Study to assess the efficacy and safety of adjunctive NBI-1065845 in adults with Major Depressive Disorder (MDD)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Neurocrine Biosciences Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Trial duration

28 Aug 2025 → ongoing

Decision date (initial)

2025-07-25

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Neurocrine Biosciences Inc.

External identifiers

EU CT number

2024-519421-37-00

ClinicalTrials.gov

NCT06963021

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Therapy, Safety

The primary objective for this study is to evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in subjects with MDD on improving symptoms of depression, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS).

Secondary objectives 2

1. To evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in subjects with MDD on: − Improving overall functioning (as measured by the Sheehan Disability Scale [SDS]), and − Improving the overall severity of depression (as measured by the Clinical Global Impression-Severity Scale [CGI-S]).
2. To evaluate the safety and tolerability of NBI-1065845 as an adjunctive treatment in subjects with MDD

Conditions and MedDRA coding

Major Depressive Disorder

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 1.Completed informed consent.
2. 2.≥18 years of age at the time of signing the informed consent.
3. 4.The subject has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder. The MDD diagnosis must be confirmed using the Mini-International Neuropsychiatric Interview (MINI) in a face-to-face evaluation.
4. 5.The subject must be receiving oral antidepressant treatment(s) as defined in the protocol.
5. 6.Subject must have an Inadequate Response (IR) to oral antidepressant treatments that were administered as adequate courses (dose, duration, adherence) in the current episode of depression, as assessed using the Massachusetts General Hospital - Antidepressant Treatment Response Questionnaire (MGH-ATRQ).
6. 7.Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1).
7. 13. Willing and able to comply with all study procedures and restrictions in the opinion of the investigator.

Exclusion criteria 9

1. 1.A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD (assessed by the MINI); a comorbid personality disorder that has been evident outside of depressive episodes or that may interfere with participation in the study; or a diagnosis of neurodegenerative disorder (including but not limited to dementia), eating disorder (except binge eating disorder), schizophrenia, schizoaffective disorder, bipolar disorder, MDD with psychotic features or mixed features, intellectual disability, or mental disorder due to a general medical condition as defined in DSM-5.
2. 2.Are considered by the investigator to be at imminent risk of suicide or injury to self or others.
3. 6.The subject’s depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy (ECT) in the current major depressive episode, defined as at least 7 treatments with unilateral/bilateral ECT.
4. 9.Pregnant (ie, positive pregnancy test at screening or baseline) or lactating or plans to become pregnant during the study.
5. 10.An unstable medical condition or unstable chronic disease (including history of neurological [including cognitive impairment, myasthenia gravis], hepatic, renal, cardiovascular, gastrointestinal, pulmonary, autoimmune, or endocrine disease that may affect study participation or results) within 3 months before Day 1, or malignancy within 6 months before Day 1.
6. 11.Any laboratory abnormality suggestive of clinically significant, poorly or unmanaged, undiagnosed disease.
7. 12.History of epilepsy, seizures, or convulsions
8. 13.History of neurological abnormalities including brain injury (including traumatic injury), perinatal cerebropathy, and postnatal brain damage, blood- brain barrier abnormality, and cavernous angioma.
9. 20. Any reason that makes the subject unsuitable for participation in this study (eg, subject is homeless, known to have difficulty complying with treatment or medical procedures, known to provide inaccurate medical information, or known to attempt participation in clinical trials inappropriately) per the investigator, Medical Monitor, and/or Sponsor.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint for this study will be the change from baseline in total MADRS score at Day 56.

Secondary endpoints 2

1. Change from baseline in SDS total score at Day 56
2. Change from baseline in CGI-S score at Day 56

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Neurocrine Biosciences Inc.

Sponsor organisation

Neurocrine Biosciences Inc.

Address

6027 Edgewood Bend Court

City

San Diego

Postcode

92130-8235

Country

United States

Scientific contact point

Organisation

Neurocrine Biosciences Inc.

Contact name

Neurocrine Medical Information Call Center

Public contact point

Organisation

Neurocrine Biosciences Inc.

Contact name

Neurocrine Medical Information Call Center

Third parties 10

Locations

4 EU/EEA countries · 14 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 65 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications