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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06966401




Registration number
Help: Registration number
NCT06966401
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
30/04/2025
Date registered
Help: Date registered
11/05/2025
Date last updated
Help: Date last updated
2/11/2026

Titles & IDs
Public title
Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Scientific 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)
Additional trial identifiers [1] 0 0
2024-519423-24-00
Additional trial identifiers [2] 0 0
NBI-1065845-MDD3028
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Major Depressive Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Treatment: Drugs - NBI-1065845

Experimental: NBI-1065845 - NBI-1065845 administered orally once a day.


Treatment: Drugs: NBI-1065845
NBI-1065845 tablets
Intervention code [1] 0 0
Treatment: Drugs
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Baseline through Week 52

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
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 exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/04/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2030
Actual
Sample size
Target
850
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Neurocrine Clinical Site - Carlton
Recruitment hospital [2] 0 0
Neurocrine Clinical Site - Melbourne
Recruitment postcode(s) [1] 0 0
3053 - Carlton
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment outside Australia
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Alabama
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Missouri
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Belgrade
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Bojnice
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Svidník
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Keelung
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Neurocrine Biosciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Development Lead
Address 0 0
Neurocrine Biosciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Neurocrine Medical Information Call Center
Address 0 0
Country 0 0
Phone 0 0
1-877-641-3461
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06966401