Evidence map›Paper›PMID 37349110›Full record

Trial reportThe international journal of neuropsychopharmacology2023

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.

Ravi Anand, Alessio Turolla, Giovanni Chinellato, Arjun Roy, Richard D Hartman

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in The international journal of neuropsychopharmacology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07184619 (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), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07184619 phase3recruitingnot on this mapstarted 2026, after this paper: background citation

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)

TypeinterventionalSponsorNewron Pharmaceuticals SPARan2026 to 2026Enrolled400ConditionsTreatment-resistant SchizophreniaArmsEvenamide 15 mg bid, Placebo
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Research progress in estrogen as an adjunctive therapy for schizophrenia.Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2024
    Pooled it
  2. Trial
  3. Review
  4. Review
  5. Review
  6. Review
  7. Article
  8. Evenamide reverses schizophrenia-related dysfunction in a neurodevelopmental animal model.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2025
    Article
  9. Review
  10. Review
  11. Article
  12. Review
  13. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Ravi AnandAPC, St. Moritz, Switzerland.
Alessio TurollaNewron Pharmaceuticals SpA, Bresso, Italy.
Giovanni ChinellatoNewron Pharmaceuticals SpA, Bresso, Italy.ORCID 0009-0001-7091-8672
Arjun RoyCliniRx Research Pvt Ltd, New Delhi, India.
Richard D HartmanNeurWrite LLC, Morristown, NJ, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Results from a pilot, 6-week, randomized, open-label, rater-blinded study, with 46-week extension, indicate very good tolerability with exceptional, clinically important, increasing efficacy of evenamide (7.5, 15, and 30 mg bid), a glutamate modulator, as add-on treatment to antipsychotics in 161 treatment-resistant, schizophrenia patients. Ninety-five percent of patients completed 6 weeks (1 discontinued for adverse event), and 89% continued in the extension. Results from the first 100 patients enrolled showed very low attrition over 1 year (77 completers); data pooled from all dose groups showed the Positive and Negative Syndrome Scale total score improved significantly (P < .001; paired t test; last observation carried forward [LOCF]) from baseline at 6 weeks (-9.4), 6 months (-12.7), and 1 year (-14.7); similarly, the proportion of responders (≥20% improvement) increased over time from 6 weeks (16.5%) to 6 months (39%) to 1 year (47.4%). Noteworthy improvement was also observed at each timepoint on the Clinical Global Impression - Severity scale and Clinical Global Impression of Change, indicating progressively increasing efficacy of evenamide up to 1 year.

Indexed as

Antipsychotic AgentsSchizophreniaGlutamic AcidHumansSchizophrenia, Treatment-ResistantAntipsychotic AgentsGlutamic Acidadd-onevenamideglutamatelong-termTreatment-resistant schizophrenia

Identifiers

PMID37349110
PMCPMC10464926

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.