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

December 11, 2019 updated by: Naurex, Inc, an affiliate of Allergan plc

A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
658

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona Department of Psychiatry
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Woodland International Research Group
      • Rogers, Arkansas, United States, 72758
        • Woodland Research Northwest
    • California
      • Anaheim, California, United States, 92804
        • California Pharmaceutical Research Institute, Inc
      • Culver City, California, United States, 90230
        • ProScience Research Group
      • Glendale, California, United States, 91206
        • Behavioral Research Specialists, LLC
      • Lemon Grove, California, United States, 91945
        • Synergy Clinical Research Center Of Escondido
      • Oakland, California, United States, 94607
        • Pacific Research Partners; LLC.
      • Riverside, California, United States, 92506
        • CITrials
      • San Diego, California, United States, 92103
        • Artemis Institute for Clinical Research
      • San Diego, California, United States, 92108
        • PCSD Feighner Research
    • Florida
      • Gainesville, Florida, United States, 32607
        • Sarkis Clinical Trials
      • Hialeah, Florida, United States, 33012
        • Reliable Clinical Research
      • Homestead, Florida, United States, 33030
        • Advanced Research Institute of Miami
      • Lauderhill, Florida, United States, 33319
        • Innovative Clinical Research, INC
      • Miami, Florida, United States, 33183
        • International Research Associates, LLC
      • Ocala, Florida, United States, 34474
        • Sarkis Clinical Trials
      • Orange City, Florida, United States, 32763
        • Medical Research Group of Central Florida
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solutions, Inc
      • Orlando, Florida, United States, 32839
        • Millenia Psychiatry & Research, Inc
    • Georgia
      • Decatur, Georgia, United States, 30030
        • iResearch Atlanta, LLC
      • Smyrna, Georgia, United States, 30080
        • IRIS Research
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Great Lakes Clinical Trials
      • Hoffman Estates, Illinois, United States, 60169
        • Alexian Brothers Center for Psychiatric Research
      • Libertyville, Illinois, United States, 60048
        • Capstone Clinical Research
    • Kansas
      • Prairie Village, Kansas, United States, 66208
        • Phoenix Medical Research
      • Wichita, Kansas, United States, 67207
        • Heartland Research Associates
    • Louisiana
      • Lake Charles, Louisiana, United States, 70629
        • Lake Charles Clinical Trials
      • Shreveport, Louisiana, United States, 71104
        • J Gary Booker, MD APMC
    • Maryland
      • Baltimore, Maryland, United States, 21208
        • Pharmasite Research, Inc
      • Rockville, Maryland, United States, 20850
        • CBH Health
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Boston Clinical Trials
      • Methuen, Massachusetts, United States, 01844
        • ActivMed Practices & Research, Inc.
      • New Bedford, Massachusetts, United States, 02740
        • Btc of New Bedford
      • Weymouth, Massachusetts, United States, 02190
        • Coastal Research Associates
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Precise Research Centers
    • Missouri
      • Olivette, Missouri, United States, 63132
        • Millennium Psychiatric Associates
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08002
        • Center For Emotional Fitness
      • Marlton, New Jersey, United States, 08053
        • Pharmaceutical Research Associates Inc
    • New York
      • New York, New York, United States, 10128
        • The Medical Research Network, LLC
      • Staten Island, New York, United States, 10312
        • Richmond Behavioral Associates
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Richard H. Weisler, MD, PA
    • Ohio
      • Cincinnati, Ohio, United States, 45215
        • Patient Priority Clinical Site, LLC
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Department of Psychiatry
      • Garfield Heights, Ohio, United States, 44125
        • Charak Clinical Research Center
      • Mason, Ohio, United States, 45040
        • Professional Psychiatric Services
      • Mason, Ohio, United States, 45040
        • Lindner Center of Hope
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73118
        • Paradigm Research Professionals
      • Oklahoma City, Oklahoma, United States, 73112
        • Red River Medical Research Center, LLC
      • Oklahoma City, Oklahoma, United States, 73112
        • Sooner Clinical Research, Inc
    • Oregon
      • Portland, Oregon, United States, 97210
        • Summit Research Network
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Lehigh Center For Clinical Research
      • Media, Pennsylvania, United States, 19063
        • Suburban Research Associates
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Carolina Clinical Trials, Inc.
      • Mount Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Center, Inc.
    • Texas
      • Austin, Texas, United States, 78754
        • Community Clinical Research, Inc.
      • Austin, Texas, United States, 78759
        • BioBehavioral Research of Austin
      • Dallas, Texas, United States, 75243
        • Relaro Medical Trials
      • El Campo, Texas, United States, 77347
        • El Campo Clinical Trials
      • Houston, Texas, United States, 77090
        • Red Oak Psychiatry Associates, PA
      • Houston, Texas, United States, 77058
        • Earle Research
      • The Woodlands, Texas, United States, 77381
        • Family Psychiatry of The Wood
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • PRA Health Sciences
    • Washington
      • Bothell, Washington, United States, 98011
        • Pacific Institute of Medical Sciences
      • Everett, Washington, United States, 98201
        • Eastside Therapeutic Resource

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and 3 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Naurex, Inc, an affiliate of Allergan plc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 12, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 18, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 27, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RAP-MD-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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