Ireland
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Recruiting Phase 3

A Study to Evaluate the Maintenance Effect of Osavampator as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

NCT07196501 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2025-08-18
Last updated
2026-10-22

Condition(s) studied

Major Depressive Disorder

Investigational drug(s) / intervention(s)

Osavampator →Placebo

Osavampator: Oral tablet

Placebo: Oral tablet

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: * 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. Key Exclusion Criteria: * 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. * 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.

Primary outcome measure(s)

  • Time from Randomization to Relapse — From randomization to the earliest of relapse or end-of study (up to approximately 32 months)

Trial sites (61)

FacilityCityRegionStatus
Neurocrine Clinical Site Oceanside California Recruiting
Neurocrine Clinical Site Orange California Recruiting
Neurocrine Clinical Site San Jose California Recruiting
Neurocrine Clinical Site New Haven Connecticut Recruiting
Neurocrine Clinical Site Miami Gardens Florida Recruiting
Neurocrine Clinical Site Orlando Florida Recruiting
Neurocrine Clinical Site Palm Bay Florida Recruiting
Neurocrine Clinical Site Tampa Florida Recruiting
Neurocrine Clinical Site Iowa City Iowa Recruiting
Neurocrine Clinical Site Marrero Louisiana Recruiting
Neurocrine Clinical Site O'Fallon Missouri Recruiting
Neurocrine Clinical Site Albuquerque New Mexico Active Not Recruiting
Neurocrine Clinical Site Glen Oaks New York Recruiting
Neurocrine Clinical Site Charlotte North Carolina Recruiting
Neurocrine Clinical Site Edmond Oklahoma Recruiting
Neurocrine Clinical Site Oklahoma City Oklahoma Recruiting
Neurocrine Clinical Site Philadelphia Pennsylvania Recruiting
Neurocrine Clinical Site Austin Texas Active Not Recruiting
Neurocrine Clinical Site Bellaire Texas Recruiting
Neurocrine Clinical Site Friendswood Texas Terminated
Neurocrine Clinical Site Stafford Texas Recruiting
Neurocrine Clinical Site Wichita Falls Texas Active Not Recruiting
Neurocrine Clinical Site Draper Utah Recruiting
Neurocrine Clinical Site Roanoke Virginia Recruiting
Neurocrine Clinical Site Carlton Victoria Recruiting
Neurocrine Clinical Site Melbourne Victoria Recruiting
Neurocrine Clinical Site Parkville Victoria Recruiting
Neurocrine Clinical Site Sofia Bulgaria Recruiting
Neurocrine Clinical Site Sofia Bulgaria Recruiting
Neurocrine Clinical Site Sofia Bulgaria Recruiting
Neurocrine Clinical Site Sofia Bulgaria Recruiting
Neurocrine Clinical Site Calgary Alberta Recruiting
Neurocrine Clinical Site North Vancouver British Columbia Recruiting
Neurocrine Clinical Site Kingston Ontario Recruiting
Neurocrine Clinical Site Sherbrooke Quebec Active Not Recruiting
Neurocrine Clinical Site Toronto Canada Recruiting
Neurocrine Clinical Site Tallinn Estonia Recruiting
Neurocrine Clinical Site Tallinn Estonia Recruiting
Neurocrine Clinical Site Tartu Estonia Recruiting
Neurocrine Clinical Site Milan Italy Withdrawn

+ 21 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07196501 on ClinicalTrials.gov ↗ ← All trials in the USA