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Major Depressive DisorderPhase 3NCT06029439

Study to Assess the Safety and Effectiveness of NMRA-335140-501

A Phase 3 study testing NMRA-335140 in people with Major Depressive Disorder, run by Neumora Therapeutics, Inc. at 178 sites in 11 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a 52-week open-label extension (OLE) study that will evaluate the safety, tolerability, and effectiveness of NMRA-335140 in participants with major depressive disorder (MDD). 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?
NMRA-335140
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
904 participants
Where
178 sitesin 11 countries
Study dates
10 Nov 2023to 17 Aug 2026
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

  • Rollover participants are eligible for the study if the following inclusion criteria are met:
  • Completed a previous NMRA-335140 Phase 3 MDD study (example: NMRA-335140-301, NMRA-335140-302, or NMRA-335140-303) according to the completion definition in the parent study protocol.
  • Signed an informed consent form (ICF) for this study.
  • Willing to comply with the contraception requirements described in the inclusion criteria of the parent study protocol.
  • Willing to comply with the concomitant medication/therapy restrictions described in the exclusion criteria of the parent study protocol.

Who cannot join

  • Rollover participants are excluded from the study if any of the following exclusion criteria are met:
  • Diagnosed with another Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) disorder that would have been exclusionary in the parent study (eg, personality disorder, bipolar 1 or 2, schizophrenia, any other psychotic disorder, or moderate or severe substance or alcohol use disorder [excluding nicotine]).
  • Considered to be at significant risk of suicide in the judgment of the Investigator. This includes participants who are actively suicidal (eg, any suicide attempts during the parent study) or are at serious suicidal risk as indicated by any current suicidal intent, including a plan, as assessed by the C-SSRS ("Since Last Visit" version, score of "YES" on suicidal ideation Item 4 or 5) and/or based on clinical evaluation by the Investigator; or are homicidal, in the opinion of the Investigator.
  • Non-adherent with study medication (took ≤70% of study drug over any 2-week visit interval) or procedures during the parent study.
  • Experienced treatment emergent adverse events (TEAEs) considered related to the study medication from the parent study and judged by the Investigator to be clinically significant to render the participant ineligible for enrollment.
  • Have an abnormality on ocular examination that would prohibit continued study participation as determined by the Investigator.
  • Use of disallowed concomitant medication or therapy that would have been exclusionary in the parent study, may compromise the safety of the participant, and/or confound the interpretation of protocol assessments.
  • Considered by the Investigator to be inappropriate for any other reason.

Trial locations and contacts

178 sites in 11 countries.

178 sites in 11 countries

United States126 sites

  • Neumora Investigator Site

    Albuquerque, New Mexico, 87109

  • Neumora Investigator Site

    Allentown, Pennsylvania, 18104

  • Neumora Investigator Site

    Atlanta, Georgia, 30318

  • Neumora Investigator Site #1

    Atlanta, Georgia, 30328

  • Neumora Investigator Site

    Atlanta, Georgia, 30328

  • Neumora Investigator Site

    Atlanta, Georgia, 30338

  • Neumora Investigator Site

    Austin, Texas, 78737

  • Neumora Investigator site

    Austin, Texas, 78759

  • Neumora Investigator Site

    Baltimore, Maryland, 21208

  • Neumora Investigator Site

    Bellevue, Washington, 98007

  • Neumora Investigator site

    Bellflower, California, 90706

  • Neumora Investigator Site

    Bentonville, Arkansas, 72712

  • Neumora Investigator Site

    Berlin, New Jersey, 08009

  • Neumora Investigator site

    Bloomfield Township, Michigan, 48302

  • Neumora Investigator Site

    Boston, Massachusetts, 02116

  • Neumora Investigator Site

    Boston, Massachusetts, 02131

  • Neumora Investigator Site

    Bradenton, Florida, 34205

  • Neumora Investigator Site

    Brandon, Florida, 33511

  • Neumora Investigator Site

    Brooklyn, New York, 11224

  • Neumora Investigator Site

    Buffalo, New York, 14215

  • Neumora Investigator Site

    Cedarhurst, New York, 11516

  • Neumora Investigator Site

    Cerritos, California, 90703

  • Neumora Investigator Site

    Charlotte, North Carolina, 28211

  • Neumora Investigator Site

    Chicago, Illinois, 60634

  • Neumora Investigator Site

    Colorado Springs, Colorado, 80910

  • Neumora Investigator Site

    Columbus, Ohio, 43210

  • Neumora Investigator Site

    Dallas, Texas, 75243

  • Neumora Investigator Site

    Dayton, Ohio, 45417

  • Neumora Investigator Site

    Decatur, Georgia, 30030

  • Neumora Investigator Site

    DeSoto, Texas, 75115

  • Neumora Investigator Site

    Edmond, Oklahoma, 73013

  • Neumora Investigator Site

    Encino, California, 91316

  • Neumora Investigator Site #1

    Everett, Washington, 98201

  • Neumora Investigator Site

    Flowood, Mississippi, 39232

  • Neumora Investigator Site

    Fort Worth, Texas, 76104

  • Neumora Investigator Site

    Gainesville, Florida, 32607

  • Neumora Investigator Site

    Garden Grove, California, 92845

  • Neumora Investigator Site

    Glendale, California, 91206

  • Neumora Investigator Site

    Hallandale, Florida, 33009

  • Neumora Investigator Site

    Hialeah, Florida, 33012

  • Neumora Investigator Site

    Hialeah, Florida, 33016

  • Neumora Investigator Site

    Hollywood, Florida, 33024

  • Neumora Investigator Site #1

    Houston, Texas, 77030

  • Neumora Investigator Site

    Houston, Texas, 77030

  • Neumora Investigator Site

    Houston, Texas, 77090

  • Neumora Investigator site

    Huntsville, Alabama, 35801

  • Neumora Investigator Site

    Imperial, California, 92251

  • Neumora Investigator Site

    Inwood, New York, 11096

  • Neumora Investigator Site

    Irvine, California, 92614

  • Neumora Investigator Site

    Jacksonville, Florida, 32256

  • Neumora Investigator Site

    Lafayette, California, 94549

  • Neumora Investigator Site

    Las Vegas, Nevada, 89102

  • Neumora Investigator Site

    Lauderhill, Florida, 33319

  • Neumora Investigator Site #1

    Little Rock, Arkansas, 72211

  • Neumora Investigator site

    Little Rock, Arkansas, 72211

  • Neumora Investigator Site #1

    Long Beach, California, 90807

  • Neumora Investigator site

    Long Beach, California, 90807

  • Neumora Investigator Site

    Los Angeles, California, 90015

  • Neumora Investigator Site

    Maitland, Florida, 32751

  • Neumora Investigator Site

    Mankato, Minnesota, 56001

  • Neumora Investigator Site

    Marietta, Georgia, 30060

  • Neumora Investigator Site

    Marrero, Louisiana, 70072

  • Neumora Investigator Site

    Media, Pennsylvania, 19063

  • Neumora Investigator Site

    Memphis, Tennessee, 38119

  • Neumora Investigator site

    Methuen, Massachusetts, 01844

  • Neumora Investigator Site

    Miami, Florida, 33122

  • Neumora Investigator Site

    Miami, Florida, 33126

  • Neumora Investigator Site

    Miami, Florida, 33133

  • Neumora Investigator Site

    Miami, Florida, 33137

  • Neumora Investigator Site

    Miami, Florida, 33143

  • Neumora Investigator Site

    Miami, Florida, 33165

  • Neumora Investigator Site

    Miami, Florida, 33174

  • Neumora Investigator site

    Miami, Florida, 33183

  • Neumora Investigator Site

    Miami Beach, Florida, 33140

  • Neumora Investigator site

    Miami Lakes, Florida, 33014

  • Neumora Investigator Site #1

    Miami Lakes, Florida, 33016

  • Neumora Investigator Site #2

    Miami Lakes, Florida, 33016

  • Neumora Investigator Site

    Miami Springs, Florida, 33166

  • Neumora Investigator Site

    Monroe, North Carolina, 28112

  • Neumora Investigator Site

    New Haven, Connecticut, 06520

  • Neumora Investigator Site

    New Orleans, Louisiana, 70115

  • Neumora Investigator Site

    New York, New York, 10017

  • Neumora Investigator Site

    New York, New York, 10029

  • Neumora Investigator Site

    New York, New York, 10036

  • Neumora Investigator Site

    Newport Beach, California, 92660

  • Neumora Investigator Site

    North Canton, Ohio, 44720

  • Neumora Investigator Site

    Norwalk, Connecticut, 06851

  • Neumora Investigator Site

    Oceanside, California, 92056

  • Neumora Investigator Site

    Oklahoma City, Oklahoma, 73118

  • Neumora Investigator Site #1

    Orange, California, 92868

  • Neumora Investigator Site

    Orange, California, 92868

  • Neumora Investigator Site #1

    Orlando, Florida, 32801

  • Neumora Investigator site

    Orlando, Florida, 32801

  • Neumora Investigator Site

    Orlando, Florida, 32803

  • Neumora Investigator Site

    Orlando, Florida, 32807

  • Neumora Investigator Site

    Pembroke Pines, Florida, 33024

  • Neumora Investigator Site

    Philadelphia, Pennsylvania, 19104

  • Neumora Investigator Site

    Phoenix, Arizona, 85012

  • Neumora Investigator Site #1

    Pompano Beach, Florida, 33060

  • Neumora Investigator Site

    Pompano Beach, Florida, 33060

  • Neumora Investigator site

    Princeton, New Jersey, 08540

  • Neumora Investigator Site

    Riverside, California, 92506

  • Neumora Investigator Site

    Rogers, Arkansas, 72758

  • Neumora Investigator Site

    Saint Augustine, Florida, 32086

  • Neumora Investigator Site

    Saint Charles, Missouri, 63304

  • Neumora Investigator Site

    San Diego, California, 92103

  • Neumora Investigator Site

    San Francisco, California, 94107

  • Neumora Investigator Site

    San Jose, California, 95124

  • Neumora Investigator Site

    Santa Ana, California, 92704

  • Neumora Investigator Site

    Savannah, Georgia, 31405

  • Neumora Investigator Site

    Sherman Oaks, California, 91403

  • Neumora Investigator site

    Springfield, Massachusetts, 01103

  • Neumora Investigator Site

    St Louis, Missouri, 63141

  • Neumora Investigator Site

    Staten Island, New York, 10310

  • Neumora Investigator Site

    Staten Island, New York, 10314

  • Neumora Investigator Site

    Tampa, Florida, 33607

  • Neumora Investigator Site #1

    Tampa, Florida, 33613

  • Neumora Investigator Site

    Tampa, Florida, 33613

  • Neumora Investigator Site

    Temecula, California, 92591

  • Neumora Investigator Site

    The Bronx, New York, 10461

  • Neumora Investigator Site

    Toms River, New Jersey, 08755

  • Neumora Investigator Site

    Torrance, California, 90504

  • Neumora Investigator site

    Towson, Maryland, 21204

  • Neumora Investigator Site

    Warrenville, Illinois, 60555

  • Neumora Investigator Site

    Watertown, Massachusetts, 02472

  • Neumora Investigator Site

    Wichita Falls, Texas, 76309

Other trials in United States

Bulgaria8 sites

  • Neumora Investigator Site

    Cherven Bryag, Pleven, 5980

  • Neumora Investigator Site

    Kardzhali, 6600

  • Neumora Investigator Site

    Pleven, 5800

  • Neumora Investigator Site

    Sofia, Sofia-Grad, 1408

  • Neumora Investigator Site

    Sofia, Sofia-Grad, 1463

  • Neumora Investigator Site

    Sofia, Sofia-Grad, 1680

  • Neumora Investigator Site

    Varna, 9020

  • Neumora Investigator Site

    Varosha, Targovishte, 7700

Other trials in Bulgaria

Brazil7 sites

  • Neumora Investigator Site

    Botafogo - Rio de Janeiro, Rio de Janeiro, 22270-060

  • Neumora Investigator Site

    Curitiba, Paraná, 80240280

  • Neumora Investigator Site

    Porto Alegre, Rio Grande do Sul, 90610-001

  • Neumora Investigator Site

    Santa Cecília, São Paulo, 01228-000

  • Neumora Investigator Site

    São Bernardo do Campo, São Paulo, 09726150

  • Neumora Investigator Site

    São José do Rio Preto, São Paulo, 15090-000

  • Neumora Investigator Site

    São Paulo, 01236030

Other trials in Brazil

Poland7 sites

  • Neumora Investigator Site

    Białystok, Podkarpackie Voivodeship, 15-879

  • Neumora Investigator Site

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-133

  • Neumora Investigator Site

    Gdansk, Pomeranian Voivodeship, 80-438

  • Neumora Investigator Site

    Lublin, Lublin Voivodeship, 20-109

  • Neumora Investigator Site

    Lublin, Lublin Voivodeship, 20-582

  • Neumora Investigator Site

    Suchy Las, Greater Poland Voivodeship, 62-002

  • Neumora Investigator Site

    Wroclaw, Lower Silesian Voivodeship, 50-414

Other trials in Poland

Canada5 sites

  • Neumora Investigator Site

    Hamilton, Ontario, L8S 1B7

  • Neumora Investigator Site

    Kelowna, British Columbia, V1Y 1Z9

  • Neumora Investigator Site

    Markham, Ontario, L3R 1A3

  • Neumora Investigator Site

    Mississauga, Ontario, L5L 1W8

  • Neumora Investigator Site

    Toronto, Ontario, M5S 1M2

Other trials in Canada

Chile5 sites

  • Neumora Investigator Site

    Antofagasta, 1270244

  • Neumora Investigator Site

    Santiago, Santiago Metropolitan, 7500710

  • Neumora Investigator Site

    Santiago, Santiago Metropolitan, 7560356

  • Neumora Investigator Site

    Santiago, Santiago Metropolitan, 7561282

  • Neumora Investigator Site

    Santiago, Santiago Metropolitan, 8330034

Other trials in Chile

Czechia5 sites

  • Neumora Investigator Site

    Kladno, South Bohemian, 272 01

  • Neumora Investigator Site

    Kladno, 272 01

  • Neumora Investigator Site

    Pilsen, Plzeň, 301 00

  • Neumora Investigator Site

    Prague, Prague, 186 00

  • Neumora Investigator Site

    Prague, 109 00

Other trials in Czechia

France5 sites

  • Neumora Investigator Site

    Clermont-Ferrand, Auvergne-Rhône-Alpes, 63000

  • Neumora Investigator Site

    Douai, Hauts-de-France, 59500

  • Neumora Investigator Site

    La Roche-sur-Yon, Vendée, 85000

  • Neumora Investigator Site

    Montpellier, Hérault, 34295

  • Neumora Investigator Site

    Poitiers, Vienne, 86000

Other trials in France

Germany5 sites

  • Neumora Investigator Site #1

    Berlin, 10117

  • Neumora Investigator Site

    Berlin, 10117

  • Neumora Investigator Site

    Berlin, 10629

  • Neumora Investigator Site

    Berlin, 13187

  • Neumora Investigator Site

    Hamburg, 20253

Other trials in Germany

Finland3 sites

  • Neumora Investigator Site

    Helsinki, Etelä-Suomen Lääni, 00100

  • Neumora Investigator Site

    Oulu, Oulun Lääni, 90100

  • Neumora Investigator Site

    Turku, Etelä-Suomen Lääni, 20520

Other trials in Finland

Sweden2 sites

  • Neumora Investigator Site

    Lund, Skåne County, 222 22

  • Neumora Investigator Site

    Stockholm, Stolkholm Ian, 113 29

Other trials in Sweden

About this study

Official title: Long-term Study to Assess the Safety and Effectiveness of NMRA-335140 in Participants With Major Depressive Disorder

This is a 52-week open-label extension (OLE) study that will evaluate the safety, tolerability, and effectiveness of NMRA-335140 in participants with major depressive disorder (MDD). Participants who completed a parent study investigating the efficacy and safety of NMRA-335140 as a treatment for MDD (ie, NMRA-335140-301, NMRA-335140-302, or NMRA-335140-303), and complete the 6 weeks double-blind treatment, provide informed consent, and meet eligibility criteria, may enter this extension study.

Being tested
NMRA-335140
Keywords
Major Depressive Disorder, NMRA-335140, Long-term, Safety, Efficacy, Navacaprant, NMRA335140, NMRA 335140
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.

  • NMRA-335140Drug

    Also called BTRX-335140, CYM-53093, Navacaprant

    Participants will receive NMRA-335140 at a dose of 80 mg once daily (QD), orally during a 52-week treatment period.

Study groups in NCT06029439
Study groupRoleWhat they receive
NMRA-335140 80 milligrams (mg) once daily (QD)ExperimentalParticipants will receive a NMRA-335140 tablet at a dose of 80 mg once daily (QD) during a 52-week treatment period.
Receives: Drug: NMRA-335140

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability assessments based on Treatment Emergent Adverse Events (TEAEs) and validated clinical scales

    An AE is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as treatment-emergent AE (TEAE). Clinically significant abnormalities in Clinical Laboratory Evaluations, ECGs, Vital Signs, Physical and Ophthalmological examinations, Corneal Specular Microscopy, Columbia Suicide Severity Rating Scale (C-SSRS), and Sexual Functioning Questionnaire-14 (CSFQ-14) will be reported as TEAEs.

    Measured: Up to 54 Weeks

Secondary outcomes (10)

  1. Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score over time.

    Change from baseline in MADRS total score over time will be reported. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.

    Measured: Baseline and up to Week 54

  2. Change from Baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score over time

    The SHAPS is a 14-item participant-reported instrument which measures anhedonia. It has been shown to be valid and reliable in normal and clinical samples, with adequate construct validity, satisfactory test-retest reliability, and high internal consistency. The scale will be completed by the participant and reviewed by site personnel qualified to oversee completeness. Each of the 14 items has a set of 4 responses, 2 of which endorse agreement (Definitely Agree, Agree) and 2 of which endorse disagreement (Disagree, Strongly Disagree). A total score can be derived by summing the responses; items answered with strongly agree are coded as 1 while a strongly disagree response will be coded as 4. Therefore, scores on the SHAPS can range from 14 to 56, with higher scores corresponding to higher levels of anhedonia.

    Measured: Baseline and up to Week 54

  3. Change from Baseline in the Patient Health Questionnaire-9 (PHQ-9) total score over time.

    Change from baseline in PHQ-9 total score over time will be reported. The 9-item PHQ-9 scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) diagnostic criteria for recurrent or single episode major depressive disorder (MDD) criteria and used both as a screening tool and a measure of response to treatment for depression. Each item is rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms.

    Measured: Baseline and up to Week 54

  4. Change from Baseline in PHQ-9 Anhedonia Item #1 over time.

    The PHQ-9 is a participant-rated assessment scale for the evaluation of depression symptoms over the past 2 weeks. The PHQ-9 is a reliable and valid measure of depression and depression severity. The questionnaire consists of 9 items and each item is scored from 0 to 3. Participants will be asked how often they have been bothered by symptoms over the past 2 weeks (Not at all [0], Several days [1], More than half the time [2], or Nearly every day [3]). Higher scores indicate higher levels of depression.

    Measured: Baseline and up to Week 54

  5. Change from Baseline in the Hamilton Anxiety Rating Scale (HAM-A) total score over time.

    The HAM-A is a clinician-rated instrument administered to assess severity of anxiety, its improvement during the course of treatment, and the timing of such improvement. This instrument will be completed by qualified and trained Investigator site raters based on a semi-structured interview for his/her assessment of the participant. The scale consists of 14 items. Each item is rated on a scale of 0 (feeling not present) to 4 (very severe prevalence of the feeling). The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56.

    Measured: Baseline and up to Week 54

  6. Change from Baseline in the Clinical Global Impression Scale of Severity (CGI-S)

    Change from baseline in the CGI-S total score over time will be reported. The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants. The CGI-S permits a global evaluation of the participant's condition at a given time.

    Measured: Baseline and up to Week 54

  7. Clinical Global Impression Scale of Improvement (CGI-I) score at each timepoint

    The CGI-I scale is a clinician-rated instrument that measures the improvement of the participant's symptoms of depression. It is a 7-point scale where a score of 1 indicates that the participant is "very much improved," a score of 4 indicates that the participant has experienced "no change," and a score of 7 indicates that the participant is "very much worse."

    Measured: Baseline and up to Week 54

  8. Percentage of participants whose MADRS total score decreased by greater than or equal to 50% from Baseline over time

    Measured: Up to Week 54

  9. Percentage of participants whose MADRS total score decreased to 10 or less over time

    Measured: Up to Week 54

  10. Change from baseline in the Sheehan Disability Scale (SDS) over time

    The SDS is a participant-rated instrument which was developed to assess functional impairment in 3 related domains of work/school, social, and family life. It is a brief self rated tool where the participant rates the 3 items on an anchored 10 point visual analog scale. Following the participant's self assessment, the rater should review the Work/School and Days Lost items to confirm appropriateness of the selected rating by evaluating the impact of MDD symptoms across those sectors. The SDS may be administered via telephone assessment; however, the participant must be provided with a portable document format (PDF) copy of the assessment for reference of the visual analog scale when selecting their ratings.

    Measured: Baseline and up to Week 54

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2023
  2. Study start10 Nov 2023
  3. Primary completion17 Aug 2026
  4. Study completion17 Aug 2026

Why it stopped: NMRA-335140 did not achieve the primary endpoint across three randomized controlled trials. Program discontinued due to lack of efficacy in MDD.

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
904 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06029439
Sponsor's protocol ID
NMRA-335140-501
Other IDs
KOASTAL-LT
Status last verified
Sep 2026
First submitted
1 Sep 2023
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NMRA-335140 in people with Major Depressive Disorder, run by Neumora Therapeutics, Inc. at 178 sites in 11 countries.

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 8 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 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 178 sites in United States, Bulgaria, Brazil, Poland, Canada and 6 more countries. 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 was stopped early (reason given: NMRA-335140 did not achieve the primary endpoint across three randomized controlled trials. Program discontinued due to lack of efficacy in MDD.). Results are not available in the source record.

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?

Safety and tolerability assessments based on Treatment Emergent Adverse Events (TEAEs) and validated clinical scales (time frame: Up to 54 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06029439.

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 14 Sep 2026.

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