Treatment Resistant DepressionPhase 2MERITNCT04608396
Mechanistic Evaluation of Response in TRD (MERIT)
A Phase 2 study testing AXS-05 in people with Treatment Resistant Depression and Major Depressive Disorder, run by Axsome Therapeutics, Inc. at 20 sites in United States.
Trial summary
To evaluate the relapse prevention of AXS-05 relative to placebo in subjects with treatment resistant depression (TRD). This is a randomized, double-blind, placebo-controlled study to evaluate AXS-05 compared to placebo in delaying relapse of depressive symptoms in patients with TRD who are in stable remission after… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment Resistant Depression, Major Depressive Disorder
- What is being tested?
- AXS-05
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 20 sitesUnited States
- Study dates
- 13 Aug 2020to 30 Jul 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Key Eligibility Criteria:
- Ongoing symptoms of depression despite receiving treatment with two or more prior antidepressants during the current major depressive episode, prior to receiving AXS-05
- Agree to use adequate method of contraception for the duration of the study
- Additional criteria may apply
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Clinical Research Site
Berlin, New Jersey, 08009
Clinical Research Site
Boston, Massachusetts, 02131
Clinical Research Site
Chicago, Illinois, 606346
Clinical Research Site
Cincinnati, Ohio, 45215
Clinical Research Site
Dallas, Texas, 75243
Clinical Research Site
Everett, Washington, 98201
Clinical Research Site
Hickory, North Carolina, 28601
Clinical Research Site
Houston, Texas, 77058
Clinical Research Site
Little Rock, Arkansas, 72209
Clinical Research Site
Media, Pennsylvania, 19063
Clinical Research Site
Miami, Florida, 33122
Clinical Research Site
Middleburg Heights, Ohio, 44130
Clinical Research Site
North Miami, Florida, 33161
Clinical Research Site
Orlando, Florida, 32801
Clinical Research Site
Raleigh, North Carolina, 27609
Clinical Research Site
Redlands, California, 92374
Clinical Research Site
Rochester, New York, 14618
Clinical Research Site
Sherman Oaks, California, 91403
Clinical Research Site
Staten Island, New York, 10312
Clinical Research Site
Upland, California, 91786
About this study
Official title: MERIT: A Randomized, Double-blind, Placebo-controlled Study of AXS-05 for Relapse Prevention in Treatment Resistant Depression
To evaluate the relapse prevention of AXS-05 relative to placebo in subjects with treatment resistant depression (TRD).
This is a randomized, double-blind, placebo-controlled study to evaluate AXS-05 compared to placebo in delaying relapse of depressive symptoms in patients with TRD who are in stable remission after treatment with AXS-05.
- Being tested
- AXS-05, Placebo
- Keywords
- AXS-05, Treatment Resistant Depression, TRD, NMDA receptor, Refractory depression, Resistant depression, Depression, Major depression, Relapse prevention, Dextromethorphan, Bupropion
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AXS-05Drug
AXS-05 taken daily for up to 52 weeks, until relapse.
PlaceboDrug
Placebo taken daily for up to 52 weeks, until relapse.
| Study group | Role | What they receive |
|---|---|---|
| AXS-05 | Experimental | Not described Receives: Drug: AXS-05 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse
Assessed by clinician-rated scales.
Measured: Time from randomization to first relapse (up to 52 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start13 Aug 2020
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- More trials run by Axsome Therapeutics, Inc.The sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Axsome Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608396
- Sponsor's protocol ID
- AXS-05-TRD-201
- Acronym
- MERIT
- Status last verified
- Jul 2022
- First submitted
- 7 Oct 2020
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MERIT: A Randomized, Double-blind, Placebo-controlled Study of AXS-05 for Relapse Prevention in Treatment Resistant Depression
- ClinicalTrials.gov ID
- NCT04608396
- Acronym / sponsor ID
- MERIT / AXS-05-TRD-201
- Keywords
- AXS-05, Treatment Resistant Depression, TRD, NMDA receptor, Refractory depression, Resistant depression, Depression, Major depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Axsome Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the relapse prevention of AXS-05 relative to placebo in subjects with treatment resistant depression (TRD).
This is a randomized, double-blind, placebo-controlled study to evaluate AXS-05 compared to placebo in delaying relapse of depressive symptoms in patients with TRD who are in stable remission after treatment with AXS-05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AXS-05 | Experimental | Drug: AXS-05 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| AXS-05AXS-05 taken daily for up to 52 weeks, until relapse. | Drug | AXS-05 |
| PlaceboPlacebo taken daily for up to 52 weeks, until relapse. | Drug | Placebo |
Primary outcome
Relapse
Time frame: Time from randomization to first relapse (up to 52 weeks)
Assessed by clinician-rated scales.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Axsome Therapeutics WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
20 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 AXS-05 in people with Treatment Resistant Depression and Major Depressive Disorder, run by Axsome Therapeutics, Inc. at 20 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?
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 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relapse (time frame: Time from randomization to first relapse (up to 52 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 12 Jul 2022.