Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NBI-1065845, Placebo.
- Who it may be relevant to
- Registry conditions: Major Depressive Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Interventions
- Drug NBI-1065845
NBI-1065845 tablets - Drug Placebo
Matching placebo tablets
Primary outcome measures
- Change from Baseline in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Day 56 [Time frame: Baseline, Day 56]
Secondary outcome measures (2)
- Change from Baseline in Sheehan Disability Scale (SDS) Total Score at Day 56 [Time frame: Baseline, Day 56]
- Change from Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Day 56 [Time frame: Baseline, Day 56]
Eligibility criteria
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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 18 centers
- Neurocrine Clinical Site — Little Rock
- Neurocrine Clinical Site — Garden Grove
- Neurocrine Clinical Site — Orange
- Neurocrine Clinical Site — Pico Rivera
- Neurocrine Clinical Site — San Diego
- Neurocrine Clinical Site — Upland
- Neurocrine Clinical Site — Hollywood
- Neurocrine Clinical Site — Maitland
- … and 10 more centers
Identifiers
NCT: NCT06786624 · NBI-1065845-MDD3024 · 2024-519418-29-00