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Trial record 3 of 3 for:    allergan Rapastinel gainesville

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

This study is currently recruiting participants.
Verified November 2017 by Allergan
Sponsor:
ClinicalTrials.gov Identifier:
NCT02943564
First Posted: October 24, 2016
Last Update Posted: November 7, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  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: 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

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

Information from the National Library of Medicine

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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
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): NCT02943564


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

  Show 67 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
First Submitted: October 21, 2016
First Posted: October 24, 2016
Last Update Posted: November 7, 2017
Last Verified: November 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
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms