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A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-02)

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ClinicalTrials.gov Identifier: NCT02943564
Recruitment Status : Completed
First Posted : October 24, 2016
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Naurex, Inc, an affiliate of Allergan plc

Tracking Information
First Submitted Date  ICMJE October 21, 2016
First Posted Date  ICMJE October 24, 2016
Last Update Posted Date February 27, 2019
Actual Study Start Date  ICMJE November 1, 2016
Actual Primary Completion Date December 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 21, 2016)
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline and 1 Day ]
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.
Change History Complete list of historical versions of study NCT02943564 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2018)
Change from Baseline in MADRS Total Score [ Time Frame: Baseline and Day 1 ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2016)
Change from Baseline in 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-02)
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder
Brief Summary This study will evaluate the efficacy, safety, and tolerability of two doses of rapastinel, 225 milligrams (mg) and 450 mg, compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder, Major
Intervention  ICMJE
  • Drug: Rapastinel
    Rapastinel pre-filled syringes for weekly IV injections.
  • Drug: Placebo
    Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
Study Arms  ICMJE
  • Experimental: Rapastinel 225 mg
    Rapastinel 225 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.
    Intervention: Drug: Rapastinel
  • Experimental: Rapastinel 450 mg
    Rapastinel 450 mg 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.
    Intervention: Drug: Rapastinel
  • 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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 12, 2018)
658
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2016)
1050
Actual Study Completion Date  ICMJE December 18, 2018
Actual Primary Completion Date December 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02943564
Other Study ID Numbers  ICMJE RAP-MD-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Naurex, Inc, an affiliate of Allergan plc
Study Sponsor  ICMJE Naurex, Inc, an affiliate of Allergan plc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Robert Hayes, PhD Allergan
PRS Account Naurex, Inc, an affiliate of Allergan plc
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP