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

• Status: Terminated
• Trial end date: 2019-07-03
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Naurex, Inc, an affiliate of Allergan plc

Criteria

Inclusion Criteria:

• Completion of lead-in study

• Adequate therapeutic benefit in the lead-in study to justify continuation of treatment with rapastinel in the judgement of the investigator

Exclusion Criteria:

• Suicide risk, as determined by meeting any of the following criteria:

1. A suicide attempt within the past year

2. Significant risk, as judged by the investigator, based on the psychiatric interview or information collected in the Columbia- Suicide Severity Rating Scale (C-SSRS) at any visit in the lead-in study

3. Montgomery-Asberg Depression Rating Scale (MADRS) Item 10 score ≥ 5 at any visit during participation in the lead-in study where MADRS was conducted.

• At imminent risk of injuring self or others or causing significant damage to property, as judged by the investigator

• Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during participation

• Females of childbearing potential and male partners of females of childbearing potential, not using a reliable means of contraception