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RecruitingNCT06963021

NBI-1065845 added to care for major depression

About this titleRead the official source — NCT06963021

This study evaluates the safety and effectiveness of NBI-1065845 for people with depression.

Medication studyAges 18+Multiple countries
The study in practice

Understand this study

What is this study about?

This study evaluates the safety and effectiveness of NBI-1065845 for people with depression.

Who could participate?

This study is for people with depression. Listed age limits: from 18 years. Other eligibility criteria apply.

What will I do during this study?

You are randomly assigned to receive NBI-1065845 or a matching placebo (an inactive comparison treatment) by mouth once a day, alongside your current treatment. The main symptom measure is assessed through day 56. The registry does not specify the visit schedule in the information reviewed here.

Listed locations
Chino and 34 more locationsSee all locations and recruitment
Study phase
Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.

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What to know before participating

A point to clarify

This summary does not cover all risks or eligibility requirements. What risks or changes to my care would apply to me?

Study clarity

Things to check before joining

Study start dateStarted: May 30, 2025
Recruitment status
Recruiting
Enrollment listed in the registry
200
Sponsor
Neurocrine Biosciences
Sponsor type
Biotech company
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
Locations
United States, Canada, United Kingdom, ...
Age range
Over 18 Years
Official registry ID
NCT06963021
Official title
Show the full official title

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)

Recruitment & locations

Currently recruiting

Chino, United States · Los Angeles, United States · Stanford, United States

29 more locations
  • Aurora, United States
  • Cromwell, United States
  • Farmington, United States
  • Maitland, United States
  • Miami, United States
  • Tampa, United States
  • Gaithersburg, United States
  • Cedarhurst, United States
  • New York, United States
  • Charlotte, United States
  • Philadelphia, United States
  • Alken, Belgium
  • Bruges, Belgium
  • Mechelen, Belgium
  • Toronto, Canada
  • Verdun, Canada
  • Kuopio, Finland
  • Oulu, Finland
  • Tampere, Finland
  • Budapest, Hungary
  • Gyöngyös, Hungary
  • Kalocsa, Hungary
  • Jelgava, Latvia
  • Liepāja, Latvia
  • Sigulda, Latvia
  • London, United Kingdom
  • Salford, United Kingdom
  • Sheffield, United Kingdom
  • Southampton, United Kingdom

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FAQ

Questions about this study

What is this study about?

This study evaluates the safety and effectiveness of NBI-1065845 for people with depression.

Who is behind this study?

The study sponsor is Neurocrine Biosciences, a biotech company.

Does this study involve medication?

Yes. The study involves medication, including NBI-1065845 and Placebo.

Who can participate?

This study is for people with depression. Listed age limits: from 18 years. Other eligibility criteria apply.

Is this study still recruiting?

The registry lists this study as recruiting.

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