Major Depressive DisorderPhase 3PARADIGMNCT06360419
Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol
A Phase 3 study testing Solriamfetol 300 mg in people with Major Depressive Disorder, run by Axsome Therapeutics, Inc. at 40 sites in United States.
Trial summary
PARADIGM (Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the safety and efficacy of solriamfetol for the treatment of major depressive disorder (MDD) in adults. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Solriamfetol 300 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 346 participants
- Where
- 40 sitesUnited States
- Study dates
- 18 Mar 2024to 26 Mar 2025
- 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 the DSM-5 criteria for MDD without psychotic features, based on the SCID-5-CT
- Current major depressive episode
- Male or female, aged 18 to 65 inclusive
Who cannot join
- Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription
- Unable to comply with study procedures
- Medically inappropriate for study participation in the opinion of the investigator
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
Clinical Research Site
Austin, Texas, 78737
Clinical Research Site
Bellflower, California, 90706
Clinical Research Site
Boston, Massachusetts, 02131
Clinical Research Site
Brandon, Florida, 33511
Clinical Research Site
Brooklyn, New York, 11235
Clinical Research Site
Chicago, Illinois, 60634
Clinical Research Site
Cincinnati, Ohio, 45215
Clinical Research Site
Cromwell, Connecticut, 06416
Clinical Research Site
Dallas, Texas, 75231
Clinical Research Site
Encino, California, 91316
Clinical Research Site
Everett, Washington, 98201
Clinical Research Site
Friendswood, Texas, 77546
Clinical Research Site
Hialeah, Florida, 33012
Clinical Research Site
Hickory, North Carolina, 28601
Clinical Research Site
Jacksonville, Florida, 32256
Clinical Research Site
Las Vegas, Nevada, 89102
Clinical Research Site
Lemon Grove, California, 91945
Clinical Research Site
Little Rock, Arkansas, 72211
Clinical Research Site
Los Angeles, California, 90015
Clinical Research Site
Media, Pennsylvania, 19063
Clinical Research Site
Memphis, Tennessee, 38119
Clinical Research Site
Montclair, California, 91763
Clinical Research Site
New Orleans, Louisiana, 70115
Clinical Research Site
Oceanside, California, 92056
Clinical Research Site
Oklahoma City, Oklahoma, 73116
Clinical Research Site
Orlando, Florida, 32801
Clinical Research Site
Orlando, Florida, 32806
Clinical Research Site
Orlando, Florida, 32807
Clinical Research Site
Overland Park, Kansas, 66210
Clinical Research Site
Philadelphia, Pennsylvania, 19104
Clinical Research Site
Redlands, California, 92374
Clinical Research Site
Riverside, California, 92506
Clinical Research Site
Rochester, New York, 14609
Clinical Research Site
Saint Charles, Missouri, 63304
Clinical Research Site
Sherman Oaks, California, 91403
Clinical Research Site
Staten Island, New York, 10314
Clinical Research Site
Torrance, California, 90501
Clinical Research Site
Upland, California, 91786
Clinical Research Site
Walnut Creek, California, 94596
Clinical Research Site
Wichita Falls, Texas, 76309
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of Solriamfetol in Subjects With Major Depressive Disorder
PARADIGM (Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the safety and efficacy of solriamfetol for the treatment of major depressive disorder (MDD) in adults.
Read the detailed description
Eligible subjects must have a primary diagnosis of MDD without psychotic features based on the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1 ratio to receive either solriamfetol (300 mg) or placebo for 6 weeks.
- Conditions
- Major Depressive Disorder
- Being tested
- Solriamfetol 300 mg, Placebo
- Keywords
- Solriamfetol, Sunosi, MDD, Major Depressive Disorder, Axsome, Non-stimulant therapy, Dopamine norepinephrine reuptake inhibitor, Trace amine-associated receptor 1 (TAAR1) agonist
- 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.
Solriamfetol 300 mgDrug
Solriamfetol tablets, taken once daily
PlaceboDrug
Placebo tablets, taken once daily
| Study group | Role | What they receive |
|---|---|---|
| Solriamfetol 300 mg | Experimental | Up to 6 weeks Receives: Drug: Solriamfetol 300 mg |
| Placebo | Placebo comparator | Up to 6 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Åsberg Depression Rating Scale (MADRS)
Measured: 6 weeks
Incidence of treatment-emergent adverse events
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start18 Mar 2024
- Primary completion31 Dec 2024
- Study completion26 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 346 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
- NCT06360419
- Sponsor's protocol ID
- SOL-MDD-301
- Acronym
- PARADIGM
- Status last verified
- Dec 2025
- First submitted
- 8 Apr 2024
- Last updated
- 5 Jan 2026
- 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 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial of Solriamfetol in Subjects With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT06360419
- Acronym / sponsor ID
- PARADIGM / SOL-MDD-301
- Conditions
- Major Depressive Disorder
- Keywords
- Solriamfetol, Sunosi, MDD, Major Depressive Disorder, Axsome, Non-stimulant therapy, Dopamine norepinephrine reuptake inhibitor, Trace amine-associated receptor 1 (TAAR1) agonist
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- Axsome Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 11 Apr 2024 (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.
PARADIGM (Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the safety and efficacy of solriamfetol for the treatment of major depressive disorder (MDD) in adults.
Detailed description
Eligible subjects must have a primary diagnosis of MDD without psychotic features based on the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1 ratio to receive either solriamfetol (300 mg) or placebo for 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Solriamfetol 300 mg | Experimental | Drug: Solriamfetol 300 mgUp to 6 weeks |
| Placebo | Placebo comparator | Drug: PlaceboUp to 6 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Currently meets the DSM-5 criteria for MDD without psychotic features, based on the SCID-5-CT
- Current major depressive episode
- Male or female, aged 18 to 65 inclusive
Key exclusion criteria (3 listed)
- Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription
- Unable to comply with study procedures
- Medically inappropriate for study participation in the opinion of 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 |
|---|---|---|
| Solriamfetol 300 mgSolriamfetol tablets, taken once daily | Drug | Solriamfetol 300 mg |
| PlaceboPlacebo tablets, taken once daily | Drug | Placebo |
Primary outcome
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 6 weeks
Incidence of treatment-emergent adverse events
Time frame: 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 5 Jan 2026.
- 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.
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 Solriamfetol 300 mg in people with Major Depressive Disorder, run by Axsome Therapeutics, Inc. 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 3 inclusion and 3 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 5 Jan 2026. 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?
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) (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 5 Jan 2026; AzTrials last refreshed its copy on 30 Oct 2026.