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

a study on Depression

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Andrew Krystal (ucsf)
Headshot of Andrew Krystal
Andrew Krystal

Description

Summary

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

Official Title

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)

Keywords

Major Depressive Disorder, MDD, Depression, NBI-1065845, TAK-653

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Neurocrine Clinical Site accepting new patients
    Los Angeles California 90025 United States
  • Neurocrine Clinical Site accepting new patients
    San Francisco California 94107 United States
  • Neurocrine Clinical Site accepting new patients
    San Diego California 92103-8229 United States
  • Neurocrine Clinical Site accepting new patients
    Orange California 92866 United States
  • Neurocrine Clinical Site accepting new patients
    Glendale California 91206 United States
  • Neurocrine Clinical Site accepting new patients
    Pico Rivera California 90660 United States
  • Neurocrine Clinical Site accepting new patients
    Oceanside California 92056 United States

Lead Scientist at University of California Health

  • Andrew Krystal (ucsf)
    Dr. Krystal is the Ray and Dagmar Dolby Distinguished Professor in the Departments of Psychiatry and Neurology, Vice-Chair for Research in the Department of Psychiatry, Director of the Dolby Family Center for Mood Disorders, Director of the UCSF Interventional Psychiatry Program and Director of the Clinical and Translational Sleep Research Laboratory.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Neurocrine Biosciences
ID
NCT06966401
Phase
Phase 3 Depression Research Study
Study Type
Interventional
Participants
Expecting 850 study participants
Last Updated
Contact us about this trial