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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03675776
Recruitment Status : Terminated (Business decision to stop the program.)
First Posted : September 18, 2018
Results First Posted : July 28, 2020
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Naurex, Inc, an affiliate of Allergan plc

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: Rapastinel Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Monotherapy in Patients With Major Depressive Disorder
Actual Study Start Date : October 30, 2018
Actual Primary Completion Date : July 11, 2019
Actual Study Completion Date : July 11, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Rapastinel 450mg
Rapastinel (prefilled syringe, weekly intravenous IV administration).
 Drug: Rapastinel
Rapastinel (prefilled syringe, weekly intravenous IV administration).
Experimental: Rapastinel 225mg
Rapastinel (prefilled syringe, weekly intravenous IV administration).
 Drug: Rapastinel
Rapastinel (prefilled syringe, weekly intravenous IV administration).
Placebo Comparator: Placebo
Placebo (prefilled syringe, weekly IV administration).
 Drug: Placebo
Placebo (prefilled syringe, weekly IV administration).


Outcome Measures
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Primary Outcome Measures :
  1. 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 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 :
  1. 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 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675776


Locations
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Sponsors and Collaborators
Naurex, Inc, an affiliate of Allergan plc
Investigators
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Study Director: Jenna Hoogerheyde Allergan
  Study Documents (Full-Text)

Documents provided by Naurex, Inc, an affiliate of Allergan plc:
Statistical Analysis Plan  [PDF] August 19, 2019
Study Protocol  [PDF] April 17, 2018

More Information
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Additional Information:

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Responsible Party: Naurex, Inc, an affiliate of Allergan plc
ClinicalTrials.gov Identifier: NCT03675776    
Other Study ID Numbers: RAP-MD-30
2018-000060-29 ( EudraCT Number )
First Posted: September 18, 2018    Key Record Dates
Results First Posted: July 28, 2020
Last Update Posted: July 28, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Naurex, Inc, an affiliate of Allergan plc:
Depression
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms