Study of monotherapy Rapastinel in the prevention of relapse in patients with Major Depressive Disorder (MDD)
- Conditions
- Depressive Disorder, Major
- Registration Number
- JPRN-jRCT2080224140
- Lead Sponsor
- Allergan Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- terminated
- Sex
- All
- Target Recruitment
- 600
Sex: All
Min. Age: 18 Years
Max. Age: 75 Years
- Completion of Study RAP-MD-30, RAP-MD-31, or RAP-MD-32
- 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