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Trial record 1 of 1 for:    rap-md-02
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A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-02)

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT02943564
First received: October 21, 2016
Last updated: June 15, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention Phase
Depressive Disorder, Major Drug: Rapastinel Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Allergan:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 1050
Actual Study Start Date: November 1, 2016
Estimated Study Completion Date: December 13, 2018
Estimated Primary Completion Date: December 13, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Rapastinel
Rapastinel pre-filled syringes for weekly IV injections.
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02943564

Contacts
Contact: Clinical Trials Registry Team 1-800-347-4500 IR-CTRegistration@allergan.com

  Show 66 Study Locations
Sponsors and Collaborators
Allergan
Investigators
Study Director: Robert Hayes, PhD Allergan
  More Information

Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02943564     History of Changes
Other Study ID Numbers: RAP-MD-02
Study First Received: October 21, 2016
Last Updated: June 15, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Depressive Disorder, Major
Depressive Disorder
Depression
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on June 22, 2017