NCT03855865

Study of Rapastinel as Monotherapy in Major Depressive Disorder (MDD)

A Randomized, Double-blind, Placebo- and Active- Controlled, Multicenter Study of Rapastinel as Monotherapy in Major Depressive Disorder

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Naurex, Inc, an affiliate of Allergan plc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) of Rapastinel, compared to 10 mg of Vortixetine and placebo in participants with major depressive disorder (MDD).

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	Rapastinel	Rapastinel (prefilled syringe, weekly intravenous IV administration).
DRUG	Vortioxetine	Vortixetine (10 mg with available dose increase to vortioxetine 20 mg oral daily after 3 weeks of administration).
DRUG	Placebo	Placebo (prefilled syringe, weekly IV administration or oral daily).

Timeline

• Start date: 2019-07-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2019-02-27
• Last updated: 2019-07-19

Regulatory

• FDA-regulated drug study