Treatment-resistant SchizophreniaPhase 3ENIGMA-TRS 2NCT07184619
Evenamide, a Glutamate Release Modulator, as Add-On to Standard of Care in Subjects With Documented Treatment-Resistant Schizophrenia
A Phase 3 study testing Evenamide 15 mg bid in people with Treatment-resistant Schizophrenia, run by Newron Pharmaceuticals SPA at 19 sites in 4 countries.
Trial summary
This is a prospective, 12-week, randomized, double-blind, placebo-controlled study, designed to evaluate the efficacy, safety, and tolerability of a dose of evenamide of 15 mg bid, compared to placebo, as add-on treatment in patients with documented treatment-resistant schizophrenia (TRS) who have prospectively… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment-resistant Schizophrenia
- What is being tested?
- Evenamide 15 mg bid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 19 sitesin 4 countries
- Study dates
- 23 Jan 2026to 31 Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age - 18 years, or older.
- If female, the subject has a negative pregnancy test at the screening visit and at baseline, is not lactating, and agrees to use adequate contraception, unless not of childbearing potential.
- Meets current DSM-5-TR criteria for schizophrenia.
- Has shown treatment-resistance to antipsychotics as per TRRIP working group definition (Howes et al., 2017).
- Currently receiving "standard of care" therapy of a minimal recommended therapeutic dose of one or more antipsychotic(s).
- Has a Clinical Global Impression - Severity of disease (CGI-S) rating of "mildly ill" to "among the most extremly ill" at baseline.
Show all 11Show fewer
- Has a BPRS total score ≥ 45 at screening and baseline.
- Has a PANSS total score ≥ 70 at baseline.
- Has a Global Assessment of Functioning (GAF) scale total score ≤ 50.
- Adherence to prescribed antipsychotic treatment.
- Patient has provided written informed consent prior to participating in the study.
Who cannot join
- Current DSM-5-TR diagnosis of schizophreniform disorder, schizoaffective disorder, or other primary psychiatric diagnosis, such as bipolar disorder or major depressive disorder
- History (within three months of study entry) or current diagnosis of "Substance Use Disorder" as defined by the DSM-5-TR criteria.
- Severity of current episode of psychosis requires that the patient be hospitalized to stabilize the severity of his/her psychotic symptoms. However, these patients may qualify for the study provided their antipsychotic dose has been stable for 6 weeks prior to screening.
- History or current diagnosis of other psychiatric or behavioral disorders.
- Known suicidal risk, or a suicide attempt within the past 2 years.
- History of neuroleptic malignant syndrome or priapism.
- Disease/medical condition of any type that may impact the patient's safety or interfere with any of the study evaluations.
- History or current diagnosis of epilepsy or seizure disorder, or occurrence of a seizure within the past year, or repeated drug-induced seizures.
Trial locations and contacts
19 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
19 sites in 4 countries
India9 sites, 9 recruiting
- Not yet recruiting
All India Institute of Medical Sciences
Bībīnagar, Telangana, 508126
Sai Krishna Tikka, +918298041330, saikiatry@gmail.com
- Recruiting
Gauhati Medical College and Hospital
Guwahati, Assam, 781032
Site Contact, +919101026990, pulakeshd@infoclinconsultancy.com
- Not yet recruiting
Seth Sukhlal Karnani Memorial Hospital
Kolkata, West Bengal, 700025
Site Contact, +919836074700, sujitsarkhel@gmail.com
- Recruiting
Udyan Health Care
Lucknow, Uttar Pradesh, 226012
Site Contact, +919651970700, adarshbraincare@gmail.com
- Recruiting
Ahana Hospitals LLP
Madurai, Tamil Nadu, 625020
Site Contact, +919443772233, vikhram@ahanahospitals.in
- Recruiting
Masina Hospital Trust
Mumbai, Maharashtra, 400027
Site Contact, +919820164327, akmital@gmail.com
- Not yet recruiting
All India Institute Of Medical Sciences
Nagpur, Maharashtra, 441108
Sonakshi Jyrwa, +919953954055, sjdanielle@gmail.com
- Recruiting
New Manak Healthcare Hospital
Navi Mumbai, Maharashtra, 400706
Site Contact, +919321488168, manakhealthcare@gmail.com
- Recruiting
Help Hospital
Vijayawada, Andhra Pradesh, 520002
Site Contact, +919848229798, rrvemireddy@yahoo.com
United States5 sites
- Suspended
Grady Behavioral Health Center, -Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine
Atlanta, Georgia, 30322
- Suspended
Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224
- Suspended
UCLA DGSOM, UCLA Health, UCLA Semel Institute
Los Angeles, California, 90095
- Suspended
University of Miami, Miller School of Medicine; Jackson Behavioral Health Hospital
Miami, Florida, 33136
- Suspended
Manhattan Psychiatric Center, The Nathan Kline Institute for Psychiatric Research
New York, New York, 10035
Malaysia4 sites, 4 recruiting
- Recruiting
Hospital Tuanku Fauziah
Kangar, 01000
Site Contact, +60182548066, sitiertina@clinicalresearch.my
- Recruiting
Kuala Lumpur Hospital
Kuala Lumpur, Kuala Lumpur, 50586
Mohd Hafiz Bin Norzan, +60123927233, drhafizmdresearch@gmail.com
- Recruiting
Sentosa Hospital
Kuching, 93250
Site Contact, +60198445097, azwani75@gmail.com
- Recruiting
Sultan Abdul Halim Hospital
Sungai Petani, 08000
Site Contact, +60125055587, tewmeimei@moh.gov.my
Argentina1 site
- Active, not recruiting
Fundación para el Estudio y Tratamiento de las Enfermedades Mentales
Buenos Aires, Buenos Aires F.D., 1133
About this study
Official title: A Phase III, 12-week, Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Determine the Efficacy, Safety, and Tolerability of a Dose of 15 mg Bid of Evenamide as add-on in Patients With Documented Treatment-resistant Schizophrenia, Which is Not Adequately Controlled by a Stable Therapeutic Dose of the Patient's Current Antipsychotic Medication(s)
This is a prospective, 12-week, randomized, double-blind, placebo-controlled study, designed to evaluate the efficacy, safety, and tolerability of a dose of evenamide of 15 mg bid, compared to placebo, as add-on treatment in patients with documented treatment-resistant schizophrenia (TRS) who have prospectively demonstrated inadequate response to their current stable therapeutic dose of an antipsychotic(s). Approximately 400 patients will be randomized equally (1:1) to each of the two treatment groups in this study.
- Conditions
- Treatment-resistant Schizophrenia
- Being tested
- Evenamide 15 mg bid, Placebo
- Keywords
- evenamide, treatment-resistant schizophrenia, antipsychotic, schizophrenia, TRS, add-on treatment
- Medical subject headings
- Schizophrenia, Treatment-Resistant, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evenamide 15 mg bidDrug
Evenamide capsules 15 mg bid for a total of 12 weeks of add-on treatment
PlaceboDrug
Matching placebo capsules bid for a total of 12 weeks of add-on treatment
| Study group | Role | What they receive |
|---|---|---|
| Evenamide 15 mg bid | Experimental | Evenamide capsules 15 mg bid for a total of 12 weeks of add-on treatment Receives: Drug: Evenamide 15 mg bid |
| Placebo | Placebo comparator | Matching placebo capsules bid for a total of 12 weeks of add-on treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to endpoint (Week 12) on the total score of the Positive and Negative Syndrome Scale (PANSS).
Efficacy measured by the mean change from baseline to endpoint of Positive and Negative Syndrome Scale [PANSS] total score: a 30-item scale that was designed to assess various symptoms of schizophrenia each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology).
Measured: From Baseline to Week 12
Incidence of treatment-emergent adverse events (TEAEs), AEs leading to discontinuation (ADOs), and serious AEs (SAEs).
Safety and tolerability of a dose of evenamide of 15 mg bid, compared to placebo. The assessment of safety and tolerability will be based primarily on the incidence of treatment-emergent adverse events (TEAEs), AEs leading to discontinuation (ADOs), and serious AEs (SAEs).
Measured: From Baseline to 30-day Safety Follow up (12 Weeks of treament + 30-day safety follow up)
Secondary outcomes (5)
Change from baseline to endpoint (Week 12) on the Clinical Global Impression - Severity of illness (CGI-S) score.
Efficacy measured by the mean change from baseline to endpoint on the Clinical Global Impression Severity of Illness (CGI-S) scale: a 7-point scale ranging from 1 (no symptoms) to 7 (very severe) to assess the severity of a subject's condition.
Measured: From Baseline to Week 12
Proportion of patients rated as 'improved' on the CGI-C at endpoint (Week 12).
Efficacy measured by Clinical Global Impression of Change [CGI-C]: a 7-point scale, ranging from 1 (very much improved) to 7 (very much worse), with a score of 4 indicating "no change". Patients with ratings of 1,2 or 3 are considered as 'improved'.
Measured: Week 12
Change from baseline to endpoint (Week 12) on the Positive Symptoms sub-scale score of the PANSS.
Efficacy measured by the mean change from baseline to endpoint on the Positive subscale score of the PANSS: a 7-item subscale designed to assess positive symptoms of schizophrenia each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology).
Measured: From Baseline to Week 12
Change from baseline to endpoint (Week 12) on the Personal and Social Performance (PSP) scale.
Efficacy measured by the mean change from baseline to endpoint on the PSP scale: a 100-point single-item rating scale subdivided into 10 equal intervals that designed to assess the routine social functioning of patients with psychiatric disorders.
Measured: From Baseline to Week 12
Change from baseline to endpoint (Week 12) on the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form scale (Q-LES-Q-SF).
Efficacy measured by the mean change from baseline to endpoint on the total score of the Quality of Life Enjoyment and Satisfaction Questionnaire: a 16-item scale, each rated from 1 (very poor) to 5 (very good).
Measured: From Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start23 Jan 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Treatment-resistant SchizophreniaStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newron Pharmaceuticals SPA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ravi Anand, MD, Study director, Newron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184619
- Sponsor's protocol ID
- NW-3509/022/III/2024
- Acronym
- ENIGMA-TRS 2
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Anand R, Turolla A, Chinellato G, Sansi F, Roy A, Hartman R. Efficacy and safety of evenamide, a glutamate modulator, added to a second-generation antipsychotic in inadequately/poorly responding patients with chronic schizophrenia: Results from a randomized, double-blind, placebo-controlled, phase 3, international clinical trial. Neuropharmacology. 2025 Mar 15;266:110275. doi: 10.1016/j.neuropharm.2024.110275. Epub 2024 Dec 19.
PubMed 39708914Anand R, Turolla A, Chinellato G, Roy A, Hartman RD. Therapeutic Effect of Evenamide, a Glutamate Inhibitor, in Patients With Treatment-Resistant Schizophrenia (TRS): Final, 1-Year Results From a Phase 2, Open-Label, Rater-Blinded, Randomized, International Clinical Trial. Int J Neuropsychopharmacol. 2024 Dec 28;28(1):pyae061. doi: 10.1093/ijnp/pyae061.
PubMed 39661380Anand R, Turolla A, Chinellato G, Roy A, Hartman RD. Phase 2 Results Indicate Evenamide, A Selective Modulator of Glutamate Release, Is Associated With Clinically Important Long-Term Efficacy When Added to an Antipsychotic in Patients With Treatment-Resistant Schizophrenia. Int J Neuropsychopharmacol. 2023 Aug 29;26(8):523-528. doi: 10.1093/ijnp/pyad035.
PubMed 37349110
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, 12-week, Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Determine the Efficacy, Safety, and Tolerability of a Dose of 15 mg Bid of Evenamide as add-on in Patients With Documented Treatment-resistant Schizophrenia, Which is Not Adequately Controlled by a Stable Therapeutic Dose of the Patient's Current Antipsychotic Medication(s)
- ClinicalTrials.gov ID
- NCT07184619
- Acronym / sponsor ID
- ENIGMA-TRS 2 / NW-3509/022/III/2024
- Conditions
- Treatment-resistant Schizophrenia
- Keywords
- evenamide, treatment-resistant schizophrenia, antipsychotic, schizophrenia, TRS, add-on treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Newron Pharmaceuticals SPAIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 22 Sep 2025 (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.
This is a prospective, 12-week, randomized, double-blind, placebo-controlled study, designed to evaluate the efficacy, safety, and tolerability of a dose of evenamide of 15 mg bid, compared to placebo, as add-on treatment in patients with documented treatment-resistant schizophrenia (TRS) who have prospectively demonstrated inadequate response to their current stable therapeutic dose of an antipsychotic(s). Approximately 400 patients will be randomized equally (1:1) to each of the two treatment groups in this study.
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 |
|---|---|---|
| Evenamide 15 mg bid | Experimental | Drug: Evenamide 15 mg bidEvenamide capsules 15 mg bid for a total of 12 weeks of add-on treatment |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo capsules bid for a total of 12 weeks of add-on treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age - 18 years, or older.
- If female, the subject has a negative pregnancy test at the screening visit and at baseline, is not lactating, and agrees to use adequate contraception, unless not of childbearing potential.
- Meets current DSM-5-TR criteria for schizophrenia.
- Has shown treatment-resistance to antipsychotics as per TRRIP working group definition (Howes et al., 2017).
- Currently receiving "standard of care" therapy of a minimal recommended therapeutic dose of one or more antipsychotic(s).
Key exclusion criteria (8 listed)
- Current DSM-5-TR diagnosis of schizophreniform disorder, schizoaffective disorder, or other primary psychiatric diagnosis, such as bipolar disorder or major depressive disorder
- History (within three months of study entry) or current diagnosis of "Substance Use Disorder" as defined by the DSM-5-TR criteria.
- Severity of current episode of psychosis requires that the patient be hospitalized to stabilize the severity of his/her psychotic symptoms. However, these patients may qualify for the study provided their antipsychotic dose has been stable for 6 weeks prior to screening.
- History or current diagnosis of other psychiatric or behavioral disorders.
- Known suicidal risk, or a suicide attempt within the past 2 years.
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 |
|---|---|---|
| Evenamide 15 mg bidEvenamide capsules 15 mg bid for a total of 12 weeks of add-on treatment | Drug | Evenamide 15 mg bid |
| PlaceboMatching placebo capsules bid for a total of 12 weeks of add-on treatment | Drug | Placebo |
Primary outcome
Change from baseline to endpoint (Week 12) on the total score of the Positive and Negative Syndrome Scale (PANSS).
Time frame: From Baseline to Week 12
Efficacy measured by the mean change from baseline to endpoint of Positive and Negative Syndrome Scale [PANSS] total score: a 30-item scale that was designed to assess various symptoms of schizophrenia each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology).
Incidence of treatment-emergent adverse events (TEAEs), AEs leading to discontinuation (ADOs), and serious AEs (SAEs).
Time frame: From Baseline to 30-day Safety Follow up (12 Weeks of treament + 30-day safety follow up)
Safety and tolerability of a dose of evenamide of 15 mg bid, compared to placebo. The assessment of safety and tolerability will be based primarily on the incidence of treatment-emergent adverse events (TEAEs), AEs leading to discontinuation (ADOs), and serious AEs (SAEs).
5 secondary outcomes
Change from baseline to endpoint (Week 12) on the Clinical Global Impression - Severity of illness (CGI-S) score.
Time frame: From Baseline to Week 12
Proportion of patients rated as 'improved' on the CGI-C at endpoint (Week 12).
Time frame: Week 12
Change from baseline to endpoint (Week 12) on the Positive Symptoms sub-scale score of the PANSS.
Time frame: From Baseline to Week 12
Change from baseline to endpoint (Week 12) on the Personal and Social Performance (PSP) scale.
Time frame: From Baseline to Week 12
Change from baseline to endpoint (Week 12) on the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form scale (Q-LES-Q-SF).
Time frame: From Baseline to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 39708914Anand R, Turolla A, Chinellato G, Sansi F, Roy A, Hartman R. Efficacy and safety of evenamide, a glutamate modulator, added to a second-generation antipsychotic in inadequately/poorly responding patients with chronic schizophrenia: Results from a randomized, double-blind, placebo-controlled, phase 3, international clinical trial. Neuropharmacology. 2025 Mar 15;266:110275. doi: 10.1016/j.neuropharm.2024.110275. Epub 2024 Dec 19.
- Background: PubMed 39661380Anand R, Turolla A, Chinellato G, Roy A, Hartman RD. Therapeutic Effect of Evenamide, a Glutamate Inhibitor, in Patients With Treatment-Resistant Schizophrenia (TRS): Final, 1-Year Results From a Phase 2, Open-Label, Rater-Blinded, Randomized, International Clinical Trial. Int J Neuropsychopharmacol. 2024 Dec 28;28(1):pyae061. doi: 10.1093/ijnp/pyae061.
- Background: PubMed 37349110Anand R, Turolla A, Chinellato G, Roy A, Hartman RD. Phase 2 Results Indicate Evenamide, A Selective Modulator of Glutamate Release, Is Associated With Clinically Important Long-Term Efficacy When Added to an Antipsychotic in Patients With Treatment-Resistant Schizophrenia. Int J Neuropsychopharmacol. 2023 Aug 29;26(8):523-528. doi: 10.1093/ijnp/pyad035.
- Individual participant dataSharing planned: Undecided
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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.
Ravi Anand, MD study director
Newron Pharmaceuticals
19 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Evenamide 15 mg bid in people with Treatment-resistant Schizophrenia, run by Newron Pharmaceuticals SPA at 19 sites in 4 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 11 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: looking for participants now, as of the sponsor's last update on 10 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 19 sites in India, United States, Malaysia, Argentina. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Newron Pharmaceuticals (+39 02 610 3461, info@newron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to endpoint (Week 12) on the total score of the Positive and Negative Syndrome Scale (PANSS). (time frame: From Baseline to Week 12). 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?
On the ClinicalTrials.gov record for NCT07184619, which also lists 3 linked publications.
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 10 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.