Skip to content
Bored Studies
RecruitingPhase 3

Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

Neurocrine Biosciences · NCT06966401

View Study & Apply (opens in a new tab)

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
850
US sites recruiting
42
Study start
April 16, 2025
Record last updated
July 24, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: NBI-1065845

Conditions: Major Depressive Disorder

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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 prior to screening.
  • 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.

Other protocol defined inclusion and exclusion criteria apply.

Recruiting US locations

Study contacts (from the official record)

  • Neurocrine Medical Information Call Center · 1-877-641-3461 · medinfo@neurocrine.com
All mental health studies in Alabama →
Long-Term Study to Assess the Safety and Tolerability of… (NCT06966401) | Bored Studies