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

ClinicalTrials.gov ID NCT07196501 · 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)

Check if you may qualify View the official record

At a glance

Status
Recruiting
Condition
Major Depressive Disorder
Phase
Phase 3
Ages
18 Years to no maximum
Sex
All
Healthy volunteers
Not accepted
What is being studied
NBI-1065845 (drug); Placebo (drug)
Sponsor
Neurocrine Biosciences
Target enrollment
550 participants
Study sites
57 open in Alberta, British Columbia, Bulgaria, California, Canada, Connecticut, Estonia, Florida, Gyeonggi-do, Iowa, Italy, Louisiana, Madrid, Missouri, New Mexico, New York, North Carolina, Oklahoma, Ontario, Pennsylvania, Poland, Quebec, Serbia, South Korea, Spain, Taiwan, Texas, Utah, Victoria, Virginia
Start date
2025-08-18
Primary completion
2028-07

Common questions

Is NCT07196501 still recruiting?

ClinicalTrials.gov lists this trial as recruiting (checked 5 October 2026). It has 57 open or upcoming sites.

Who can take part in NCT07196501?

The record lists people aged 18 years to no upper limit with major depressive disorder. The study team decides who is eligible, and the full criteria are on this page and in the official record.

Where is NCT07196501 running?

57 sites in Alberta, British Columbia, Bulgaria, California, Canada, Connecticut, Estonia, Florida, Gyeonggi-do, Iowa, Italy, Louisiana, Madrid, Missouri, New Mexico, New York, North Carolina, Oklahoma, Ontario, Pennsylvania, Poland, Quebec, Serbia, South Korea, Spain, Taiwan, Texas, Utah, Victoria, Virginia, according to ClinicalTrials.gov.

What is being studied in NCT07196501?

It is a Phase 3 trial. The record lists these interventions: NBI-1065845 and Placebo. The sponsor is Neurocrine Biosciences.

How many people will NCT07196501 enroll?

The record gives a target of 550 participants.

How do I sign up for NCT07196501?

Use "Check if you may qualify" on this page to answer a few screening questions, or contact the study team listed on ClinicalTrials.gov.

About this trial

From the ClinicalTrials.gov record.

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.

Where it's running

SiteCityStateStatus
Neurocrine Clinical SiteOceansideCaliforniaRecruiting
Neurocrine Clinical SiteOrangeCaliforniaRecruiting
Neurocrine Clinical SiteSan JoseCaliforniaRecruiting
Neurocrine Clinical SiteNew HavenConnecticutRecruiting
Neurocrine Clinical SiteMiami GardensFloridaRecruiting
Neurocrine Clinical SiteOrlandoFloridaRecruiting
Neurocrine Clinical SitePalm BayFloridaRecruiting
Neurocrine Clinical SiteTampaFloridaRecruiting
Neurocrine Clinical SiteIowa CityIowaRecruiting
Neurocrine Clinical SiteMarreroLouisianaRecruiting
Neurocrine Clinical SiteO'FallonMissouriRecruiting
Neurocrine Clinical SiteAlbuquerqueNew MexicoRecruiting
Neurocrine Clinical SiteGlen OaksNew YorkRecruiting
Neurocrine Clinical SiteCharlotteNorth CarolinaRecruiting
Neurocrine Clinical SiteEdmondOklahomaRecruiting
Neurocrine Clinical SiteOklahoma CityOklahomaRecruiting
Neurocrine Clinical SitePhiladelphiaPennsylvaniaRecruiting
Neurocrine Clinical SiteBellaireTexasRecruiting
Neurocrine Clinical SiteStaffordTexasRecruiting
Neurocrine Clinical SiteWichita FallsTexasRecruiting
Neurocrine Clinical SiteDraperUtahRecruiting
Neurocrine Clinical SiteRoanokeVirginiaRecruiting
Neurocrine Clinical SiteCarltonVictoriaRecruiting
Neurocrine Clinical SiteMelbourneVictoriaRecruiting
Neurocrine Clinical SiteParkvilleVictoriaRecruiting
Neurocrine Clinical SiteSofiaBulgariaRecruiting
Neurocrine Clinical SiteSofiaBulgariaRecruiting
Neurocrine Clinical SiteSofiaBulgariaRecruiting
Neurocrine Clinical SiteSofiaBulgariaRecruiting
Neurocrine Clinical SiteCalgaryAlbertaRecruiting
Neurocrine Clinical SiteNorth VancouverBritish ColumbiaRecruiting
Neurocrine Clinical SiteKingstonOntarioRecruiting
Neurocrine Clinical SiteSherbrookeQuebecRecruiting
Neurocrine Clinical SiteTorontoCanadaRecruiting
Neurocrine Clinical SiteTallinnEstoniaRecruiting
Neurocrine Clinical SiteTallinnEstoniaRecruiting
Neurocrine Clinical SiteTartuEstoniaRecruiting
Neurocrine Clinical SiteRomaItalyRecruiting
Neurocrine Clinical SiteRomeItalyRecruiting
Neurocrine Clinical SiteTorinoItalyRecruiting
Neurocrine Clinical SiteBialystokPolandRecruiting
Neurocrine Clinical SiteBydgoszczPolandRecruiting
Neurocrine Clinical SiteGdanskPolandRecruiting
Neurocrine Clinical SiteBelgradeSerbiaRecruiting
Neurocrine Clinical SiteKovinSerbiaRecruiting
Neurocrine Clinical SiteKragujevacSerbiaRecruiting
Neurocrine Clinical SiteAnsan-siGyeonggi-doRecruiting
Neurocrine Clinical SiteSeoulSouth KoreaRecruiting
Neurocrine Clinical SiteSeoulSouth KoreaRecruiting
Neurocrine Clinical SiteSeoulSouth KoreaRecruiting
Neurocrine Clinical SiteAlcorcónMadridRecruiting
Neurocrine Clinical SiteBarcelonaSpainRecruiting
Neurocrine Clinical SiteBarcelonaSpainRecruiting
Neurocrine Clinical SiteKeelungTaiwanRecruiting
Neurocrine Clinical SiteTaipeiTaiwanRecruiting
Neurocrine Clinical SiteTaipeiTaiwanRecruiting
Neurocrine Clinical SiteTaipeiTaiwanRecruiting
Full eligibility criteria (from the record)

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.

Other recruiting trials: Depression (major depressive disorder) clinical trials · Depression (major depressive disorder) clinical trials in Texas

This listing shows only what the public ClinicalTrials.gov record NCT07196501 says, last updated there on 2026-07-24. It was checked against the registry on 5 October 2026. Taking part is voluntary, and the study team decides who is eligible. For the most current details, see the official record.