Depressive Disorder, MajorPhase 3NCT03614156

Study of Monotherapy Rapastinel in the Prevention of Relapse 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 52 sites in 5 countries.

Terminated

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

Official record

Search all trials

Trial summary

The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) or 225 mg of Rapastinel compared to placebo in the prevention of relapse in participants with major depressive disorder (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?: Yes, some participants may receive a placebo
How many people: 363 participants
Where: 52 sitesin 5 countries
Study dates: 2 Aug 2018to 11 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 Study RAP-MD-30, RAP-MD-31, or RAP-MD-32
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:
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

Show all 10Show fewer

5.Dissociative disorder
6.Posttraumatic stress disorder
7.MDD with psychotic features
Significant suicide risk, as judged by the Investigator

Trial locations and contacts

52 sites in 5 countries.

Country

City, postcode or hospital

52 sites in 5 countries

United States40 sites

California Pharmaceutical Research Institute
Anaheim, California, 92804
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Institute for Advanced Medical Research
Atlanta, Georgia, 30341
Donald J. Garcia, Jr., MD, PA
Austin, Texas, 78737
Pharmasite Research, Inc.
Baltimore, Maryland, 21208
Northwest Clinical Research Center
Bellevue, Washington, 98007
Hassman Research Institute
Berlin, New Jersey, 08009
Boston Clinical Trials
Boston, Massachusetts, 02131
New Hope Clinical Research
Charlotte, North Carolina, 28211
Millennium Psychiatric Associates, LLC
Creve Coeur, Missouri, 63141
Midwest Clinical Research Center
Dayton, Ohio, 45417
iResearch Atlanta, LLC
Decatur, Georgia, 30030
Precise Research Centers
Flowood, Mississippi, 39232
CBH Health
Gaithersburg, Maryland, 20877
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, 60169
Research Centers of America
Hollywood, Florida, 33024
Clinical NeuroscienceSolutions, Inc.
Jacksonville, Florida, 32256
Altea Research Institute
Las Vegas, Nevada, 89102
Innovative Clinical Research, Inc.
Lauderhill, Florida, 33319
Capstone Clinical Research
Libertyville, Illinois, 60048
Woodland International Research Group
Little Rock, Arkansas, 72211
Suburban Research Associates
Media, Pennsylvania, 19063
Innova Clinical Trials
Miami, Florida, 33133
Bioscience Research LLC
Mount Kisco, New York, 10549
Synergy Research San Diego
National City, California, 91950
Icahn School of Medicine at Mount Sinai
New York, New York, 10028
Eastside Comprehensive Medical Center
New York, New York, 10128
The Medical Research Network, LLC
New York, New York, 10128
Keystone Clinical Studies, LLC
Norristown, Pennsylvania, 19403
Excell Research Inc.
Oceanside, California, 92056
IPS Research Company
Oklahoma City, Oklahoma, 73103
NRC Research Institute
Orange, California, 92868
Alea Research
Phoenix, Arizona, 85012
Finger Lakes Clinical Research
Rochester, New York, 14618
Artemis Institute for Clinical Research
San Diego, California, 92103
California Neuroscience Research Medical Group,Inc.
Sherman Oaks, California, 91403
Iris Research, Inc.
Smyrna, Georgia, 30082
Viking Clinical Research Ltd.
Temecula, California, 92591
Pacific Clinical Research Medical Group
Upland, California, 91786
Adams Clinical
Watertown, Massachusetts, 02472

Other trials in United States

Japan6 sites

Medical corporation Sato-Kai Yuge Hospital
Kumamoto, 861-8002
Sagaarashiyama-Tanaka Clinic
Kyoto, 616-8421
Sangenjaya Neurology- Psychosomatic Clinic
Setagaya-ku, 154-0004
Yoyogi Mental Clinic
Shibuya-ku, 151-0051
Maynds Tower Mental Clinic
Shibuya-ku, 151-0053
Ohwa Mental Clinic
Toshima-ku, 170-0002

Other trials in Japan

Slovakia4 sites

VAVRUŠOVÁ CONSULTING s.r.o., Psychiatrická ambulancia
Bratislava, 851 01
MENTUM, s.r.o.
Bratislava Mestská Časť Ružinov, 820 07
Liptovská nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovský Mikuláš
Liptovský Mikuláš, 031 23
PsychoLine s.r.o., Psychiatrická ambulancia
Rimavská Sobota, 979 01

Other trials in Slovakia

Hungary1 site

Bugát Pál Hospital, Clinexpert
Gyöngyös, 3200

Other trials in Hungary

Poland1 site

Centrum Medyczne Luxmed Sp.z o.o.
Lublin, 20-109

Other trials in Poland

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study of Rapastinel in the Prevention of Relapse in Patients With Major Depressive Disorder

Conditions: Depressive Disorder, Major
Being tested: Rapastinel, Placebo
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 or 225 mg (prefilled syringe, weekly intravenous IV administration) or Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)
PlaceboDrug
Placebo (prefilled syringe, weekly IV administration)

Study groups in NCT03614156
Study group	Role	What they receive
Rapastinel weekly	Experimental	Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration) Receives: Drug: Rapastinel
Rapastinel clinically driven schedule	Experimental	Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks) Receives: Drug: Rapastinel
Placebo weekly	Placebo comparator	Placebo (prefilled syringe, weekly IV administration) Receives: Drug: Placebo

What is being measured

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

Time to First Relapse During the 52 Weeks of the Double-Blind Treatment Period (DBTP)
The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.
Measured: 52 Weeks

Timeline

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

2 Aug 201811 Jul 2019

First posted3 Aug 2018
Study start2 Aug 2018
Primary completion11 Jul 2019
Study completion11 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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 363 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03614156
Sponsor's protocol ID: RAP-MD-33
Other IDs: 2018-000064-28, 2018
Status last verified: Sep 2020
First submitted: 30 Jul 2018
Last updated: 9 Oct 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

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)

All Depressive Disorder, Major trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study of Rapastinel in the Prevention of Relapse in Patients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT03614156
Acronym / sponsor ID: RAP-MD-33
Conditions: Depressive Disorder, Major
Keywords: Depression
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Business decision to stop the program.
Enrolment: 363 participants (actual)
Lead sponsor: Naurex, Inc, an affiliate of Allergan plcIndustry (pharma, biotech, devices)
Study start: 2 Aug 2018 (actual)
Primary completion: 11 Jul 2019 (actual)
Study completion: 11 Jul 2019 (actual)
First posted: 3 Aug 2018 (actual)
Results: Posted 9 Oct 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: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Rapastinel weekly	Experimental	Drug: RapastinelRapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration)
Rapastinel clinically driven schedule	Experimental	Drug: RapastinelRapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)
Placebo weekly	Placebo comparator	Drug: PlaceboPlacebo (prefilled syringe, weekly 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 Study RAP-MD-30, RAP-MD-31, or RAP-MD-32
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:
1.Schizophrenia spectrum or other psychotic disorder
2.Bipolar or related disorder
3.Major neurocognitive disorder

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 or 225 mg (prefilled syringe, weekly intravenous IV administration) or Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)	Drug	Rapastinel clinically driven schedule, Rapastinel weekly
PlaceboPlacebo (prefilled syringe, weekly IV administration)	Drug	Placebo weekly

Primary outcome

Time to First Relapse During the 52 Weeks of the Double-Blind Treatment Period (DBTP)
Time frame: 52 Weeks
The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.

Results and safety

Results posted to the registry on 9 Oct 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
Open-Label Treatment Period (OLTP) Weekly Rapastinel	363	209
DBTP Placebo Weekly	0	0
DBTP Rapastinel Clinically Driven Schedule	0	0
DBTP Rapastinel Weekly	0	0

Primary outcome: Time to First Relapse During the 52 Weeks of the Double-Blind Treatment Period (DBTP)

Time frame: 52 Weeks. Median (95% Confidence Interval). Unit: Days

Measure	DBTP Placebo Weekly n = 40	DBTP Rapastinel Clinically Driven Schedule n = 42	DBTP Rapastinel Weekly n = 55
Value	NA (NA to NA)	203 (177 to NA)	NA (NA to NA)

Population analysed: The Double-blind Safety Population consisted of all patients in the Open-label Safety Population who were randomized to a treatment group during the DBTP of the study and received at least 1 dose of double-blind IP.

Adverse events

Time frame: The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Open-Label Treatment Period	4 of 363 (1.1%)	44 of 363 (12.1%)	0 of 363
DBTP Placebo Weekly	1 of 40 (2.5%)	17 of 40 (42.5%)	0 of 40
DBTP Rapastinel Clinically Driven Schedule	1 of 42 (2.4%)	9 of 42 (21.4%)	0 of 42
DBTP Rapastinel Weekly	0 of 55 (0%)	13 of 55 (23.6%)	0 of 55

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 9 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Depressive Disorder, Major

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)

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

52 sites in 5 countries: 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 52 sites in 5 countries.

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 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: stopped early, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States, Japan, Slovakia, Hungary, Poland. 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 9 Oct 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?

Time to First Relapse During the 52 Weeks of the Double-Blind Treatment Period (DBTP) (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 NCT03614156.

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 9 Oct 2020.