AMPA NOVA-3
Research type
Research Study
Full 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)
IRAS ID
1012211
Contact name
Amanda Richter
Contact email
Sponsor organisation
Neurocrine Biosciences, Inc.
Clinicaltrials.gov Identifier
Research summary
Depression is one of the most common mental health conditions, affecting up to 17% of people over their lifetime. Many people with major depressive disorder (MDD) do not experience adequate relief from standard antidepressant medications.
This study is being conducted to test an investigational drug, NBI-1065845, and whether it is safe and effective when taken orally once daily alongside current antidepressants in people with MDD who have not responded well to other antidepressants.
About 200 people aged 18 and older with moderate or severe depression will take part in the study at approximately 50 study centres in the United States, the United Kingdom and Europe.
All participants will continue their current antidepressant and will be randomly assigned to receive either NBI-1065845 or a placebo (a pill with no active drug) for 8 weeks. Neither the participants nor the study doctors will know which treatment participants are receiving.
The study consists of up to 8 study visits divided into 3 parts as follows:
• Screening Period – lasts up to 4 weeks
• Study treatment – lasts 8 weeks
• Follow-Up Period – 2 weeks after treatmentAfter completing the 8-week treatment, participants can choose to continue into a longer-term safety study with the active drug.
Participants will be monitored closely for changes in their depression symptoms and any side effects.
Information learned from this study may help other people with depression in the future.
REC name
London - City & East Research Ethics Committee
REC reference
25/LO/0522
Date of REC Opinion
31 Jul 2025
REC opinion
Further Information Favourable Opinion