Depressive Disorder, MajorPhase 3NCT03560518
Study of Rapastinel as Monotherapy in Patients With MDD
A Phase 3 study testing Rapastinel in people with Depressive Disorder, Major, run by Naurex, Inc, an affiliate of Allergan plc at 40 sites in United States.
Trial summary
The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) and 900 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
- 439 participants
- Where
- 40 sitesUnited States
- Study dates
- 15 Jun 2018to 8 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
40 sites in 1 country.
40 sites in 1 country
United States40 sites
California Pharmaceutical Research Institute, Inc.
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 Inc.
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, LLC
Gaithersburg, Maryland, 20877
Collaborative Neuroscience Network
Garden Grove, California, 92845
Research Centers of America, LLC
Hollywood, Florida, 33024
Clinical Neuroscience Solutions, 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, LLC
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
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 450 milligrams (mg) and 900 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 group | Role | What they receive |
|---|---|---|
| Rapastinel 450mg | Experimental | Rapastinel 450 mg (prefilled syringe, weekly intravenous IV administration) Receives: Drug: Rapastinel |
| Rapastinel 900mg | Experimental | Rapastinel 900 mg (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 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 Day 1 Post-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 Day 1 post-first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start15 Jun 2018
- Primary completion8 Jul 2019
- Study completion8 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
- 439 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naurex, Inc, an affiliate of Allergan plc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jenna Hoogerheyde, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560518
- Sponsor's protocol ID
- RAP-MD-32
- Status last verified
- Aug 2020
- First submitted
- 7 Jun 2018
- Last updated
- 1 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 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
- NCT03560518
- Acronym / sponsor ID
- RAP-MD-32
- Conditions
- Depressive Disorder, Major
- Keywords
- Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision to stop the program.
- Enrolment
- 439 participants (actual)
- Lead sponsor
- Naurex, Inc, an affiliate of Allergan plcIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 8 Jul 2019 (actual)
- Study completion
- 8 Jul 2019 (actual)
- First posted
- 18 Jun 2018 (actual)
- Results
- Posted 1 Sep 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 450 milligrams (mg) and 900 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 450 mg (prefilled syringe, weekly intravenous IV administration) |
| Rapastinel 900mg | Experimental | Drug: RapastinelRapastinel 900 mg (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:
- Schizophrenia spectrum or other psychotic disorder
- Bipolar or related disorder
- 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 (prefilled syringe, weekly intravenous IV administration) | Drug | Rapastinel 450mg, Rapastinel 900mg |
| 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 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 Day 1 Post-first Dose of Treatment
Time frame: Baseline to Day 1 post-first dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- 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
40 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 40 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: stopped early, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 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 1 Sep 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 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?
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 1 Sep 2020.