Major Depressive Disorder
Conditions
Keywords
MDD, Depression, Major Depressive Disorder, NBI-1065845, TAK-653
Brief summary
This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.
Interventions
DRUGNBI-1065845
NBI-1065845 tablets
Sponsors
Neurocrine Biosciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key 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 prior to screening. * Willing and able to comply with all study procedures and restrictions in the opinion of the investigator. Key
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. Other protocol defined inclusion and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | Baseline through Week 52 |
Countries
Belgium, Bulgaria, Canada, Croatia, Czechia, Estonia, Finland, Hungary, Italy, Latvia, Lithuania, Netherlands, Poland, Romania, Slovakia, Spain, Sweden, Taiwan, United Kingdom, United States
Contacts
CONTACTNeurocrine Medical Information Call Center
STUDY_DIRECTORClinical Development Lead
Neurocrine Biosciences
Outcome results
None listed