruiting
Neurocrine Clinical Site
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BellaireUnited StatesRecruiting
Neurocrine Clinical Site
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CharlotteUnited StatesRecruiting
Neurocrine Clinical Site
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DraperUnited StatesRecruiting
Neurocrine Clinical Site
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EdmondUnited StatesRecruiting
Neurocrine Clinical Site
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FriendswoodUnited StatesTerminated
Neurocrine Clinical Site
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Glen OaksUnited StatesRecruiting
Neurocrine Clinical Site
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Iowa CityUnited StatesRecruiting
Neurocrine Clinical Site
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MarreroUnited StatesRecruiting
Neurocrine Clinical Site
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Miami GardensUnited StatesRecruiting
Neurocrine Clinical Site
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New HavenUnited StatesRecruiting
Neurocrine Clinical Site
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OceansideUnited StatesRecruiting
Neurocrine Clinical Site
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O'FallonUnited StatesRecruiting
Neurocrine Clinical Site
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Oklahoma CityUnited StatesRecruiting
Neurocrine Clinical Site
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OrangeUnited StatesRecruiting
Neurocrine Clinical Site
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OrlandoUnited StatesRecruiting
Neurocrine Clinical Site
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Palm BayUnited StatesRecruiting
Neurocrine Clinical Site
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PhiladelphiaUnited StatesRecruiting
Neurocrine Clinical Site
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RoanokeUnited StatesRecruiting
Neurocrine Clinical Site
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San JoseUnited StatesRecruiting
Neurocrine Clinical Site
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StaffordUnited StatesRecruiting
Neurocrine Clinical Site
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TampaUnited StatesRecruiting
Neurocrine Clinical Site
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Wichita FallsUnited StatesActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.