AMPA Vega-2
Research type
Research Study
Full 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)
IRAS ID
1012144
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 assess 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 600 people aged 18 and older with moderate or severe depression will take part in the study at approximately 200 study centres in the United States, the United Kingdom, Australia, Canada, South Korea, Serbia, Taiwan and Europe.
All participants will continue their current antidepressant and each participant will take one dose of NBI-1065845 daily through the entire study.
The study consists of up to 42 study visits divided into 3 parts as follows:
• Screening Period – lasts up to 4 weeks
• Open Label Extension Period – lasting 156 weeks (3 years)
• End of Study/Follow-Up Period – 2 weeks after treatmentParticipants 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
East Midlands - Leicester South Research Ethics Committee
REC reference
25/EM/0167
Date of REC Opinion
26 Aug 2025
REC opinion
Further Information Favourable Opinion