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Study of Rapastinel as Monotherapy in Patients With MDD

Phase 3
Terminated
Conditions
Depressive Disorder, Major
Interventions
Drug: Placebo
Registration Number
NCT03560518
Lead Sponsor
Naurex, Inc, an affiliate of Allergan plc
Brief Summary

The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) and 900 milligrams (mg) of Rapastinel, compared to placebo in participants with major depressive disorder (MDD).

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
439
Inclusion Criteria
  • Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD
  • Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1
  • Treatment naive in the current episode or have inadequate response to 1-3 antidepressant therapies given at adequate dose and duration in the current episode
  • If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test
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:
  • Schizophrenia spectrum or other psychotic disorder
  • Bipolar or related disorder
  • Major neurocognitive disorder
  • 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
  • Dissociative disorder
  • Posttraumatic stress disorder
  • MDD with psychotic features
  • Significant suicide risk, as judged by the Investigator

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboPlacebo (prefilled syringe, weekly IV administration)
Rapastinel 450mgRapastinelRapastinel 450 mg (prefilled syringe, weekly intravenous IV administration)
Rapastinel 900mgRapastinelRapastinel 900 mg (prefilled syringe, weekly intravenous IV administration)
Primary Outcome Measures
NameTimeMethod
Change From Baseline on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at End of Treatment (End of Week 6)Baseline to end of Week 6

The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.

Secondary Outcome Measures
NameTimeMethod
Change From Baseline in MADRS Total Score at Day 1 Post-first Dose of TreatmentBaseline to Day 1 post-first dose

The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.

Trial Locations

Locations (40)

Alea Research

🇺🇸

Phoenix, Arizona, United States

Woodland International Research Group

🇺🇸

Little Rock, Arkansas, United States

California Pharmaceutical Research Institute, Inc.

🇺🇸

Anaheim, California, United States

Collaborative Neuroscience Network

🇺🇸

Garden Grove, California, United States

Synergy Research San Diego

🇺🇸

National City, California, United States

Excell Research Inc.

🇺🇸

Oceanside, California, United States

NRC Research Institute

🇺🇸

Orange, California, United States

Artemis Institute for Clinical Research

🇺🇸

San Diego, California, United States

California Neuroscience Research Medical Group,Inc.

🇺🇸

Sherman Oaks, California, United States

Viking Clinical Research Ltd.

🇺🇸

Temecula, California, United States

Scroll for more (30 remaining)
Alea Research
🇺🇸Phoenix, Arizona, United States

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