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

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ClinicalTrials.gov Identifier: NCT03675776
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Naurex, Inc, an affiliate of Allergan plc

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 690 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
Estimated Primary Completion Date : December 25, 2020
Estimated Study Completion Date : December 25, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rapastinel 450mg
Rapastinel (prefilled syringe, weekly intravenous IV administration).
Drug: Rapastinel
Rapastinel (prefilled syringe, weekly intravenous IV administration).

Experimental: Rapasinel 225mg
Rapastinel (prefilled syringe, weekly intravenous IV administration).
Drug: Rapastinel
Rapastinel (prefilled syringe, weekly intravenous IV administration).

Placebo Comparator: Placebo
Placebo (prefilled syringe, wekly IV administration).
Drug: Placebo
Placebo (prefilled syringe, weekly IV administration).




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, 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 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, 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.



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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

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


Contacts
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Contact: Clinical Trials Registry Team 877‐277‐8566 IR-CTRegistration@Allergan.com

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Sponsors and Collaborators
Naurex, Inc, an affiliate of Allergan plc
Investigators
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Study Director: Marc Debelle Allergan

Additional Information:
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Responsible Party: Naurex, Inc, an affiliate of Allergan plc
ClinicalTrials.gov Identifier: NCT03675776     History of Changes
Other Study ID Numbers: RAP-MD-30
2018-000060-29 ( EudraCT Number )
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019

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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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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms