Treatment Resistant Major Depressive DisorderPhase 3STRIDE-1NCT02741791
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder
A Phase 3 study testing AXS-05 and Bupropion in people with Treatment Resistant Major Depressive Disorder, run by Axsome Therapeutics, Inc. at 74 sites in United States.
Trial summary
To evaluate the efficacy and safety of AXS-05 relative to bupropion in subjects with treatment resistant major depressive disorder (MDD). This is a randomized, double-blind, active-controlled, 12-week, two-period study consisting of an open-label, bupropion lead-in period, and a double-blind treatment period. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment Resistant Major Depressive Disorder
- What is being tested?
- AXS-05 and Bupropion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 74 sitesUnited States
- Study dates
- Mar 2016to 20 Mar 2020
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently meets DSM-V criteria for MDD
- History of inadequate response to 1 or 2 adequate antidepressant treatments
- Body mass index (BMI) between 18 and 40 kg/m2, inclusive
- Agree to use adequate method of contraception for the duration of the study
- Additional criteria may apply
Who cannot join
- Suicide risk
- Treatment with any investigational drug within 6 months
- History of electroconvulsive therapy (ECT), vagus nerve stimulation, transcranial magnetic stimulation, or any experimental central nervous system treatment during the current episode or in the past 6 months
- Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
- Additional criteria may apply
Trial locations and contacts
74 sites in 1 country.
74 sites in 1 country
United States74 sites
Study site
Albuquerque, New Mexico
Study site
Allentown, Pennsylvania
Study site
Anaheim, California
Study site
Atlanta, Georgia, 30328
Study site
Austin, Texas
Study site
Baltimore, Maryland
Study site
Bellevue, Washington
Study site
Berlin, New Jersey
Study site
Beverly Hills, California
Study site
Boise, Idaho
Study site
Brooklyn, New York
Study site
Canton, Ohio
Study site
Charleston, South Carolina
Study site
Charlotte, North Carolina
Study site
Charlottesville, Virginia
Study site
Cherry Hill, New Jersey
Study site
Colorado Springs, Colorado
Study site
Coral Springs, Florida
Study site
Cromwell, Connecticut
Study site
Dallas, Texas
Study site
Dayton, Ohio
Study site
Fort Lauderdale, Florida
Study site
Fort Myers, Florida
Study site
Gainesville, Florida
Study site
Garden Grove, California
Study site
Herndon, Virginia
Study site
Houston, Texas
Study site
Jacksonville, Florida, 32256
Study site
Jamaica, New York, 11432
Study site
Lakeland, Florida
Study site
Las Vegas, Nevada
Study site
Lincoln, Nebraska
Study site
Lincoln, Rhode Island
Study site
Little Rock, Arkansas
Study site
Marlton, New Jersey
Study site
Media, Pennsylvania
Study site
Memphis, Tennessee, 38119
Study site
Middleburg Heights, Ohio
Study site
Nashua, New Hampshire
Study site
New York, New York
Study site
North Miami, Florida
Study site
Oakland, California
Study site
Oceanside, California
Study site
Oklahoma City, Oklahoma
Study site
Orem, Utah
Study site
Orlando, Florida
Study site
Panorama City, California
Study site
Pensacola, Florida
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Portland, Oregon
Study site
Princeton, New Jersey
Study site
Redlands, California
Study site
Riverside, California
Study site
Rochester, New York
Study site
Saint Charles, Missouri
Study site
Salem, Oregon
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
San Francisco, California
Study site
Seattle, Washington
Study site
Sherman Oaks, California
Study site
Shreveport, Louisiana
Study site
Skokie, Illinois
Study site
Spokane, Washington
Study site
St Louis, Missouri
Study site
St. Petersburg, Florida
Study site
Staten Island, New York
Study site
Temecula, California
Study site
Toms River, New Jersey
Study site
Upland, California
Study site
Washington D.C., District of Columbia, 20016
Study site
Waukesha, Wisconsin
Study site
Wichita Falls, Texas
About this study
Official title: STRIDE-1: A Randomized, Double-blind, Active-controlled Trial to Assess the Efficacy and Safety of AXS-05 Administered Orally to Subjects With Treatment Resistant Major Depressive Disorder
To evaluate the efficacy and safety of AXS-05 relative to bupropion in subjects with treatment resistant major depressive disorder (MDD).
This is a randomized, double-blind, active-controlled, 12-week, two-period study consisting of an open-label, bupropion lead-in period, and a double-blind treatment period. The trial is being conducted in subjects with treatment resistant MDD.
Subjects will be considered to have treatment resistant MDD if they have had a historical inadequate response to 1 or 2 antidepressant treatments and a prospective inadequate response to treatment with bupropion during the open-label, lead-in period.
- Being tested
- AXS-05, Bupropion
- Keywords
- AXS-05, Major Depressive Disorder, Treatment Resistant Depression, TRD, MDD, Axsome, NMDA receptor, Refractory depression, Resistant depression, Depression
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant, 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 6 weeks.
BupropionDrug
Buproprion taken daily for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| AXS-05 | Experimental | Not described Receives: Drug: AXS-05 |
| Bupropion | Active comparator | Not described Receives: Drug: Bupropion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Åsberg Depression Rating Scale (MADRS) total score
The MADRS is used to assess depressive symptomatology during the previous week. Subjects are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity.
Measured: MADRS change from Baseline to End of Study (6 weeks)
Secondary outcomes (2)
Clinical Global Impressions-Severity (CGI-S)
Measured: Baseline to End of Study (6 weeks)
Hamilton Depression Rating Scale - 17 items (HAMD-17)
Measured: Baseline to End of Study (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startMar 2016
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant Major Depressive DisorderStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 312 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
- NCT02741791
- Sponsor's protocol ID
- AXS-05-301
- Acronym
- STRIDE-1
- Status last verified
- Mar 2021
- First submitted
- 5 Apr 2016
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STRIDE-1: A Randomized, Double-blind, Active-controlled Trial to Assess the Efficacy and Safety of AXS-05 Administered Orally to Subjects With Treatment Resistant Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT02741791
- Acronym / sponsor ID
- STRIDE-1 / AXS-05-301
- Keywords
- AXS-05, Major Depressive Disorder, Treatment Resistant Depression, TRD, MDD, Axsome, NMDA receptor, Refractory depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Axsome Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 18 Apr 2016 (estimated)
- 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 efficacy and safety of AXS-05 relative to bupropion in subjects with treatment resistant major depressive disorder (MDD).
This is a randomized, double-blind, active-controlled, 12-week, two-period study consisting of an open-label, bupropion lead-in period, and a double-blind treatment period. The trial is being conducted in subjects with treatment resistant MDD.
Subjects will be considered to have treatment resistant MDD if they have had a historical inadequate response to 1 or 2 antidepressant treatments and a prospective inadequate response to treatment with bupropion during the open-label, lead-in period.
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 |
| Bupropion | Active comparator | Drug: Bupropion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Currently meets DSM-V criteria for MDD
- History of inadequate response to 1 or 2 adequate antidepressant treatments
- Body mass index (BMI) between 18 and 40 kg/m2, inclusive
- Agree to use adequate method of contraception for the duration of the study
- Additional criteria may apply
Key exclusion criteria (5 listed)
- Suicide risk
- Treatment with any investigational drug within 6 months
- History of electroconvulsive therapy (ECT), vagus nerve stimulation, transcranial magnetic stimulation, or any experimental central nervous system treatment during the current episode or in the past 6 months
- Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
- Additional criteria may apply
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 6 weeks. | Drug | AXS-05 |
| BupropionBuproprion taken daily for 6 weeks. | Drug | Bupropion |
Primary outcome
Montgomery-Åsberg Depression Rating Scale (MADRS) total score
Time frame: MADRS change from Baseline to End of Study (6 weeks)
The MADRS is used to assess depressive symptomatology during the previous week. Subjects are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity.
2 secondary outcomes
Clinical Global Impressions-Severity (CGI-S)
Time frame: Baseline to End of Study (6 weeks)
Hamilton Depression Rating Scale - 17 items (HAMD-17)
Time frame: Baseline to End of Study (6 weeks)
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 24 Mar 2021.
- www.TRDstudy.comLink 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.
74 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 AXS-05 and Bupropion in people with Treatment Resistant Major Depressive Disorder, run by Axsome Therapeutics, Inc. at 74 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 5 inclusion and 5 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 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 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. 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?
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?
Montgomery-Åsberg Depression Rating Scale (MADRS) total score (time frame: MADRS change from Baseline to End of Study (6 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 24 Mar 2021.