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Recruiting NCT07196501

A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

Phase III Interventional Major Depressive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NBI-1065845, Placebo.
Who it may be relevant to
Registry conditions: Major Depressive Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Bulgaria, Canada, Estonia +6
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

The primary objective of this study is to evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in delaying relapse of depressive symptoms (maintenance of effect) in participants with MDD.

Interventions

  • Drug NBI-1065845
    Oral tablet
  • Drug Placebo
    Oral tablet

Primary outcome measures

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

Eligibility criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 24 centers
  • Neurocrine Clinical Site — Oceanside
  • Neurocrine Clinical Site — Orange
  • Neurocrine Clinical Site — San Jose
  • Neurocrine Clinical Site — New Haven
  • Neurocrine Clinical Site — Miami Gardens
  • Neurocrine Clinical Site — Orlando
  • Neurocrine Clinical Site — Palm Bay
  • Neurocrine Clinical Site — Tampa
  • … and 16 more centers
Canada · 5 centers
  • Neurocrine Clinical Site — Calgary
  • Neurocrine Clinical Site — North Vancouver
  • Neurocrine Clinical Site — Kingston
  • Neurocrine Clinical Site — Sherbrooke
  • Neurocrine Clinical Site — Toronto
Bulgaria · 4 centers
  • Neurocrine Clinical Site — Sofia
  • Neurocrine Clinical Site — Sofia
  • Neurocrine Clinical Site — Sofia
  • Neurocrine Clinical Site — Sofia
Italy · 4 centers
  • Neurocrine Clinical Site — Milan
  • Neurocrine Clinical Site — Roma
  • Neurocrine Clinical Site — Rome
  • Neurocrine Clinical Site — Torino
South Korea · 4 centers
  • Neurocrine Clinical Site — Ansan-si
  • Neurocrine Clinical Site — Seoul
  • Neurocrine Clinical Site — Seoul
  • Neurocrine Clinical Site — Seoul
Taiwan · 4 centers
  • Neurocrine Clinical Site — Keelung
  • Neurocrine Clinical Site — Taipei
  • Neurocrine Clinical Site — Taipei
  • Neurocrine Clinical Site — Taipei
Australia · 3 centers
  • Neurocrine Clinical Site — Carlton
  • Neurocrine Clinical Site — Melbourne
  • Neurocrine Clinical Site — Parkville
Estonia · 3 centers
  • Neurocrine Clinical Site — Tallinn
  • Neurocrine Clinical Site — Tallinn
  • Neurocrine Clinical Site — Tartu
Poland · 3 centers
  • Neurocrine Clinical Site — Bialystok
  • Neurocrine Clinical Site — Bydgoszcz
  • Neurocrine Clinical Site — Gdansk
Serbia · 3 centers
  • Neurocrine Clinical Site — Belgrade
  • Neurocrine Clinical Site — Kovin
  • Neurocrine Clinical Site — Kragujevac
Spain · 3 centers
  • Neurocrine Clinical Site — Alcorcón
  • Neurocrine Clinical Site — Barcelona
  • Neurocrine Clinical Site — Barcelona

Identifiers

NCT: NCT07196501 · NBI-1065845-MDD3027 · 2025-520541-72-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗