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Depressive Disorder, MajorPhase 3NCT03002077

Long-term Safety Study of Rapastinel as Adjunctive Therapy in Patients With Major Depressive Disorder

A Phase 3 study testing Rapastinel in people with Depressive Disorder, Major, run by Naurex, Inc, an affiliate of Allergan plc at 128 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will evaluate the long-term safety and tolerability of rapastinel as an adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Depressive Disorder, Major
What is being tested?
Rapastinel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
617 participants
Where
128 sitesUnited States
Study dates
3 Feb 2017to 6 Dec 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 Screening
  • 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.

Who cannot join

  • DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Screening
  • Lifetime history of meeting DSM-5 criteria for:
  • Schizophrenia spectrum or other psychotic disorder
  • Bipolar or related disorder
  • Major neurocognitive disorder
  • 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
Show all 10Show fewer
  • Dissociative disorder
  • Posttraumatic stress disorder
  • MDD with psychotic features
  • Significant suicide risk, as judged by the Investigator.

Trial locations and contacts

128 sites in 1 country.

128 sites in 1 country

United States128 sites

  • Albuquerque Neuroscience, Inc

    Albuquerque, New Mexico, 87109

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania, 18104

  • California Pharmaceutical Research Institute, Inc

    Anaheim, California, 92804

  • Institute for Advanced Medical Research

    Atlanta, Georgia, 30005

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30331

  • Donald J. Garcia, Jr., MD, PA

    Austin, Texas, 78737

  • Community Clinical Research, Inc.

    Austin, Texas, 78754

  • BioBehavioral Research of Austin

    Austin, Texas, 78759

  • Sheppard Pratt Health System

    Baltimore, Maryland, 21204

  • Pharmasite Research, Inc

    Baltimore, Maryland, 21208

  • Houston Clinical Trials, LLC

    Bellaire, Texas, 77401

  • NorthWest Clinical Research Center

    Bellevue, Washington, 98007

  • Hassman Research Institute, LLC

    Berlin, New Jersey, 08009

  • Southern California Research LLC.

    Beverly Hills, California, 90036

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Boston Clinical Trials

    Boston, Massachusetts, 02131

  • Pacific Institute of Medical Sciences

    Bothell, Washington, 98011

  • Meridien Research

    Bradenton, Florida, 34201

  • SPRI Clinical Trials, Inc

    Brooklyn, New York, 11235

  • Neuro-Behavioral Clinical Research, Inc

    Canton, Ohio, 44718

  • Carolina Clinical Trials, Inc.

    Charleston, North Carolina, 29407

  • New Hope Clinical Research Inc.

    Charlotte, North Carolina, 28211

  • Psychiatric Alliance of the Blue Ridge, Inc.

    Charlottesville, Virginia, 22903

  • Center for Emotional Fitness

    Cherry Hill, New Jersey, 08002

  • Great Lakes Clinical Trials

    Chicago, Illinois, 60640

  • Patient Priority Clinical Site, LLC

    Cincinnati, Ohio, 45215

  • MCB Clinical Research Center

    Colorado Springs, Colorado, 80910

  • The Ohio State University Department of Psychiatry

    Columbus, Ohio, 43210

  • ATP Clinical Research Inc.

    Costa Mesa, California, 92626

  • ProScience Research Group

    Culver City, California, 90230

  • Relaro Medical Trials

    Dallas, Texas, 75243

  • Midwest Clinical Research Center LLC

    Dayton, Ohio, 45417

  • iResearch Atlanta, LLC

    Decatur, Georgia, 30030

  • Harmonex, Inc.

    Dothan, Alabama, 36303

  • El Campo Clinical Trials

    El Campo, Texas, 77347

  • Precise Research Centers

    Flowood, Mississippi, 39232

  • Gulfcoast Clinical Research Center

    Fort Myers, Florida, 33912

  • North Texas Clinical Trials

    Fort Worth, Texas, 76104

  • Sarkis Clinical Trials

    Gainesville, Florida, 32607

  • CBH Health

    Gaithersburg, Maryland, 20850

  • Collaborative Neuroscience Network, LLC

    Garden Grove, California, 92845

  • Charak Clinical Research Center

    Garfield Heights, Ohio, 44125

  • Behavioral Research Specialists, LLC

    Glendale, California, 91206

  • MD Clinical

    Hallandale, Florida, 33009

  • Reliable Clinical Research

    Hialeah, Florida, 33012

  • Alexian Brothers Center for Psychiatric Research

    Hoffman Estates, Illinois, 60169

  • Earle Research

    Houston, Texas, 77058

  • Red Oak Psychiatry Associates, PA

    Houston, Texas, 77090

  • Sun Valley Research Center

    Imperial, California, 92251

  • Irvine Center for Clinical Research, Inc

    Irvine, California, 92614

  • Clinical Neuroscience Solutions, Inc

    Jacksonville, Florida, 32256

  • Lake Charles Clinical Trials

    Lake Charles, Louisiana, 70629

  • Meridien Research

    Lakeland, Florida, 33805

  • Altea Research

    Las Vegas, Nevada, 89102

  • Innovative Clinical Research, Inc

    Lauderhill, Florida, 33319

  • Synergy Clinical Research Center of Escondido

    Lemon Grove, California, 91945

  • Synergy San Diego

    Lemon Grove, California, 91945

  • Capstone Clinical Research

    Libertyville, Illinois, 60048

  • Premier Psychiatric Research Institute, LLC

    Lincoln, Nebraska, 68526

  • Woodland International Research Group

    Little Rock, Arkansas, 72211

  • Pharmacology Research Institute

    Los Alamitos, California, 90720

  • Northwest Behavioral Research Center

    Marietta, Georgia, 30060

  • Pharmaceutical Research Associates Inc

    Marlton, New Jersey, 08053

  • Lindner Center of Hope

    Mason, Ohio, 45040

  • Professional Psychiatric Services

    Mason, Ohio, 45040

  • Suburban Research Associates

    Media, Pennsylvania, 19063

  • Clinical Neuroscience Solutions, Inc

    Memphis, Tennessee, 38119

  • Research Strategies of Memphis, LLC

    Memphis, Tennessee, 38119

  • ActivMed Practices & Research, Inc.

    Methuen, Massachusetts, 01844

  • Innova Clinical Trials Inc.

    Miami, Florida, 33145

  • International Research Associates, LLC

    Miami, Florida, 33183

  • Bioscience Research

    Mount Kisco, New York, 10549

  • Coastal Carolina Research Center, Inc.

    Mt. Pleasant, South Carolina, 29464

  • AMR - Baber Research, Inc.

    Naperville, Illinois, 60563

  • Healthy Perspectives - Innovative Mental Health Services. PLLC

    Nashua, New Hampshire, 03060

  • Manhattan Behavioral Medicine

    New York, New York, 10022

  • Eastside Comprehensive Medical Center, LLC

    New York, New York, 10128

  • The Medical Research Network, LLC

    New York, New York, 10128

  • Fieve Clinical Research

    New York, New York, 10168

  • Keystone Clinical Studies, LLC

    Norristown, Pennsylvania, 20006

  • Comprehensive Psychiatric Care

    Norwich, Connecticut, 06360

  • Psychiatric Care and Research Center

    O'Fallon, Missouri, 63368

  • Pacific Research Partners; LLC.

    Oakland, California, 94607

  • Research Centers of America

    Oakland Park, Florida, 33334

  • Excell Research

    Oceanside, California, 92056

  • IPS Research

    Oklahoma City, Oklahoma, 73103

  • Red River Medical Research Center, LLC

    Oklahoma City, Oklahoma, 73112

  • Sooner Clinical Research, Inc

    Oklahoma City, Oklahoma, 73112

  • Paradigm Research Professionals

    Oklahoma City, Oklahoma, 73118

  • NRC Research Institute

    Orange, California, 92868

  • Medical Research Group of Central Florida

    Orange City, Florida, 32763

  • Clinical Neuroscience Solutions, Inc

    Orlando, Florida, 32801

  • Combined Research Orlando Phase I-IV

    Orlando, Florida, 32807

  • Millenia Psychiatry & Research, Inc

    Orlando, Florida, 32839

  • Psychiatric Associates

    Overland Park, Kansas, 66211

  • Asclepes Research Centers

    Panorama City, California, 91402

  • NoesisPharma

    Phoenix, Arizona, 85032

  • Summit Research Network

    Portland, Oregon, 97210

  • Global Medical Institute, LLC

    Princeton, New Jersey, 08540

  • Richard H. Weisler, MD, PA

    Raleigh, North Carolina, 27609

  • Anderson Clinical Research

    Redlands, California, 92374

  • CITrials

    Riverside, California, 92506

  • Finger Lakes Clinical Research

    Rochester, New York, 14618

  • Woodland Research Northwest

    Rogers, Arkansas, 72758

  • St. Charles Psychiatric Associates - Midwest Research Group

    Saint Charles, Missouri, 63304

  • Psychiatric and Behavioral Solutions

    Salt Lake City, Utah, 84105

  • Pharmaceutical Research Associates, Inc

    Salt Lake City, Utah, 84106

  • Clinical Trials of Texas

    San Antonio, Texas, 78229

  • Artemis Institute for Clinical Research

    San Diego, California, 92103

  • PCSD Feighner Research

    San Diego, California, 92108

  • Artemis Institute for Clinical Research

    San Marcos, California, 92078

  • Thomas M. Shiovitz, M.D., Inc., DBA California Neuroscience Research Medical Group, Inc.,

    Sherman Oaks, California, 91403

  • Louisiana Clinical Research

    Shreveport, Louisiana, 71101

  • J Gary Booker, MD APMC

    Shreveport, Louisiana, 71104

  • Iris Research

    Smyrna, Georgia, 30080

  • Coastal Research Associates

    South Weymouth, Massachusetts, 02190

  • Millennium Psychiatric Associates

    St Louis, Missouri, 63141

  • Richmond Behavioral Associates

    Staten Island, New York, 10312

  • Olympian Clinical Research

    Tampa, Florida, 33609

  • University of South Florida, Psychiatry and Behavioral Neurosciences

    Tampa, Florida, 33613

  • Viking Clinical Research

    Temecula, California, 92591

  • Family Psychiatry of The Wood

    The Woodlands, Texas, 77381

  • Bio Behavioral Health

    Toms River, New Jersey, 08755

  • Pacific Clinical Research Medical

    Upland, California, 91786

  • Adams Clinical Trials

    Watertown, Massachusetts, 02472

  • Heartland Research Associates

    Wichita, Kansas, 67207

  • Grayline Clinical Drug Trials

    Wichita Falls, Texas, 76309

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: An Open-label, Long-term Safety Study of Rapastinel as Adjunctive Therapy in Patients With Major Depressive Disorder

This study will evaluate the long-term safety and tolerability of rapastinel as an adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD).

Being tested
Rapastinel
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RapastinelDrug

    Rapastinel pre-filled syringes for IV injections.

Study groups in NCT03002077
Study groupRoleWhat they receive
RapastinelExperimentalRapastinel 450 milligrams (mg) intravenous (IV) open label weekly or every two weeks, based on investigator's discretion for 52 Weeks.
Receives: Drug: Rapastinel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

    Measured: 52 Weeks

Secondary outcomes (2)

  1. Change From Baseline in Brief Psychiatric Rating Scale Positive Symptoms Subscale (BPRS+)

    The BPRS+ is a subset of the BPRS that assesses 4 components of the BPRS+ related to the degree of psychosis: Conceptual Disorganization, Suspiciousness, Hallucinatory Behavior, and Unusual Thought Content assessed by the investigator using a 7-point scale ranging from 1=Not Present to 7=Extremely Severe for a total possible score of 0 (best) to 28 (worst). A negative change from Baseline indicates improvement.

    Measured: Baseline to 52 Weeks

  2. Change From Baseline in the Clinician Administered Dissociative States Scale (CADSS)

    The Clinician Administered Dissociative States Scale (CADSS) is a clinician-administered measure of perceptual, behavioral, and attentional alterations occurring during active dissociative experiences composed of 23 subjective self-reported and 5 objective observer-reported ratings, each scored from 0 (not at all) to 4 (extremely). Only the 23 subjective items will be collected and analyzed. The sum of each of the 23 subjective items was used for a total score of 0-92. A negative change from Baseline indicates improvement.

    Measured: Baseline to 52 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2016 (estimated)
  2. Study start3 Feb 2017
  3. Primary completion6 Dec 2018
  4. Study completion6 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
617 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03002077
Sponsor's protocol ID
RAP-MD-06
Status last verified
Jun 2020
First submitted
21 Dec 2016
Last updated
22 Jun 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rapastinel in people with Depressive Disorder, Major, run by Naurex, Inc, an affiliate of Allergan plc at 128 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 128 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: 52 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03002077.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020; AzTrials last refreshed its copy on 6 Nov 2026.

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