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."}
• {"criterion_text":"-2.≥18 years of age at the time of signing the informed consent."}
• {"criterion_text":"-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."}
• {"criterion_text":"-5. The subject must be receiving oral antidepressant treatment(s) as defined in the protocol."}
• {"criterion_text":"-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)."}
• {"criterion_text":"-7.Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1)."}
• {"criterion_text":"-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."}
• {"criterion_text":"-2. Are considered by the investigator to be at imminent risk of suicide or injury to self or others."}
• {"criterion_text":"-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."}
• {"criterion_text":"-9.Pregnant (ie, positive pregnancy test at screening or baseline), lactating, or plans to become pregnant during the study."}
• {"criterion_text":"-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."}
• {"criterion_text":"-11.Any laboratory abnormality suggestive of clinically significant, poorly or unmanaged, undiagnosed disease."}
• {"criterion_text":"-12.History of epilepsy, seizures, or convulsions."}
• {"criterion_text":"-13.History of neurological abnormalities including brain injury (including traumatic injury), perinatal cerebropathy, and postnatal brain damage, blood-brain barrier abnormality, and cavernous angioma."}
• {"criterion_text":"-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 time from randomization to relapse.","definition_or_measurement_approach":"Measured as time from randomization to relapse (time-to-event endpoint)."}

Methods

• Country-specific recruitment arrangements documents (K1) and recruitment brochures (K2) are provided for multiple countries (Poland, Bulgaria, Spain, Estonia, Italy).
• Digital participant engagement via 'Mural Link' participant app and associated digital materials (Spain: Mural Link Participant App, Terms and Conditions, Privacy Policy).
• Direct-to-Patient investigational product (IP) delivery (Marken LLP listed with duty 'Direct to Patient IP delivery').
• Use of recruitment brochures and participant-facing printed/electronic materials (country-specific).

Poland

Earliest CTIS Part Ii Submission Date

28-08-2025

Latest Decision Or Authorization Date

06-05-2026

Processing Time Days

251

Number Of Sites

4

Number Of Participants

33

Bulgaria

Earliest CTIS Part Ii Submission Date

28-08-2025

Latest Decision Or Authorization Date

07-05-2026

Processing Time Days

252

Number Of Sites

4

Number Of Participants

45

Spain

Earliest CTIS Part Ii Submission Date

17-06-2025

Latest Decision Or Authorization Date

08-05-2026

Processing Time Days

325

Number Of Sites

4

Number Of Participants

27

Estonia

Earliest CTIS Part Ii Submission Date

02-09-2025

Latest Decision Or Authorization Date

08-05-2026

Processing Time Days

248

Number Of Sites

3

Number Of Participants

28

Italy

Earliest CTIS Part Ii Submission Date

17-06-2025

Latest Decision Or Authorization Date

04-05-2026

Processing Time Days

321

Number Of Sites

3

Number Of Participants

25

Primary sponsor

Full Name

Neurocrine Biosciences Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Ppd Inc.

Responsibilities

PK analysis

Name

IQVIA Limited

Responsibilities

Clinical trial services including Cardiac Services & supplying ECG machines and other listed duties

Name

Marken LLP

Responsibilities

Direct to Patient IP delivery

Name

Medidata Solutions Inc.

Responsibilities

Electronic data/eCOA support (listed duty code 7)

Name

Eresearchtechnology Inc.

Responsibilities

Electronic data support (listed duty code 7)

Name

Iqvia Laboratories Limited

Responsibilities

Laboratory services (listed duty code 4)

Name

Signant Health Global LLC

Responsibilities

Electronic patient data capture/provider (listed duty code 3)

Third parties

• {"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":"Signant Health Global LLC","duties_or_roles":"3","organisation_type":"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":"Ppd Inc.","duties_or_roles":"PK analysis","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"Adjudication Committee","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Cardiac Services & supplying ECG machines; other clinical trial services (codes 1,2,5,12,15)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Marken LLP","duties_or_roles":"Direct to Patient IP delivery","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"7","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"4","organisation_type":"Non-Pharmaceutical company"}