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
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Universitaetsklinikum Aachen AöR Aachen Germany
Hospital Del Mar Barcelona Spain
Complejo Asistencial De Zamora Hospital Provincial De Zamora Zamora Spain
Narodni Ustav Dusevniho Zdravi Klecany Czechia
Centrum Medyczne Luxmed Sp. z o.o. Lublin Poland
Clintrial s.r.o. Prague Czechia
A-Shine s.r.o. Plzen Czechia
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Virgen del Rocío University Hospital Sevilla Spain
Hospital Clinic De Barcelona Barcelona Spain
Semmelweis University Budapest Hungary
Centre Hospitalier Universitaire De Montpellier Montpellier France
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo Milan Italy
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Universita Degli Studi Di Brescia Brescia Italy
Medical Center Intermedica Ltd. Sofia Bulgaria
Clinic for psychiatry Sveti Ivan Zagreb Croatia
“Mental Health Center – Veliko Tarnovo” EOOD, Veliko Tarnovo Veliko Tirnovo Bulgaria
“Multiprofile Hospital for Active Treatment Dr. Hristo Stambolski” EOOD, Kazanlak Kazanlak Bulgaria
Diagnostic and Consultative Center Mladost – M Varna” OOD Varna Bulgaria
Cvunyle Bazcv Knuqczddzww Pmhtkzrf Ssn z ozyy Gdansk Poland
Ctmjkuax Hinjqpmbjhjx Uczxvwvlvmwlt Dy Vabn Vigo Spain
&ezfricnhogych Csdhed Meccwqledxbwgomkp Lyvh Plovdiv Bulgaria
Mafsvz sfwrcl Brno Czechia
Gbujgw Hnpagpixrmm Ufkgmmeryiqvm Pamfe Pguwkbliakk Ez Ndmihgxhrrxs Paris France
Kcozhztl bmaxmhvi cioupp Rymrud (tshkpzoc Haooxduv Cipgdp Revomcn Rijeka Croatia
Gkjvaaucprpzfoagh Vleokodyr Puis Abgdez Ewaopvsw Okssta Kgjxvz Gyor Hungary
Kzagxzmh dkm Uegtnrdzukne Mhzyutid Avu Munich Germany
Ugswotrzeugvac Czdmnoq Knwkpxojs Gdansk Poland
Chqrhy Fhd Moojzr Helwqs Pkjro Dhq Ivbw Tmwfjk Bmevtb Ebfz Burgas Bulgaria
Pzzvxnuuanevhwoqhrlef swqtkv Plzen Czechia
Izizkmcy dg Cfqzavlmfdvo Hcigbdrrtjp Uwntsiihalibx df Souhn Epqsyko (tbhyhgp Saint Priest En Jarez France
Geodxs Uwlngnfpju Flmissivx Frankfurt Germany

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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