Depressive Disorder, MajorPhase 3NCT03675776

Study of Rapastinel as Monotherapy 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 23 sites in 5 countries.

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 225 milligrams (mg) and 450 milligrams (mg) of Rapastinel, compared to placebo 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: 50 participants
Where: 23 sitesin 5 countries
Study dates: 30 Oct 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

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
Treatment naive in the current episode or have inadequate response to 1-3 antidepressant therapies given at adequate dose and duration in the current episode
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

23 sites in 5 countries.

Country

City, postcode or hospital

23 sites in 5 countries

Japan15 sites

Himorogi Psychiatric Institute
Ichigayatamachi, 162-0843
Kishiro Mental Clinic
Kawasaki-shi, 214-0014
Tatsuta Clinic
Kobe, 651-0097
Medical corporation Sato-Kai Yuge Hospital
Kumamoto, 861-8002
Sagaarashiyama-Tanaka Clinic
Kyoto, 616-8421
Senzoku psychosomatic Medicine Clinic
Meguro-ku, 152-0012
Higashi Sapporo Mental Clinic
Sapporo, 003-0003
Sangenjaya Neurology- Psychosomatic Clinic
Setagaya-ku, 154-0004
Yoyogi Mental Clinic
Shibuya-ku, 151-0051
Maynds Tower Mental Clinic
Shibuya-ku, 151-0053
Himeno Tomomi Clinic
Shinagawa-ku, 141-0032
Shinjuku Research Park Clinic
Shinjuku-ku, 169-0073
Ohwa Mental Clinic
Toshima-ku, 170-0002
Okehazama Hospital Fujita Kokoro Care Center
Toyoake, 470-1168
Yokohama Onoecho Clinic
Yokohama, 231-0015

Other trials in Japan

Slovakia4 sites

MENTUM, s.r.o.
Bratislava, 82007
Vavrusova Consulting s.r.o. Neštátna Psychiatrická ambulancia
Bratislava, 85101
Liptovská nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovský Mikuláš
Liptovský Mikuláš, 03123
Psycholine s.r.o.
Rimavská Sobota, 97901

Other trials in Slovakia

Russia2 sites

Federal State Budgetary Research Institution "Mental Health Science Center"
Moscow, 115522
Yaroslavl Regional Psychiatric Hospital
Yaroslavl, 150003

Other trials in Russia

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, Multicenter Study of Rapastinel as Monotherapy in Patients With Major Depressive Disorder

The study will evaluate the efficacy, safety, and tolerability of 225 milligrams (mg) and 450 milligrams (mg) of Rapastinel, compared to placebo in participants with major depressive disorder (MDD).

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 (prefilled syringe, weekly intravenous IV administration).
PlaceboDrug
Placebo (prefilled syringe, weekly IV administration).

Study groups in NCT03675776
Study group	Role	What they receive
Rapastinel 450mg	Experimental	Rapastinel (prefilled syringe, weekly intravenous IV administration). Receives: Drug: Rapastinel
Rapastinel 225mg	Experimental	Rapastinel (prefilled syringe, weekly intravenous IV administration). Receives: Drug: Rapastinel
Placebo	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.

Change From Baseline on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at End of Double-blind Treatment (End of Week 6).
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 to end of Week 6

Secondary outcomes (1)

Change From Baseline in MADRS Total Score at 1 Day After First Dose of Treatment
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 to 1 Day post-first dose

Timeline

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

30 Oct 201811 Jul 2019

First posted18 Sep 2018
Study start30 Oct 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: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03675776
Sponsor's protocol ID: RAP-MD-30
Other IDs: 2018-000060-29, 2018
Status last verified: Jul 2020
First submitted: 17 Sep 2018
Last updated: 28 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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Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2020. 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 Monotherapy in Patients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT03675776
Acronym / sponsor ID: RAP-MD-30
Conditions: Depressive Disorder, Major
Keywords: Depression
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Business decision to stop the program.
Enrolment: 50 participants (actual)
Lead sponsor: Naurex, Inc, an affiliate of Allergan plcIndustry (pharma, biotech, devices)
Study start: 30 Oct 2018 (actual)
Primary completion: 11 Jul 2019 (actual)
Study completion: 11 Jul 2019 (actual)
First posted: 18 Sep 2018 (actual)
Results: Posted 28 Jul 2020

Clinical summary

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

The study will evaluate the efficacy, safety, and tolerability of 225 milligrams (mg) and 450 milligrams (mg) of Rapastinel, compared to placebo in participants with major depressive disorder (MDD).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Rapastinel 450mg	Experimental	Drug: RapastinelRapastinel (prefilled syringe, weekly intravenous IV administration).
Rapastinel 225mg	Experimental	Drug: RapastinelRapastinel (prefilled syringe, weekly intravenous IV administration).
Placebo	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 (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
Treatment naive in the current episode or have inadequate response to 1-3 antidepressant therapies given at adequate dose and duration in the current episode
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 (prefilled syringe, weekly intravenous IV administration).	Drug	Rapastinel 225mg, Rapastinel 450mg
PlaceboPlacebo (prefilled syringe, weekly IV administration).	Drug	Placebo

Primary outcome

Change From Baseline on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at End of Double-blind Treatment (End of Week 6).
Time frame: Baseline to end of Week 6
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.

1 secondary outcome

Change From Baseline in MADRS Total Score at 1 Day After First Dose of Treatment
Time frame: Baseline to 1 Day post-first dose

Results and safety

Results posted to the registry on 28 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
Placebo	15	9
Rapastinel 225mg	17	11
Rapastinel 450mg	18	10

Primary outcome: Change From Baseline on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at End of Double-blind Treatment (End of Week 6).

Time frame: Baseline to end of Week 6. Mean (Standard Deviation). Unit: Score on a scale

Measure	Placebo n = 15	Rapastinel 225mg n = 17	Rapastinel 450mg n = 18
Value	-11.3 (9.06)	-21.3 (10.31)	-12.9 (11.36)

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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 15 (0%)	6 of 15 (40%)	0 of 15
Rapastinel 225mg	0 of 17 (0%)	1 of 17 (5.9%)	0 of 17
Rapastinel 450mg	0 of 18 (0%)	6 of 18 (33.3%)	0 of 18

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 28 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.Link provided by the sponsor.

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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

23 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 23 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 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: stopped early, as of the sponsor's last update on 28 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 23 sites in Japan, Slovakia, Russia, 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 28 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?

Change From Baseline on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at End of Double-blind Treatment (End of Week 6). (time frame: Baseline to end of Week 6). 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 NCT03675776.

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 28 Jul 2020.