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A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-01)

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: NCT02932943
Recruitment Status : Completed
First Posted : October 13, 2016
Results First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Naurex, Inc, an affiliate of Allergan plc

Brief Summary:
This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 465 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 : October 15, 2016
Actual Primary Completion Date : September 21, 2018
Actual Study Completion Date : November 8, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rapastinel 450 mg
Rapastinel 450 milligram (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.




Primary Outcome Measures :
  1. Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Trial [ 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.



Information from the National Library of Medicine

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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 stess 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): NCT02932943


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Locations
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United States, California
Southern California Research LLC.
Beverly Hills, California, United States, 90036
ATP Clinical Research Inc.
Costa Mesa, California, United States, 92626
Pharmacology Research Institute
Encino, California, United States, 91316
Collaborative Neuroscience Network, LLC
Garden Grove, California, United States, 92845
Synergy San Diego
Lemon Grove, California, United States, 91945
Pharmacology Research Institute
Los Alamitos, California, United States, 90720
Excell Research
Oceanside, California, United States, 92056
Anderson Clinical Research
Redlands, California, United States, 92374
Thomas M. Shiovitz, M.D., Inc., DBA California Neuroscience Research Medical Group, Inc.,
Sherman Oaks, California, United States, 91403
Viking Clinical Research
Temecula, California, United States, 92591
Pacific Clinical Research Medical
Upland, California, United States, 91786
United States, Connecticut
Comprehensive Psychiatric Care
Norwich, Connecticut, United States, 06360
United States, Florida
Meridien Research
Bradenton, Florida, United States, 34201
MD Clinical
Hallandale Beach, Florida, United States, 33009
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, United States, 32256
Meridien Research
Lakeland, Florida, United States, 33805
United States, Georgia
Institute for Advanced Medical Research
Alpharetta, Georgia, United States, 30005
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
United States, Massachusetts
Adams Clinical Trials
Watertown, Massachusetts, United States, 02472
United States, Nevada
Altea Research
Las Vegas, Nevada, United States, 89102
United States, New York
Bioscience Research
Mount Kisco, New York, United States, 10549
Eastside Comprehensive Medical Center, LLC
New York, New York, United States, 10128
Finger Lakes Clinical Research
Rochester, New York, United States, 14618
United States, Ohio
Neuro-Behavioral Clinical Research, Inc
Canton, Ohio, United States, 44718
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Midwest Clinical Research Center LLC
Dayton, Ohio, United States, 45417
United States, Oklahoma
IPS Research
Oklahoma City, Oklahoma, United States, 73103
United States, Tennessee
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee, United States, 38119
United States, Texas
Donald J. Garcia, Jr., MD, PA
Austin, Texas, United States, 78737
Clinical Trials of Texas
San Antonio, Texas, United States, 78229
United States, Washington
NorthWest Clinical Research Center
Bellevue, Washington, United States, 98007
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] December 7, 2018
Statistical Analysis Plan  [PDF] December 10, 2018


Additional Information:
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Responsible Party: Naurex, Inc, an affiliate of Allergan plc
ClinicalTrials.gov Identifier: NCT02932943     History of Changes
Other Study ID Numbers: RAP-MD-01
First Posted: October 13, 2016    Key Record Dates
Results First Posted: October 11, 2019
Last Update Posted: October 11, 2019
Last Verified: September 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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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms