Major depressive disorder
Conditions
Interventions
Sponsors
Murakami Kanako
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Established diagnosis of MDD with a duration of current depressive episode >= 8 weeks at the time of screening visit -Hamilton Depression Rating Scale 17 - Severity scale score >17 -A documented ongoing monotherapy treatment of >= 6 weeks at the randomization visit, with an SSRI or SNRI at adequate dose -In the current episode, participants have shown insufficient treatment response -Male and female participants, 18 to 65 years of age at the time of consent. -Women who are of childbearing potential must be able and willing, to use two methods of contraception.
Exclusion criteria
Exclusion criteria: - Had ever met diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, or delusional disorder - Diagnosis with antisocial, paranoid, schizoid or schizotypal personality disorder, or MDD with psychotic features - Any other personality disorder that significantly affects current psychiatric status and likely to impact trial participation, as per the judgement of investigator. - Diagnosis of any other mental disorder that was the primary focus of treatment within 6 months prior to screening - A current or recent history of clinically significant suicidal ideation with intent within the past 3 months or a suicidal attempt within the past year - Diagnosis of a moderate to severe substance related disorder within 6 months prior to consent (with exception of caffeine and tobacco). - Positive drug screen (amphetamines, opiates, cocaine, barbiturates, phencyclidine) - Have started psychotherapy or other non-drug therapies (e.g. acupuncture, hypnosis) within 3 months prior to consent or plan to start at any time during the study - Use of alternative or traditional medicine (e.g. Chinese traditional medicine, herbal medication, St. John's wort etc.) within 14 days prior to randomization and during the entire course of the study - Use of NMDA inhibitors (including ketamine/esketamine) for the current ongoing depressive episode or any past treatment failure with ketamine. - Use of psychotropic medication, outside of ongoing SSRI/SNRI monotherapy and certain exceptions, which was not discontinued at least 5 half-lives prior to randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Day 8 | — |
Countries
Belgium, Bulgaria, China, Czech Republic, Germany, Japan, USA
Contacts
Public ContactInquiry Receipt Center jRCT
IQVIA Services Japan G.K.
Outcome results
None listed