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RecruitingPhase 3

NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether NBI-1065845, added to an antidepressant, improves depression symptoms compared with a placebo (a treatment with no active drug). It also checks safety. It is for people with depression whose current antidepressant treatment has not helped enough.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Your main diagnosis is moderate or severe major depression that has come back, or persistent depressive disorder (long-lasting depression).
  • Antidepressants taken by mouth have not helped enough during your current period of depression.
  • You have taken antidepressants by mouth for at least 8 weeks and agree to keep taking the same medicines, at the same doses and on the same schedule, during the study.
  • Your score on the HAM-D17 depression rating scale is at least 22 at screening and on Day 1.
  • The study doctor believes you are willing and able to follow all study steps and rules.

Who can't join

  • In the past year, a mental health condition other than major depression was the main focus of your treatment.
  • The study doctor believes you are at immediate risk of suicide or of harming yourself or others.
  • During your current period of major depression, your symptoms did not improve with electroconvulsive therapy (ECT), a treatment that uses electrical stimulation of the brain.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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 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.

Study sites (17)

AL

AR

CA

FL

GA

MA

MO

NY

OH

TX

VA