Depressive Disorder, MajorPhase 3NCT03668600

Study of Adjunctive or Monotherapy Rapastinel Treatment in Patients With Major Depressive Disorder (MDD)

A Phase 3 study testing Rapastinel in people with Depressive Disorder, Major, run by Naurex, Inc, an affiliate of Allergan plc at 74 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Multicenter, open-label, long-term extended access treatment protocol in adult patients with a primary diagnosis of MDD. Read more about this study

Who is it for?: Ages 18 to 75 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: 230 participants
Where: 74 sitesUnited States
Study dates: 23 Aug 2018to 3 Jul 2019
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Completion of lead-in study
Adequate therapeutic benefit in the lead-in study to justify continuation of treatment with rapastinel in the judgement of the investigator

Who cannot join

Suicide risk, as determined by meeting any of the following criteria:
A suicide attempt within the past year
Significant risk, as judged by the investigator, based on the psychiatric interview or information collected in the Columbia- Suicide Severity Rating Scale (C-SSRS) at any visit in the lead-in study
Montgomery-Asberg Depression Rating Scale (MADRS) Item 10 score ≥ 5 at any visit during participation in the lead-in study where MADRS was conducted.
At imminent risk of injuring self or others or causing significant damage to property, as judged by the investigator
Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during participation
Females of childbearing potential and male partners of females of childbearing potential, not using a reliable means of contraception

Trial locations and contacts

74 sites in 1 country.

City, postcode or hospital

74 sites in 1 country

United States74 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, 30341
Donald J. Garcia, Jr., MD, PA
Austin, Texas, 78737
Community Clinical Research
Austin, Texas, 78754
Houston Clinical Trials
Bellaire, Texas, 77401
Southern California Research LLC.
Beverly Hills, California, 90036
University of Alabama at Birmingham
Birmingham, Alabama, 35294
SPRI Clinical Trials, LLC
Brooklyn, New York, 11235
Carolina Clinical Trials, Inc.
Charleston, South Carolina, 29407
Psychiatric Alliance of the Blue Ridge, Inc
Charlottesville, Virginia, 22903
Patient Priority Clinical Sites
Cincinnati, Ohio, 45215
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
Midwest Clinical Research Center LLC
Dayton, Ohio, 45417
iResearch Atlanta, LLC
Decatur, Georgia, 30030
Harmonex Neuroscience Research
Dothan, Alabama, 36303
Pharmacology Research Institute
Encino, California, 91316
Precise Research Centers
Flowood, Mississippi, 39232
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912
North Texas Clinical Trials
Fort Worth, Texas, 76104
Behavioral Research Specialists, LLC
Glendale, California, 91206
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
Lake Charles Clinical Trials
Lake Charles, Louisiana, 70629
Meridien Research
Lakeland, Florida, 33805
Innovative Clinical Research, Inc
Lauderhill, Florida, 33319
Synergy Clinical Research Center of Escondido
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
Professional Psychiatric Services
Mason, Ohio, 45040
Research Strategies of Memphis, LLC
Memphis, Tennessee, 38119
ActivMed Practices & Research, Inc.
Methuen, Massachusetts, 01844
Coastal Carolina Research Center
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
Dr. Cherian Verghese
Norristown, Pennsylvania, 19403
Comprehensive Psychiatric Care
Norwich, Connecticut, 06360
Psychiatric Care and Research Center
O'Fallon, Missouri, 63368
Research Centers of America
Oakland Park, Florida, 33334
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
Medical Research Group of Central Florida
Orange City, Florida, 32763
David A. Medina, MD
Orlando, Florida, 32819
NoesisPharma
Phoenix, Arizona, 85016
Summit Research Network LLC
Portland, Oregon, 97210
CITrials
Riverside, California, 92506
Finger Lakes Clinical Research
Rochester, New York, 14618
Woodland Research Northwest
Rogers, Arkansas, 72758
St. Charles Psychiatric Associates
Saint Charles, Missouri, 63304
Psychiatric and Behavioral Solutions
Salt Lake City, Utah, 84105
Clinical Trials of Texas
San Antonio, Texas, 78229
California Neuroscience Research
Sherman Oaks, California, 91403
Louisiana Clinical Research
Shreveport, Louisiana, 71101
Attalla Consultants, LLC
Smyrna, Georgia, 30082
Coastal Research Associates
South Weymouth, Massachusetts, 02190
Richmond Behavioral Associates
Staten Island, New York, 10312
Viking Clinical Research
Temecula, California, 92591
Bio Behavioral Health
Toms River, New Jersey, 08755
Pacific Clinical Research Medical
Upland, California, 91786
University of Kansas School of Medicine Clinical Trial Unit
Wichita, Kansas, 67214
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 Extended Access Protocol for Rapastinel as Adjunctive or Monotherapy Treatment in Patients With Major Depressive Disorder

Multicenter, open-label, long-term extended access treatment protocol in adult patients with a primary diagnosis of MDD.

Conditions: Depressive Disorder, Major
Being tested: Rapastinel
Keywords: Depression
Medical subject headings: Depressive Disorder, Major, Depression

What participants receive

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

RapastinelDrug
Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)

Study groups in NCT03668600
Study group	Role	What they receive
Rapastinel	Experimental	Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration) Receives: Drug: Rapastinel

What is being measured

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

Count of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)
A Treatment Emergent Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.
Measured: Up to 45 Weeks

Timeline

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

23 Aug 20183 Jul 2019

First posted12 Sep 2018
Study start23 Aug 2018
Primary completion3 Jul 2019
Study completion3 Jul 2019

Why it stopped: Business decision to stop the program

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 230 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03668600
Sponsor's protocol ID: RAP-MD-99
Status last verified: Jul 2020
First submitted: 28 Aug 2018
Last updated: 17 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
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 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Long-term Extended Access Protocol for Rapastinel as Adjunctive or Monotherapy Treatment in Patients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT03668600
Acronym / sponsor ID: RAP-MD-99
Conditions: Depressive Disorder, Major
Keywords: Depression
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Business decision to stop the program
Enrolment: 230 participants (actual)
Lead sponsor: Naurex, Inc, an affiliate of Allergan plcIndustry (pharma, biotech, devices)
Study start: 23 Aug 2018 (actual)
Primary completion: 3 Jul 2019 (actual)
Study completion: 3 Jul 2019 (actual)
First posted: 12 Sep 2018 (actual)
Results: Posted 17 Jul 2020

Clinical summary

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

Multicenter, open-label, long-term extended access treatment protocol in adult patients with a primary diagnosis of MDD.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Rapastinel	Experimental	Drug: RapastinelRapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Completion of lead-in study
Adequate therapeutic benefit in the lead-in study to justify continuation of treatment with rapastinel in the judgement of the investigator

Key exclusion criteria (7 listed)

Suicide risk, as determined by meeting any of the following criteria:
At imminent risk of injuring self or others or causing significant damage to property, as judged by the investigator
Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during participation
Females of childbearing potential and male partners of females of childbearing potential, not using a reliable means of contraception

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 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)	Drug	Rapastinel

Primary outcome

Count of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 45 Weeks
A Treatment Emergent Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.

Results and safety

Results posted to the registry on 17 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rapastinel	230	0

Primary outcome: Count of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)

Time frame: Up to 45 Weeks. Number. Unit: Participants

Measure	Rapastinel n = 230
Value	100

Population analysed: The Open-label Safety Population will consist of all participants who signed the RAP-MD-99 ICF and who received at least 1 dose of open-label rapastinel during the OLTP of the protocol.

Adverse events

Time frame: Up to 45 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rapastinel	4 of 230 (1.7%)	14 of 230 (6.1%)	0 of 230

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Depressive Disorder, Major

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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

74 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 74 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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 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 17 Jul 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?

Count of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs) (time frame: Up to 45 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 NCT03668600.

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 17 Jul 2020.