Depressive Disorder, MajorPhase 3NCT02943577
A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-03)
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
This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 milligrams (mg) compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT. 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
- 429 participants
- Where
- 40 sitesUnited States
- Study dates
- 2 Nov 2016to 21 Nov 2018
- 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 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 8 weeks and not exceeding 18 months in duration at Visit 1
- Have no more than partial response (< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant
- 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
Albuquerque Neuroscience, Inc
Albuquerque, New Mexico, 87109
Sheppard Pratt Health System
Baltimore, Maryland, 21204
Houston Clinical Trials, LLC
Bellaire, Texas, 77401
Hassman Research Institute, LLC
Berlin, New Jersey, 08009
SPRI Clinical Trials, Inc
Brooklyn, New York, 11235
New Hope Clinical Research Inc.
Charlotte, North Carolina, 28211
Department of Psychiatry and Neurobehavioral Sciences, University of Virginia
Charlottesville, Virginia, 22903
Psychiatric Alliance of the Blue Ridge, Inc.
Charlottesville, Virginia, 22903
MCB Clinical Research Center
Colorado Springs, Colorado, 80910
Harmonex Neuroscience Research
Dothan, Alabama, 36303
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912
North Texas Clinical Trials
Fort Worth, Texas, 76104
Research Centers of America
Hollywood, Florida, 33024
Sun Valley Research Center
Imperial, California, 92251
Irvine Center for Clinical Research, Inc
Irvine, California, 92614
Alivation Research
Lincoln, Nebraska, 68526
Northwest Behavioral Research Center
Marietta, Georgia, 30060
Research Strategies of Memphis, LLC
Memphis, Tennessee, 38119
Innova Clinical Trials Inc.
Miami, Florida, 33133
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, 10036
Fieve Clinical Research
New York, New York, 10168
Dr. Cherian Verghese
Norristown, Pennsylvania, 20006
Psychiatric Care and Research Center
O'Fallon, Missouri, 63368
NRC Research Institute
Orange, California, 92868
Combined Research Orlando Phase I-IV
Orlando, Florida, 32807
Psychiatric Associates
Overland Park, Kansas, 66211
Asclepes Research Centers
Panorama City, California, 91402
NoesisPharma
Phoenix, Arizona, 85016
Global Medical Institute, LLC
Princeton, New Jersey, 08540
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, 63304
Psychiatric and Behavioral Solutions
Salt Lake City, Utah, 84105
Artemis Institute for Clinical Research
San Marcos, California, 92078
Louisiana Clinical Research
Shreveport, Louisiana, 71101
Olympian Clinical Research
Tampa, Florida, 33609
The University of South Florida Board of Trustees, A public Body Corporate, for University of South Florida
Tampa, Florida, 33613
Bio Behavioral Health
Toms River, New Jersey, 08755
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder
This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 milligrams (mg) compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.
- 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 group | Role | What they receive |
|---|---|---|
| Rapastinel 450 mg | Experimental | Rapastinel 450 mg weekly intravenous (IV) injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment. Receives: Drug: Rapastinel |
| Placebo | Placebo comparator | Placebo-matching rapastinel weekly IV injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment. 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 at the End of Study
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 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 3 Weeks
Secondary outcomes (3)
Change From Baseline in 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 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 Day 8
Change From Baseline to Day 21 in MADRS Total Score for the Placebo Non-responders of mITT Population
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 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 Day 21
Change From Baseline to Day 8 in MADRS Total Score for the Placebo Non-responders of mITT Population
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 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 Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study start2 Nov 2016
- Primary completion26 Oct 2018
- Study completion21 Nov 2018
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 429 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
- NCT02943577
- Sponsor's protocol ID
- RAP-MD-03
- Status last verified
- Oct 2019
- First submitted
- 21 Oct 2016
- Last updated
- 13 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. 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 Adjunctive Therapy in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT02943577
- Acronym / sponsor ID
- RAP-MD-03
- Conditions
- Depressive Disorder, Major
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 429 participants (actual)
- Lead sponsor
- Naurex, Inc, an affiliate of Allergan plcIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2016 (actual)
- Primary completion
- 26 Oct 2018 (actual)
- Study completion
- 21 Nov 2018 (actual)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Posted 13 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 milligrams (mg) compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.
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 450 mg | Experimental | Drug: RapastinelRapastinel 450 mg weekly intravenous (IV) injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo-matching rapastinel weekly IV injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment. |
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 8 weeks and not exceeding 18 months in duration at Visit 1
- Have no more than partial response (< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant
- 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 pre-filled syringes for weekly IV injections. | Drug | Rapastinel 450 mg |
| 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 at the End of Study
Time frame: Baseline and 3 Weeks
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 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.
3 secondary outcomes
Change From Baseline in MADRS Total Score
Time frame: Baseline and Day 8
Change From Baseline to Day 21 in MADRS Total Score for the Placebo Non-responders of mITT Population
Time frame: Baseline and Day 21
Change From Baseline to Day 8 in MADRS Total Score for the Placebo Non-responders of mITT Population
Time frame: Baseline and Day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- 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: finished, as of the sponsor's last update on 13 Nov 2019. 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 13 Nov 2019). 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 at the End of Study (time frame: Baseline and 3 Weeks). 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 13 Nov 2019.