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)
Status: Recruiting
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
Neurocrine Clinical Site
RECRUITING
Chino
Neurocrine Clinical Site
RECRUITING
Los Angeles
Neurocrine Clinical Site
RECRUITING
Stanford
Colorado
Neurocrine Clinical Site
RECRUITING
Aurora
Connecticut
Neurocrine Clinical Site
ACTIVE_NOT_RECRUITING
Cromwell
Neurocrine Clinical Site
ACTIVE_NOT_RECRUITING
Farmington
Florida
Neurocrine Clinical Site
RECRUITING
Maitland
Neurocrine Clinical Site
RECRUITING
Miami
Neurocrine Clinical Site
WITHDRAWN
Tampa
Maryland
Neurocrine Clinical Site
ACTIVE_NOT_RECRUITING
Gaithersburg
New York
Neurocrine Clinical Site
RECRUITING
Cedarhurst
Neurocrine Clinical Site
RECRUITING
New York
Neurocrine Clinical Site
ACTIVE_NOT_RECRUITING
New York
Pennsylvania
Neurocrine Clinical Site
RECRUITING
Philadelphia
Other Locations
Belgium
Neurocrine Clinical Site
ACTIVE_NOT_RECRUITING
Alken
Neurocrine Clinical Site
RECRUITING
Bruges
Neurocrine Clinical Site
RECRUITING
Mechelen
Canada
Neurocrine Clinical Site
RECRUITING
Toronto
Finland
Neurocrine Clinical Site
RECRUITING
Kuopio
Neurocrine Clinical Site
RECRUITING
Oulu
Neurocrine Clinical Site
RECRUITING
Tampere
Hungary
Neurocrine Clinical Site
RECRUITING
Budapest
Neurocrine Clinical Site
RECRUITING
Budapest
Neurocrine Clinical Site
RECRUITING
Gyöngyös
Latvia
Neurocrine Clinical Site
RECRUITING
Jelgava
Neurocrine Clinical Site
RECRUITING
Liepāja
Neurocrine Clinical Site
RECRUITING
Sigulda
United Kingdom
Neurocrine Clinical Site
RECRUITING
Manchester
Neurocrine Clinical Site
RECRUITING
Sheffield
Neurocrine Clinical Site
RECRUITING
Southampton
Contact Information
Primary
Neurocrine Medical Information Call Center
medinfo@neurocrine.com
1-877-641-3461
Time Frame
Start Date:2025-05-30
Estimated Completion Date:2027-07
Participants
Target number of participants:200
Treatments
Experimental: NBI-1065845
NBI-1065845 administered orally once a day.
Placebo_comparator: Placebo
Placebo identical in appearance to NBI-1065845 will be administered orally once a day.