Study of evenamide as add-on treatment for patients with treatment-resistant schizophrenia not adequately controlled by current antipsychotic medications

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What is this study about?

This study focuses on patients with treatment-resistant schizophrenia, a severe mental health condition where symptoms persist despite trying multiple medications. The study will test a new medication called evenamide in patients whose symptoms are not well controlled by their current antipsychotic medications. Treatment-resistant schizophrenia can include persistent symptoms such as disorganized thinking, hallucinations, and unusual thoughts that significantly impact daily life.

The purpose of this research is to determine if evenamide, when added to existing antipsychotic medication, can help improve schizophrenia symptoms. The study will compare two different doses of evenamide (15 mg and 30 mg taken twice daily) to a placebo. Participants will continue taking their current antipsychotic medication throughout the study.

The study will last for 52 weeks, with the main evaluation of the medication’s effectiveness occurring after 12 weeks of treatment. During this time, participants will receive either evenamide capsules or placebo capsules to take twice daily along with their regular medication. The study will monitor both how well the medication works and any side effects that may occur.

1 Initial assessment

A baseline evaluation will be performed to assess your current condition using specific rating scales

Your current symptoms and medical history will be reviewed to confirm treatment-resistant schizophrenia

You must have been on stable antipsychotic medication for at least 6 weeks before starting the study

2 Treatment assignment

You will be randomly assigned to receive either evenamide (15 mg or 30 mg) or placebo twice daily

The medication comes in capsule form and should be taken by mouth

You will continue taking your current antipsychotic medication throughout the study

3 12-week primary assessment period

You will take the study medication twice daily for 12 weeks

Regular assessments will track changes in your symptoms using the Positive and Negative Syndrome Scale (PANSS)

Your overall condition will be monitored using the Clinical Global Impression Scale (CGI-S)

Any side effects or health changes will be recorded during this period

4 Extended treatment period

The study continues for a total of 52 weeks

You will continue taking the assigned medication twice daily

Regular check-ups will continue to monitor your health and symptoms

Side effects and any changes in your condition will be documented throughout this period

5 Safety monitoring

Throughout the study, your health will be closely monitored

Any side effects will be recorded and evaluated

If you are taking clozapine, regular blood tests will be required according to local guidelines

Your medication adherence will be tracked throughout the study period

Who Can Join the Study?

  • Must be 18 years or older
  • Must have a total score of 70 or higher on the Positive and Negative Syndrome Scale (a test that measures schizophrenia symptoms)
  • Must have a score of 50 or lower on the Global Assessment of Functioning scale (a scale that measures how well you function in daily life)
  • Must be taking prescribed antipsychotic medications regularly as confirmed by caregiver
  • Must have relatively stable symptoms for at least 3 months before screening
  • Must be able to take oral medication and understand study procedures
  • Must live with a caregiver or have regular contact with a responsible person at least 3 times per week
  • Must provide written informed consent
  • Must have tried at least two different antipsychotic medications in the past without adequate improvement
  • Must be currently taking approved antipsychotic medication(s) at a stable dose for at least 6 weeks
  • Must have a Body Mass Index (BMI) between 17.5 and 35 (weight in relation to height)
  • If female and able to become pregnant, must use effective birth control during the study
  • If taking clozapine (a specific antipsychotic medication), must agree to regular blood monitoring
  • Must not be pregnant or breastfeeding if female
  • Must be rated as mildly to severely ill by the doctor using a specific rating scale

Who Cannot Join the Study?

  • Current diagnosis of substance use disorder (except nicotine or caffeine) within the past 6 months
  • History of seizures or any medical condition that could cause seizures
  • Significant heart problems or abnormal heart rhythm
  • Severe liver or kidney disease
  • Pregnant women or those planning pregnancy during the study period
  • Breastfeeding mothers
  • History of severe allergic reactions to medications
  • Participation in another clinical trial within the past 30 days
  • Unstable medical conditions that could interfere with the study
  • History of not following prescribed medical treatments
  • Significant changes in psychiatric medications within the past 4 weeks
  • Active thoughts of self-harm or suicide
  • Unable to provide informed consent
  • Any condition that, in the investigator’s opinion, makes participation unsafe
  • History of severe psychiatric symptoms that required hospitalization in the past 3 months

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Semmelweis University Budapest Hungary
Centre Hospitalier Universitaire De Nice Nice France
Hospital Del Mar Barcelona Spain
Clintrial s.r.o. Prague Czechia
A-Shine s.r.o. Plzen Czechia
Narodni Ustav Dusevniho Zdravi Klecany Czechia
Vzljde dci Rkgkp Upwhzdyede Hbqfrrdf Sevilla Spain
Hywrbxlr Crhpie Dx Bphefnvdc Barcelona Spain
Cvlyri Hhcsmvawuem Uslwucdezuhvk Dd Mhgkpbglzsg Montpellier France
Axvkcmj Obgrotukoyn Ucugeddciibfo Favlmnsl Ix Dw Nysofq Naples Italy
Khzuertm due Uuiprvrrnqdn Mncijnao Ayf Munich Germany
Uomqqaoluzmxwmcaeeypc Aqfbre Aro Aachen Germany
Uxrjnmqyjq Dmeyv Sfbba Dp Bztfdbb Brescia Italy
Cwxllrg Blhei Kpjujxwogbp Pcqavxjf Sez z ougt Gdansk Poland
Ceyxlcma Hxenhwrtgbni Urnedczopcbog Dc Vgyj Vigo Spain
Cvzwzz Fqo Malpxr Hbrfct Pxtke Dkz Ihnq Tohyod Bfxdcr Eqdo Burgas Bulgaria
Ujsjguvcucwln Sekdack Kfxjtrgze W Bjqqvrcaycv Bialystok Poland
Pvpujnzbfjqxblwjykwgu spofbq Plzen Czechia
Mlrods seztpt Brno Czechia
Ixxmmjlr db Czyolwawanif Hggzrnliqya Uvkfuxuguwmyb di Syfmd Eelyiij (ejpctsn Saint Priest En Jarez France
&ozlkrxdqftwyr Cbdrqv Mychausiopjnofroy Lcgc Plovdiv Bulgaria
Cqjjhy fnt psvtjtzsee Sjmdf Ipyn Zagreb Croatia
&olnyjherxsyk Hiojpa Ciyaqd – Vqfifu Tuxsmnjehqolzg Eahzs Vbmmnc Ttfdjfm Veliko Tirnovo Bulgaria
Safbnubzkqspsnszyfyljl Vauyxubzi Ofakwjeheuhm Nyiregyhaza Hungary
Gwfreuwgorijdklzz Vvrnivesn Prqx Ashosd Eleotfqo Oswtof Kqcorb Gyor Hungary
Azfzdpm Sndjtgceesxgml Tgmghqnlmuoz Spulf Pivjp E Colcb Milan Italy
Gxinif Uqgtbinisb Founqshrb Frankfurt Germany
Gdfaou Hvrvwdxxmyz Unveglkqvcomm Pjesi Ppjlwjvdlcd Ej Ngkkjstcaomo Paris France
Alqwurw Otialiwsdbvneoibyklefwgts Stqk Akfni Rome Italy
Cknykhev Akguthlafop Dl Zzzmxo Hxpzvdqp Przimtyqes Dd Zmwdej Zamora Spain
Mpzcbvv Cteezl Iurvfszjagg Lquv Sofia Bulgaria
&xejcbftewxaxefprag Hqlmztsp fip Aanssx Tzkitueue Dae Hfwpaw Sbmyfrcjeykobdrql Ehhrf Kmzhxwyu Kazanlak Bulgaria
Dsbnjfmrrc aux Camxfuzybvqe Cbtwtq Mwitkuc – M Vskkzkrjbvzt Opm Varna Bulgaria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
20.06.2025
Croatia Croatia
Not yet recruiting
20.06.2025
Czechia Czechia
Recruiting
20.06.2025
France France
Recruiting
20.06.2025
Germany Germany
Not yet recruiting
20.06.2025
Hungary Hungary
Not yet recruiting
20.06.2025
Italy Italy
Not yet recruiting
20.06.2025
Poland Poland
Recruiting
20.06.2025
Spain Spain
Recruiting
20.06.2025

Trial locations

Evenamide is a new medication being studied as an add-on treatment for patients with treatment-resistant schizophrenia. It works alongside existing antipsychotic medications when the current treatment alone is not providing adequate control of schizophrenia symptoms. This medication is being tested to see if it can help improve the symptoms of schizophrenia when other treatments haven’t worked well enough.

Antipsychotic medications (current patient medications) are medicines that patients in the trial will continue taking at their usual stable dose. These are the existing medications that patients were already using to manage their schizophrenia symptoms before joining the study.

Treatment-resistant schizophrenia – A severe form of schizophrenia where symptoms persist despite adequate treatment with standard antipsychotic medications. This condition is characterized by ongoing hallucinations, delusions, and disorganized thinking that continue even when patients take their prescribed medications as directed. Patients with this form of schizophrenia experience persistent positive symptoms (such as hearing voices or having false beliefs) and negative symptoms (such as reduced emotional expression or lack of motivation). The condition typically develops after a person has shown insufficient response to at least two different antipsychotic medications taken at appropriate doses for an adequate duration.

Trial ID:
2024-519836-18-00
Protocol code:
NW-3509/023/III/2024
Trial Phase:
Therapeutic confirmatory (Phase III)

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