Depressive Disorder, MajorPhase 2NCT03352453

A Study of Rapastinel for Rapid Treatment of Depression and Suicidality in Major Depressive Disorder

A Phase 2 study testing Rapastinel in people with Depressive Disorder, Major, run by Naurex, Inc, an affiliate of Allergan plc at 17 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

The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) of Rapastinel, compared to placebo in adult patients with major depressive disorder (MDD) who are at imminent risk of suicide. 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: 138 participants
Where: 17 sitesUnited States
Study dates: 15 Dec 2017to 21 Jun 2019
Phase: Phase 2
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 4 weeks and not exceeding 24 months in duration at visit 1
Have current, ongoing suicidality (ideation or behavior) of sufficient severity to warrant hospitalization based on the judgment of the investigator
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 1 month before Visit 1.
Lifetime history or currently meet 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 11Show fewer

Dissociative disorder
Posttraumatic stress disorder
MDD with psychotic features
Significant homicidal ideation or at imminent risk of injuring others or causing significant damage to property, as judged by the investigator.
Prior participation in any investigational study of rapastinel/GLYX-13

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

Atlanta Center for Medical Research (ACMR)
Atlanta, Georgia, 30331
The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham
Birmingham, Alabama, 35294-0107
Cincinnati VA Medical Center
Cincinnati, Ohio, 45220-2288
CBH Health
Gaithersburg, Maryland, 20877
Collaborative NeuroScience Network, LLC
Garden Grove, California, 92845
Behavioral Research Specialists, LLC
Glendale, California, 91206-4282
Institute of Living
Hartford, Connecticut, 06106
Innovative Clinical Research, Inc
Hialeah, Florida, 33012
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, 60169
Lake Charles Clinical Trials
Lake Charles, Louisiana, 70629
Altea Research Institute
Las Vegas, Nevada, 89102
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Research Centers of America, LLC
Oakland Park, Florida, 33334
Asclepes Research Centers
Panorama City, California, 91402
Pillar Clinical Research, LLC
Richardson, Texas, 75080
Carilion Medical Center, a Virginia Nonprofit Corporation
Roanoke, Virginia, 24014-2419
Department of Veterans Affairs Salem VA Medical Center
Salem, Virginia, 24153

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Efficacy and Safety Study of Rapastinel for Rapid Treatment of Symptoms of Depression and Suicidality in Adult Patients With 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 NCT03352453
Study group	Role	What they receive
Rapastinel 450mg	Experimental	Rapastinel 450 milligram (mg) weekly intravenous (IV) injections. Receives: Drug: Rapastinel
Placebo	Placebo comparator	Placebo-matching rapastinel weekly IV injections. 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
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 a 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 1 Day
Change From Baseline in Sheehan - Suicidality Tracking Scale (S-STS) Total Score
The S-STS is a patient-report informed, clinician-rated scale used to rate the severity of suicidal impulses, thoughts, and behaviors. This is a 14 item scale ranging from 0=Not at all to 4= Extremely. The total score ranges from 0 to 56 with a higher score indicating higher suicidal tendency.
Measured: Baseline and 1 Day

Secondary outcomes (2)

Change From Baseline in Montgomery-Asberg Depression Rating Scale (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 a 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 28 Days
Change From Baseline in Sheehan - Suicidality Tracking Scale (S-STS) Total Score
The S-STS is a patient-report informed, clinician-rated scale used to rate the severity of suicidal impulses, thoughts, and behaviors. This is a 14 item scale ranging from 0=Not at all to 4= Extremely. The total score ranges from 0 to 56 with a higher score indicating higher suicidal tendency.
Measured: Baseline and 28 Days

Timeline

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

15 Dec 201721 Jun 2019

First posted24 Nov 2017
Study start15 Dec 2017
Primary completion21 Jun 2019
Study completion21 Jun 2019

Why it stopped: Study stopped due to business reasons.

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 138 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03352453
Sponsor's protocol ID: RAP-MD-20
Status last verified: Jul 2020
First submitted: 21 Nov 2017
Last updated: 14 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

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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Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Efficacy and Safety Study of Rapastinel for Rapid Treatment of Symptoms of Depression and Suicidality in Adult Patients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT03352453
Acronym / sponsor ID: RAP-MD-20
Conditions: Depressive Disorder, Major
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study stopped due to business reasons.
Enrolment: 138 participants (actual)
Lead sponsor: Naurex, Inc, an affiliate of Allergan plcIndustry (pharma, biotech, devices)
Study start: 15 Dec 2017 (actual)
Primary completion: 21 Jun 2019 (actual)
Study completion: 21 Jun 2019 (actual)
First posted: 24 Nov 2017 (actual)
Results: Posted 14 Aug 2020

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: 2

Arm	Type	Receives
Rapastinel 450mg	Experimental	Drug: RapastinelRapastinel 450 milligram (mg) weekly intravenous (IV) injections.
Placebo	Placebo comparator	Drug: PlaceboPlacebo-matching rapastinel weekly IV injections.

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 4 weeks and not exceeding 24 months in duration at visit 1
Have current, ongoing suicidality (ideation or behavior) of sufficient severity to warrant hospitalization based on the judgment of the investigator
If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test.

Key exclusion criteria (11 listed)

DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 1 month before Visit 1.
Lifetime history or currently meet DSM-5 criteria for:
Significant homicidal ideation or at imminent risk of injuring others or causing significant damage to property, as judged by the investigator.
Prior participation in any investigational study of rapastinel/GLYX-13

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 450mg
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
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 a 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.
Change From Baseline in Sheehan - Suicidality Tracking Scale (S-STS) Total Score
Time frame: Baseline and 1 Day
The S-STS is a patient-report informed, clinician-rated scale used to rate the severity of suicidal impulses, thoughts, and behaviors. This is a 14 item scale ranging from 0=Not at all to 4= Extremely. The total score ranges from 0 to 56 with a higher score indicating higher suicidal tendency.

2 secondary outcomes

Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Time frame: Baseline and 28 Days
Change From Baseline in Sheehan - Suicidality Tracking Scale (S-STS) Total Score
Time frame: Baseline and 28 Days

Results and safety

Results posted to the registry on 14 Aug 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
Placebo	66	44
Rapastinel 450mg	72	40

Primary outcome: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

Time frame: Baseline and 1 Day. Mean (Standard Deviation). Unit: Scores on a scale

Measure	Placebo n = 64	Rapastinel 450mg n = 72
Value	-17.6 (12.49)	-16.3 (11.36)

Population analysed: The modified Intent-to-Treat (mITT) Population consists of all participants in the Safety Population who had at least 1 postbaseline assessment of the MADRS total score or S-STS total score.

Primary outcome: Change From Baseline in Sheehan - Suicidality Tracking Scale (S-STS) Total Score

Time frame: Baseline and 1 Day. Mean (Standard Deviation). Unit: Scores on a scale

Measure	Placebo n = 64	Rapastinel 450mg n = 72
Value	-20.6 (12.27)	-20.2 (11.93)

Population analysed: The modified Intent-to-Treat (mITT) Population consists of all patients in the Safety Population who had at least 1 postbaseline assessment of the MADRS total score or S-STS total score.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: The study consisted of a 4 week double-blind treatment period, followed by a 1-week safety follow-up period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	5 of 64 (7.8%)	18 of 64 (28.1%)	0 of 64
Rapastinel 450mg	12 of 72 (16.7%)	21 of 72 (29.2%)	0 of 72

Limitations and caveats (from the sponsor): Due to study termination, the target number of participants needed to achieve target power and statistically reliable results was not met.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rapastinel in people with Depressive Disorder, Major, run by Naurex, Inc, an affiliate of Allergan plc at 17 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 11 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 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 14 Aug 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?

Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (time frame: Baseline and 1 Day). The study lists 2 primary outcomes in all. 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 NCT03352453.

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 14 Aug 2020.