Depressive Disorder, MajorPhase 3NCT02943564

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

A Phase 3 study testing Rapastinel in people with Depressive Disorder, Major, run by Naurex, Inc, an affiliate of Allergan plc at 66 sites in United States.

Completed

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

Official record

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Trial 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. 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?: Yes, some participants may receive a placebo
How many people: 658 participants
Where: 66 sitesUnited States
Study dates: 1 Nov 2016to 18 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 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.

Who cannot join

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:
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

66 sites in 1 country.

City, postcode or hospital

66 sites in 1 country

United States66 sites

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

Other trials in United States

About this study

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

Conditions: Depressive Disorder, Major
Being tested: Rapastinel, Placebo
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 weekly IV injections.
PlaceboDrug
Placebo-matching rapastinel pre-filled syringes for weekly IV injections.

Study groups in NCT02943564
Study group	Role	What they receive
Rapastinel 225 mg	Experimental	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. Receives: Drug: Rapastinel
Rapastinel 450 mg	Experimental	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. Receives: Drug: Rapastinel
Placebo	Placebo comparator	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. Receives: Drug: Placebo

What is being measured

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

Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Study
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.
Measured: Baseline and 3 Weeks

Secondary outcomes (1)

Change From Baseline in MADRS Total Score
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.
Measured: Baseline and Day 8

Timeline

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

1 Nov 201618 Dec 2018

First posted24 Oct 2016 (estimated)
Study start1 Nov 2016
Primary completion12 Dec 2018
Study completion18 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 658 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02943564
Sponsor's protocol ID: RAP-MD-02
Status last verified: Dec 2019
First submitted: 21 Oct 2016
Last updated: 27 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Depressive Disorder, Major trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder
ClinicalTrials.gov ID: NCT02943564
Acronym / sponsor ID: RAP-MD-02
Conditions: Depressive Disorder, Major
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 658 participants (actual)
Lead sponsor: Naurex, Inc, an affiliate of Allergan plcIndustry (pharma, biotech, devices)
Study start: 1 Nov 2016 (actual)
Primary completion: 12 Dec 2018 (actual)
Study completion: 18 Dec 2018 (actual)
First posted: 24 Oct 2016 (estimated)
Results: Posted 27 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Rapastinel 225 mg	Experimental	Drug: RapastinelRapastinel 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.
Rapastinel 450 mg	Experimental	Drug: RapastinelRapastinel 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.
Placebo	Placebo comparator	Drug: PlaceboPlacebo-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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (10 listed)

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:
Significant suicide risk, as judged by the Investigator.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RapastinelRapastinel pre-filled syringes for weekly IV injections.	Drug	Rapastinel 225 mg, Rapastinel 450 mg
PlaceboPlacebo-matching rapastinel pre-filled syringes for weekly IV injections.	Drug	Placebo

Primary outcome

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.

1 secondary outcome

Change From Baseline in MADRS Total Score
Time frame: Baseline and Day 8

Results and safety

Results posted to the registry on 27 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	217	207
Rapastinel 225 mg	211	198
Rapastinel 450 mg	210	201

Primary outcome: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Study

Time frame: Baseline and 3 Weeks. Least squares mean (Standard Error). Unit: Score on a Scale

Measure	Placebo n = 217	Rapastinel 225 mg n = 211	Rapastinel 450 mg n = 210
Value	-4.9 (0.59)	-4.8 (0.60)	-5.4 (0.60)

Placebo vs Rapastinel 225 mg: Least Squares Mean Difference: 0.1 (95% CI -1.50 to 1.73), p = 0.8862, Mixed Model Repeated Measures (MMRM)
Rapastinel 225 mg vs Rapastinel 450 mg: Least Squares Mean Difference: -0.5 (95% CI -2.07 to 1.16), p = 0.5772, Mixed Model Repeated Measures (MMRM)

Population analysed: The modified Intent-to-Treat (mITT) Population will consist of all patients who were randomized, received at least 1 dose of IP during the randomized treatment period, and had at least 1 post-randomization assessment of the MADRS total score

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse Events were collected for up to 28 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 217 (0.5%)	14 of 217 (6.5%)	0 of 217
Rapastinel 225 mg	1 of 211 (0.5%)	11 of 211 (5.2%)	0 of 211
Rapastinel 450 mg	1 of 210 (0.5%)	14 of 210 (6.7%)	0 of 210

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jenna Hoogerheyde study director

Allergan

66 sites in 1 country: see every site and its status.

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 66 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 27 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 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. Some participants in this study may receive a placebo. 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 27 Dec 2019). 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?

Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Study (time frame: Baseline and 3 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 NCT02943564.

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 27 Dec 2019.