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A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-03)

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: NCT02943577
Recruitment Status : Completed
First Posted : October 24, 2016
Results First Posted : November 13, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Naurex, Inc, an affiliate of Allergan plc

Study Description
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Brief Summary:
This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 milligrams (mg) compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.

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 : 429 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder
Actual Study Start Date : November 2, 2016
Actual Primary Completion Date : October 26, 2018
Actual Study Completion Date : November 21, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Rapastinel 450 mg
Rapastinel 450 mg weekly intravenous (IV) injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
 Drug: Rapastinel
Rapastinel pre-filled syringes for weekly IV injections.
Placebo Comparator: Placebo
Placebo-matching rapastinel weekly IV injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
 Drug: Placebo
Placebo-matching rapastinel pre-filled syringes for weekly IV injections.


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Study [ Time Frame: Baseline and 3 Weeks ]
    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 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 [ Time Frame: Baseline and Day 8 ]
    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 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.

  2. Change From Baseline to Day 21 in MADRS Total Score for the Placebo Non-responders of mITT Population [ Time Frame: Baseline and Day 21 ]
    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 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.

  3. Change From Baseline to Day 8 in MADRS Total Score for the Placebo Non-responders of mITT Population [ Time Frame: Baseline and Day 8 ]
    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 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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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 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
  • Have no more than partial response (< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant
  • 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): NCT02943577


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:
Study Protocol  [PDF] November 20, 2018
Statistical Analysis Plan  [PDF] January 25, 2019

More Information
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Additional Information:

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Responsible Party: Naurex, Inc, an affiliate of Allergan plc
ClinicalTrials.gov Identifier: NCT02943577    
Other Study ID Numbers: RAP-MD-03
First Posted: October 24, 2016    Key Record Dates
Results First Posted: November 13, 2019
Last Update Posted: November 13, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms