NCT03668600

Study of Adjunctive or Monotherapy Rapastinel Treatment in Patients With Major Depressive Disorder (MDD)

An Open-label, Long-term Extended Access Protocol for Rapastinel as Adjunctive or Monotherapy Treatment in Patients With Major Depressive Disorder

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Naurex, Inc, an affiliate of Allergan plc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, open-label, long-term extended access treatment protocol in adult patients with a primary diagnosis of MDD.

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	Rapastinel	Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)

Timeline

• Start date: 2018-08-23
• Primary completion: 2019-07-03
• Completion: 2019-07-03
• First posted: 2018-09-12
• Last updated: 2020-07-17
• Results posted: 2020-07-17

Locations

74 sites across 1 country: United States

Regulatory

• FDA-regulated drug study