9-(4-CYCLOHEXYLOXYPHENYL)-7-METHYL-3,4-DIHYDROPYRAZINO[2,1-C][1,2,4]THIADIAZINE 2,2-DIOXIDE for Major Depressive Disorder

Inclusion criteria

• {"criterion_text":"- 1.Completed informed consent.\n- 2.≥18 years of age at the time of signing the informed consent.\n- 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\n- 5.The subject must be receiving oral antidepressant treatment(s) as defined in the protocol.\n- 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).\n- 7.Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1).\n- 13. Willing and able to comply with all study procedures and restrictions in the opinion of the investigator."}

Exclusion criteria

• {"criterion_text":"- 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.\n- 2.Are considered by the investigator to be at imminent risk of suicide or injury to self or others.\n- 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.\n- 9.Pregnant (ie, positive pregnancy test at screening or baseline) or lactating or plans to become pregnant during the study.\n- 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.\n- 11.Any laboratory abnormality suggestive of clinically significant, poorly or unmanaged, undiagnosed disease.\n- 12.History of epilepsy, seizures, or convulsions\n- 13.History of neurological abnormalities including brain injury (including traumatic injury), perinatal cerebropathy, and postnatal brain damage, blood- brain barrier abnormality, and cavernous angioma.\n- 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."}

Primary endpoints

• {"endpoint_text":"- The primary endpoint for this study will be the change from baseline in total MADRS score at Day 56.","definition_or_measurement_approach":"Change from baseline in total Montgomery-Asberg Depression Rating Scale (MADRS) score measured at Day 56."}

Secondary endpoints

• {"endpoint_text":"- Change from baseline in SDS total score at Day 56","definition_or_measurement_approach":"Change from baseline in Sheehan Disability Scale (SDS) total score measured at Day 56."}
• {"endpoint_text":"- Change from baseline in CGI-S score at Day 56","definition_or_measurement_approach":"Change from baseline in Clinical Global Impression-Severity (CGI-S) score measured at Day 56."}

Methods

• Use of Recruitment arrangements and recruitment brochures (documents titled K1_Recruitment arrangements and K2_Recruitment Brochure) targeted to potential patient participants; materials are localized (English, Bulgarian, Lithuanian, Romanian, Slovak as evidenced by document titles).
• Use of participant-facing materials and informed consent forms (multiple L1_SIS and ICF documents in EN, RO, LT, BG, SK) provided to potential participants during recruitment and consent.
• Use of digital participant tools in some Member States: Mural Link Participant App materials (participant app notifications, reference guide, Participant Training) included in documents for Slovakia (titles include Mural Link Participant App, Mural Link Participant Reference Guide, Notifications for Mural Link).
• Direct-to-patient activities supported by third party Marken LLP (documented sponsor duty: 'Direct to Patient IP delivery') which may facilitate remote participation logistics.

Romania

Earliest CTIS Part Ii Submission Date

27-06-2025

Latest Decision Or Authorization Date

23-02-2026

Processing Time Days

241

Number Of Sites

4

Number Of Participants

21

Lithuania

Earliest CTIS Part Ii Submission Date

27-06-2025

Latest Decision Or Authorization Date

06-05-2026

Processing Time Days

313

Number Of Sites

5

Number Of Participants

22

Slovakia

Earliest CTIS Part Ii Submission Date

27-06-2025

Latest Decision Or Authorization Date

11-05-2026

Processing Time Days

318

Number Of Sites

9

Number Of Participants

21

Bulgaria

Earliest CTIS Part Ii Submission Date

27-06-2025

Latest Decision Or Authorization Date

08-05-2026

Processing Time Days

315

Number Of Sites

7

Number Of Participants

29

Primary sponsor

Full Name

Neurocrine Biosciences Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

IQVIA Limited

Responsibilities

Multiple operational roles including cardiac services & supplying ECG machines and other trial support (sponsorDuties codes listed).

Name

Iqvia Laboratories Limited

Name

Ppd Inc.

Responsibilities

PK analysis

Name

Medidata Solutions Inc.

Name

Cytel Inc.

Responsibilities

Adjudication Committee

Name

Signant Health Global LLC

Third parties

• {"country":"United States","full_name":"Marken LLP","duties_or_roles":"Direct to Patient IP delivery","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Massachusetts General Hospital","duties_or_roles":"participant quality assurance","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Epilepsy Study Consortium Inc.","duties_or_roles":"Adjudication Committee","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"Adjudication Committee","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Cardiac Services & supplying ECG machines; other listed duties (codes present)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Ppd Inc.","duties_or_roles":"PK analysis","organisation_type":"Pharmaceutical company"}