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

Overview

The study will evaluate the efficacy, safety, and tolerability of 225 milligrams (mg) and 450 milligrams (mg) of Rapastinel, compared to placebo in participants with major depressive disorder (MDD).

Full Title of Study: “A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Monotherapy in Patients With Major Depressive Disorder”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 11, 2019

Interventions

  • Drug: Rapastinel
    • Rapastinel (prefilled syringe, weekly intravenous IV administration).
  • Drug: Placebo
    • Placebo (prefilled syringe, weekly IV administration).

Arms, Groups and Cohorts

  • Experimental: Rapastinel 450mg
    • Rapastinel (prefilled syringe, weekly intravenous IV administration).
  • Experimental: Rapasinel 225mg
    • Rapastinel (prefilled syringe, weekly intravenous IV administration).
  • Placebo Comparator: Placebo
    • Placebo (prefilled syringe, wekly IV administration).

Clinical Trial Outcome Measures

Primary Measures

  • Change from Baseline on Montgomery-Asberg Depression Rating Scale (MADRS) total score at end of double-blind treatment (end of week 6).
    • Time Frame: Baseline to end of Week 6
    • The MADRS, a clinician-rated scale, will be used to assess depressive symptomatology. Participants are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite,difficulty concentrating, and lack of interest. Each item will be scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity.

Secondary Measures

  • Change from Baseline in MADRS total score at 1 Day after first dose of treatment
    • Time Frame: Baseline to 1 Day post-first dose
    • The MADRS, a clinician-rated scale, will be used to assess depressive symptomatology. Participants are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item will be scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity.

Participating in This Clinical Trial

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:

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Naurex, Inc, an affiliate of Allergan plc
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Marc Debelle, Study Director, Allergan

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