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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)

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)

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 the long-term safety of NBI-1065845 and how well people can handle taking it along with antidepressants. It is for people with major depression that has come back or depression that lasts a long time, whose current antidepressant treatment has not helped enough.

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

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 depression that lasts a long time.
  • 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 before the screening visit.
  • 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.

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 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.

Study sites (46)

AL

AR

CA

CT

FL

GA

MA

MD

MO

NY

OH

OK

PA

TX

WA