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Taking people in United StatesPhase 3

Long-term safety study of NBI-1065845 added to treatment for depression

Tests NBI-1065845 as an added treatment in adults with major depressive disorder.

Key facts

Who runs it
Neurocrine Biosciences
Where
Atlanta, Avon Lake, Bellaire, Boston, Bryant, Cedarhurst, Chino, Cromwell, Dallas, DeSoto, Draper, Edmond, Farmington, Gaithersburg, Glendale, Hollywood, Houston, Huntsville, Irvine, Little Rock, Los Angeles, Maitland, Miami, Miami Gardens, Mount Kisco, New York, O'Fallon, Oceanside, Oklahoma City, Orange, Orlando, Palm Bay, Philadelphia, Pico Rivera, Richmond, Saint Charles, San Diego, San Francisco, San Jose, Stafford, Tampa, The Bronx, The Woodlands, Upland, and Watertown, United StatesSee the 45 sitesAlso in 22 other countries, 92 sites
Registry title
Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Status
Recruiting
Phase
Phase 3
People taking part
850 people, planned
Started
16 Apr 2025
Expected to end
May 2030
Type of study
Interventional
Treatments tested
  • NBI-1065845
Record updated
2 November 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 recurrent moderate or severe major depression, or persistent depressive disorder, whose depression has not improved enough on oral antidepressants.

Age
18 years or older
Sex
All sexes can join
Disease stage
Recurrent major depressive disorder (moderate or severe) or persistent depressive disorder
Earlier treatment
Inadequate response to oral antidepressants in the current episode; must have taken oral antidepressants for at least 8 weeks before screening

Main reasons for not taking part

  • Another psychiatric disorder in the last 1 year that was the main focus of treatment
  • Considered by the investigator to be at imminent risk of suicide or injury to self or others

The registry criteria, word for word

Show all 6 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 prior to screening
  • 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
  • Are considered by the investigator to be at imminent risk of suicide or injury to self or others; Other protocol defined inclusion and exclusion criteria apply

Where in United States

Also in 22 other countries, 92 sites

  • Atlanta, GeorgiaHospital not named in the registryTaking people
  • Avon Lake, OhioHospital not named in the registryTaking people
  • Bellaire, TexasHospital not named in the registryNo longer taking part
  • Boston, MassachusettsHospital not named in the registryTaking people
  • Bryant, ArkansasHospital not named in the registryTaking people
  • Cedarhurst, New YorkHospital not named in the registryTaking people
  • Chino, CaliforniaHospital not named in the registryTaking people
  • Cromwell, ConnecticutHospital not named in the registryTaking people
  • Dallas, TexasHospital not named in the registryTaking people
  • DeSoto, TexasHospital not named in the registryTaking people
  • Draper, UtahHospital not named in the registryTaking people
  • Edmond, OklahomaHospital not named in the registryTaking people
  • Farmington, ConnecticutHospital not named in the registryTaking people
  • Gaithersburg, MarylandHospital not named in the registryTaking people
  • Glendale, CaliforniaHospital not named in the registryTaking people
  • Hollywood, FloridaHospital not named in the registryTaking people
  • Houston, TexasHospital not named in the registryTaking people
  • Huntsville, AlabamaHospital not named in the registryTaking people
  • Irvine, CaliforniaHospital not named in the registryTaking people
  • Little Rock, ArkansasHospital not named in the registryTaking people
  • Los Angeles, CaliforniaHospital not named in the registryTaking people
  • Maitland, FloridaHospital not named in the registryTaking people
  • Miami, FloridaHospital not named in the registryTaking people
  • Miami Gardens, FloridaHospital not named in the registryTaking people
  • Mount Kisco, New YorkHospital not named in the registryTaking people
  • New YorkHospital not named in the registryTaking people
  • O'Fallon, MissouriHospital not named in the registryTaking people
  • Oceanside, CaliforniaHospital not named in the registryTaking people
  • Oklahoma City, OklahomaHospital not named in the registryNo longer taking part
  • Orange, CaliforniaHospital not named in the registryTaking people
  • Orlando, FloridaHospital not named in the registryNo longer taking part
  • Palm Bay, FloridaHospital not named in the registryTaking people
  • Philadelphia, PennsylvaniaHospital not named in the registryTaking people
  • Pico Rivera, CaliforniaHospital not named in the registryTaking people
  • Richmond, TexasHospital not named in the registryNo longer taking part
  • Saint Charles, MissouriHospital not named in the registryTaking people
  • San Diego, CaliforniaHospital not named in the registryTaking people
  • San Francisco, CaliforniaHospital not named in the registryNo longer taking part
  • San Jose, CaliforniaHospital not named in the registryTaking people
  • Stafford, TexasHospital not named in the registryTaking people
  • Tampa, FloridaHospital not named in the registryTaking people
  • The Bronx, New YorkHospital not named in the registryTaking people
  • The Woodlands, TexasHospital not named in the registryTaking people
  • Upland, CaliforniaHospital not named in the registryNo longer taking part
  • Watertown, MassachusettsHospital not named in the registryTaking people

About the trial

What the trial wants to find out

This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.

The group in the trial

  • NBI-1065845Treatment being tested

    NBI-1065845 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 Long-Term, Open-Label Study to Assess the Safety and Tolerability of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)
Plain-language title
Long-term safety study of NBI-1065845 added to treatment for depressionGenerated 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
2 November 2026