Study of monotherapy Rapastinel in the prevention of relapse in patients with Major Depressive Disorder (MDD)

A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel in the Prevention of Relapse in Patients with Major Depressive Disorder

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224140

Enrollment

600

Registered

2018-11-08

Start date

2018-12-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder, Major

Interventions

investigational material(s) Generic name etc : Rapastinel INN of investigational material : Rapastinel Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Investigational

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
efficacy Time to first relapse during the 52 weeks of the Double-Blind Treatment Period (DBTP) 52weeks	—

Secondary

Measure	Time frame
other -	—

Countries

Europe, Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026