Study of monotherapy Rapastinel in patients with Major Depressive Disorder (MDD)
- Conditions
- Depressive Disorder, Major
- Registration Number
- JPRN-jRCT2080224073
- Lead Sponsor
- Allergan Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- terminated
- Sex
- All
- Target Recruitment
- 690
Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition [DSM-5] criteria for MDD
- Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1
- Treatment naive in the current episode or have inadequate response to 1-3 antidepressant therapies given at adequate dose and duration in the current episode
- If female of childbearing potential, have a negative serum beta-human chorionic gonadotropin [beta-hCG] pregnancy test
- DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1
- Lifetime history of meeting DSM-5 criteria for:
1.Schizophrenia spectrum or other psychotic disorder
2.Bipolar or related disorder
3.Major neurocognitive disorder
4.Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
5.Dissociative disorder
6.Posttraumatic stress disorder
7.MDD with psychotic features
- Significant suicide risk, as judged by the Investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method