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-Åsberg Depression Rating Scale (MADRS) score at Day 56 (MADRS used to measure depressive symptoms)."}

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 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 at Day 56."}

Methods

• Recruitment brochures (K2_Recruitment Brochure) — multiple language brochures present (EN, NL, FR, HU, LV, RU) associated with country application documents (e.g., Belgium 282789, Finland 282791, Latvia 282790, Hungary 282792).
• Recruitment advertisement/flyer/poster (K2_Recruitment advertisement, K2_Recruitment flyer, K2_Recruitment poster) — files listed for Belgium and Finland (associated with application 282791 and 282789).
• Recruitment arrangements documents (K1_Recruitment arrangements) — country-specific recruitment arrangements documents present for multiple Member States (files associated with Part II entries).
• Participant-facing digital materials and app/web guides (Mural Link Participant App, Participant Mobile Web and App Screenshots, Web Patient User Guide) — supporting remote participant interaction (files associated with Hungary and other Part II applications).

Latvia

Earliest CTIS Part Ii Submission Date

30-07-2025

Latest Decision Or Authorization Date

07-05-2026

Processing Time Days

281

Number Of Sites

3

Number Of Participants

10

Belgium

Earliest CTIS Part Ii Submission Date

04-07-2025

Latest Decision Or Authorization Date

08-05-2026

Processing Time Days

308

Number Of Sites

3

Number Of Participants

14

Hungary

Earliest CTIS Part Ii Submission Date

20-06-2025

Latest Decision Or Authorization Date

12-05-2026

Processing Time Days

326

Number Of Sites

5

Number Of Participants

17

Finland

Earliest CTIS Part Ii Submission Date

07-07-2025

Latest Decision Or Authorization Date

07-05-2026

Processing Time Days

304

Number Of Sites

3

Number Of Participants

14

Primary sponsor

Full Name

Neurocrine Biosciences Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Iqvia Laboratories Limited / IQVIA Limited

Responsibilities

Clinical trial services and multiple sponsor duties (codes include 1,2,5,12,15; cardiac services & supplying ECG machines)

Name

Ppd Inc.

Responsibilities

PK analysis (sponsorDuties code 15; value: PK analysis)

Name

Medidata Solutions Inc.

Responsibilities

Data platform/support (sponsorDuties code 7 listed)

Name

Marken LLP

Responsibilities

Direct to Patient IP delivery

Third parties

• {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"sponsorDuties codes: 4 (no descriptive value provided); contact email: eu_clinical_trials_information@iqvia.com","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties code: 7 (no descriptive value provided)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Ppd Inc.","duties_or_roles":"sponsorDuties code: 15; value: PK analysis","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Marken LLP","duties_or_roles":"sponsorDuties code: 15; value: Direct to Patient IP delivery","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 1,12,15 (Cardiac Services & supplying ECG machines),2,5","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Massachusetts General Hospital","duties_or_roles":"sponsorDuties code: 15; value: participant quality assurance","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Epilepsy Study Consortium Inc.","duties_or_roles":"sponsorDuties code: 15; value: Adjudication Committee","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"sponsorDuties code: 15; value: Adjudication Committee","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Pharmaceutical company"}