Protocol Lay Person Short Title: A Trial of the Safety and Efficacy of Flexible Doses of SEP-363856 as Adjunctive Therapy in the Treatment of Adults with Major Depressive Disorder.
Key facts
- Where
- Budapest és Budapest III, MagyarországSee the 3 sites
- Phase
- 2/3. fázis
Where in Magyarország
- Processus KftBudapest, MagyarországNo longer taking part
- Semmelweis UniversityBudapest, MagyarországNo longer taking part
- Clinexpert Kft.Budapest III, MagyarországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Otsuka Pharmaceutical Development And Commercialization Inc.
- Trial code
- EU 2022-500538-27-00
- Record updated
- 2025. december 18.
- Original description
To compare the efficacy of SEP-363856 (50 to 75 mg/day) to placebo as adjunctive therapy to an assigned open-label ADT in subjects with MDD who demonstrate an inadequate response to a prospective 8-week trial of the same assigned open label ADT.Read full original descriptionShow less
A Phase 2/3, Multicenter, Randomized, Double blind, Placebo controlled Trial of the Safety and Efficacy of Flexible Doses of SEP 363856 as Adjunctive Therapy in the Treatment of Adults with Major Depressive Disorder.
To compare the efficacy of SEP-363856 (50 to 75 mg/day) to placebo as adjunctive therapy to an assigned open-label ADT in subjects with MDD who demonstrate an inadequate response to a prospective 8-week trial of the same assigned open label ADT.
Inclusion: The study population includes subjects 18 to 65 years of age inclusive at the time of consent with MDD as the main diagnosis and who are currently experiencing a major depressive episode (MDE) as determined by the DSM-5 criteria (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) and confirmed by the Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT) and appropriate clinical psychiatric assessment. The current MDE must have a duration of ≥ 8 weeks and < 2 years. In addition, subjects must have reported a history for the current MDE of an inadequate response to at least 1 and no more than 3 adequate ADTs. Subjects must also have a total score ≥ 18 at the screening and baseline visit on the 17-item Hamilton Depression Rating Scale (HAM-D17).
Exclusion: Any subject who, in the opinion of the clinical trial sponsor, investigator, or medical monitor, should not participate in the trial will be excluded.