(1S)-1-[4-[3-[4-(6-FLUORO-1,2-BENZOXAZOL-3-YL)PIPERIDIN-1-YL]PROPOXY]-3-METHOXYPHENYL]ETHANOL for Major depressive disorder

Inclusion criteria

• {"criterion_text":"- Meets DSM-5-TR criteria for MDD as confirmed by the Investigator and/or Sponsor-approved interviewer/rater via both: the Structural Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT), updated for DSM-5-TR, and review of the patient’s medical records/history (a phone call with the patient’s physician may be acceptable in lieu of medical records), or, if lacking adequate records, written approval from the Sponsor or Sponsor’s Designee;"}
• {"criterion_text":"- The start of the current major depressive episode (MDE) is at least 8 weeks but no more than 24 months prior to screening;"}
• {"criterion_text":"- Rater-administered MADRS total score ≥ 24 at Screening and at Baseline;"}
• {"criterion_text":"- CGI-S – Severity of Illness score of ≥ 4 at Screening and Baseline;"}
• {"criterion_text":"- Quick Inventory of Depressive Symptomatology-Self Report-16 item (QIDS-SR-16) score ≥ 14 at Screening and at Baseline;"}
• {"criterion_text":"- Currently having an inadequate response to antidepressant therapy (less than 50% improvement), as confirmed by the Investigator using the Antidepressant Treatment Response Questionnaire (ATRQ) and taking at least the minimum effective dose (per package insert) of one of the following antidepressants as monotherapy treatment for at least 6 weeks duration prior to the Screening Visit: bupropion, citalopram, duloxetine, escitalopram, fluoxetine, levomilnacipran (if locally approved for MDD), milnacipran (if locally approved for MDD), paroxetine, sertraline, venlafaxine, desvenlafaxine, vilazodone, vortioxetine"}

Exclusion criteria

• {"criterion_text":"- Within the patient's lifetime, has a confirmed DSM-5-TR psychiatric diagnosis other than MDD, including: Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder; Bipolar Disorder;"}
• {"criterion_text":"- Diagnosis of any current (within 6 months) psychiatric diagnosis other than MDD that has been confirmed by DSM-5-TR including: Anxiety disorders such as Panic Disorder or Generalized Anxiety Disorder; Obsessive-compulsive Disorder; Posttraumatic Stress Disorder. Note: Anxiety symptoms may be allowed if secondary to MDD, provided these symptoms do not require concurrent treatment; Patients with history of GAD documented on their MR may be included if the Investigator provides sufficient evidence that the diagnosis is no longer applicable. Eating disorder; Personality disorder of sufficient severity to have a major impact on the patient's psychiatric status;"}
• {"criterion_text":"- Experiences a ≥ 25% decrease in the MADRS total score between Screening and Baseline;"}
• {"criterion_text":"- Experiences a ≥ 25% decrease in the QIDS-SR-16 total score between Screening and Baseline;"}
• {"criterion_text":"- In the opinion of the Investigator, has a significant risk for suicidal behavior during participation in the study or is considered to be in imminent danger to themselves or others. Any of the following categorically exclude a patient from participation: at Screening, the patient scores \"yes\" on Suicidal Ideation Items 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening, or at Baseline, the patient scores \"yes\" on Suicidal Ideation Items 4 or 5 since the Screening Visit; at Screening, the patient has had 1 or more suicide attempts within 2 years prior to Screening; or at Screening or Baseline, the patient scores ≥ 5 on MADRS Item 10 (Suicidal Thoughts)."}
• {"criterion_text":"- Has a first MDE at age 60 years or older."}

Primary endpoints

• {"endpoint_text":"- Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)","definition_or_measurement_approach":"Change from baseline to Week 6 in MADRS Total Score (as stated in main objective: measured by change from baseline to Week 6 in the MADRS Total Score)."}

Other endpoints

• {"endpoint_text":"- To evaluate the efficacy of milsaperidone as an adjunct to antidepressant therapy for patients with MDD as measured by change from baseline in the Clinical Global Impression of Severity (CGI-S)","definition_or_measurement_approach":"Change from baseline in CGI-S"}
• {"endpoint_text":"- To evaluate the efficacy of milsaperidone as an adjunct to antidepressant therapy for patients with MDD as measured by improvements in the Clinical Global Impression of Change (CGI-C)","definition_or_measurement_approach":"Improvements in CGI-C"}
• {"endpoint_text":"- To evaluate the efficacy of milsaperidone as an adjunct to antidepressant therapy for patients with MDD as measured by change from baseline in MADRS Total Score","definition_or_measurement_approach":"Change from baseline in MADRS Total Score"}
• {"endpoint_text":"- To assess the safety and tolerability of milsaperidone compared to placebo adjunct to antidepressant therapy in the treatment of MDD as measured by spontaneous reporting of adverse events (AEs)","definition_or_measurement_approach":"Safety/tolerability assessed by spontaneous reporting of adverse events (AEs)"}
• {"endpoint_text":"- To evaluate the effect of milsaperidone on serum urate levels as measured by change from baseline analysis and frequency of shifts above upper limit normal","definition_or_measurement_approach":"Change from baseline analysis in serum urate levels and frequency of shifts above the upper limit of normal"}
• {"endpoint_text":"- To evaluate the effect of milsaperidone/urate interaction with factors such as genetic variants and demographics, on serum urate levels as measured by change from baseline analysis, and frequency of shifts above the upper limit normal","definition_or_measurement_approach":"Change from baseline in serum urate levels and analysis of shifts above ULN with interaction analyses by genetic variants and demographics"}

Bulgaria

Earliest CTIS Part Ii Submission Date

27-05-2025

Latest Decision Or Authorization Date

11-02-2026

Processing Time Days

260

Number Of Sites

9

Number Of Participants

100

Poland

Earliest CTIS Part Ii Submission Date

20-05-2025

Latest Decision Or Authorization Date

25-03-2026

Processing Time Days

309

Number Of Sites

9

Number Of Participants

100

Czechia

Earliest CTIS Part Ii Submission Date

13-05-2025

Latest Decision Or Authorization Date

06-03-2026

Processing Time Days

297

Number Of Sites

7

Number Of Participants

100

Primary sponsor

Full Name

Vanda Pharmaceuticals Netherlands B.V.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Netherlands

Third parties

• {"country":"United Kingdom","full_name":"Acm Global Central Laboratory Limited","duties_or_roles":"Listed as a third party (organisation type: Laboratory/Research/Testing facility); sponsorDuties entry present (code: 4)","organisation_type":"Laboratory/Research/Testing facility"}