Tests osavampator to help keep depression from returning in adults
Tests osavampator alongside usual treatment in adults with major depressive disorder.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Maintenance Effect of Osavampator as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Key facts
- Where
- Białystok, Bydgoszcz, Gdansk, and Warsaw, PolandSee the 4 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with major depressive disorder who have not improved enough on oral antidepressants. It tests osavampator added to their current medicine.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Recurrent major depressive disorder (moderate or severe) or persistent depressive disorder, with a HAM-D17 score of 22 or higher at screening and on Day 1
- Earlier treatment
- Must have taken oral antidepressants for at least 8 weeks, with an inadequate response in the current episode, and be willing to keep the same antidepressants at the same dose
Main reasons for not taking part
- Another psychiatric disorder in the last 1 year that was the main focus of treatment
- Judged by the investigator to be at imminent risk of suicide or of harming self or others
- No response to electroconvulsive therapy (ECT) in the current depressive episode
Read by machine on 9 November 2026.
Where in Poland
- Prywatne Gabinety Lekarskie „Promedicus” Anna Agnieszka TomczakBiałystok, PolandTaking people
- Ośrodek Badań Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak, Małgorzata TrzaskaBydgoszcz, PolandTaking people
- Centrum Zdrowia AlceaGdansk, PolandTaking people
- Gyncentrum Sp. z o. o.Warsaw, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Neurocrine Biosciences
- Trial code
- NCT07196501EU 2025-520541-72-00
- Record updated
- 22 October 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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.
Exclusion: 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; Are considered by the investigator to be at imminent risk of suicide or injury to self or others.