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Taking people in BelgiumPhase 3

Tests NBI-1065845 as an add-on treatment for major depressive disorder

Compares NBI-1065845 with placebo in adults with major depressive disorder.

Key facts

Who runs it
Neurocrine Biosciences
Where
Alken, Brugge, and Mechelen, BelgiumSee the 3 sitesAlso in 6 other countries, 31 sites
Registry title
NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Status
Recruiting
Phase
Phase 3
People taking part
200 people, planned
Started
30 May 2025
Expected to end
Jul 2027
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • NBI-1065845
  • Placebo
Record updated
10 August 2026

Who can take part

AI summary

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 moderate or severe recurrent major depression, or persistent depressive disorder, who did not respond well enough to their antidepressant. NBI-1065845 or placebo is added to it.

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
Inadequate response to oral antidepressants in the current episode. Must have taken oral antidepressants for at least 8 weeks and keep the same dose and frequency during the study.

Main reasons for not taking part

  • Another psychiatric disorder, other than MDD, that was the main focus of treatment in the last 1 year
  • Judged by the investigator to be at imminent risk of suicide or injury to self or others
  • Depression that did not respond to electroconvulsive therapy (ECT) in the current episode

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Are considered by the investigator to be at imminent risk of suicide or injury to self or others

Where in Belgium

Also in 6 other countries, 31 sites

  • AnimaAlken, BelgiumTaking people
  • Az Sint-LucasBrugge, BelgiumTaking people
  • MeclinasMechelen, BelgiumTaking people

About the trial

What the trial wants to find out

The study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression.

The 2 groups in the trial

  • NBI-1065845Treatment being tested

    NBI-1065845 administered orally once a day.

  • PlaceboPlacebo, for comparison

    Placebo identical in appearance to NBI-1065845 will be administered orally once a day.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)
Plain-language title
Tests NBI-1065845 as an add-on treatment for major depressive disorderGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
10 August 2026