Study on Vafidemstat for Treating Negative Symptoms and Cognitive Impairment in Adults with Schizophrenia

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for schizophrenia, a mental health condition that affects how a person thinks, feels, and behaves. The treatment being tested is a medication called vafidemstat, which is taken in the form of capsules. The study will compare the effects of vafidemstat to a placebo, which looks like the medication but does not contain any active ingredients.

The purpose of the study is to evaluate how well vafidemstat works in reducing negative symptoms and improving cognitive function in people with schizophrenia. Negative symptoms can include things like lack of motivation, reduced emotional expression, and social withdrawal, while cognitive impairment refers to difficulties with memory, attention, and problem-solving. Participants in the study will be randomly assigned to receive either vafidemstat or the placebo, and neither the participants nor the researchers will know who is receiving which treatment.

The study will last for 24 weeks, during which participants will take the capsules regularly and attend scheduled visits with the research team. These visits will help monitor the participants’ progress and any changes in their symptoms. The study aims to provide valuable information about the potential benefits of vafidemstat for individuals living with schizophrenia.

1 joining the study

Upon joining the study, you will be assigned to one of two groups: one receiving the vafidemstat medication and the other receiving a placebo. A placebo is a capsule that looks like the medication but contains no active ingredients.

The study is designed to be ‘double-blind,’ meaning neither you nor the study team will know which group you are in. This helps ensure the results are unbiased.

2 medication administration

You will take the assigned capsules orally. The dosage and frequency will be determined by the study protocol, and you will be informed of these details at the start of the trial.

The duration of the medication administration is planned for 24 weeks.

3 regular study visits

Throughout the study, you will attend regular visits to monitor your health and the effects of the medication. These visits will include assessments of your symptoms and overall well-being.

Your study partner or caregiver should accompany you to these visits to provide additional information about your cognitive and functional abilities.

4 safety and efficacy assessments

The study will evaluate the change in your symptoms using various scales and assessments, such as the PANSS (Positive and Negative Syndrome Scale) and the BACS (Brief Assessment in Cognition in Schizophrenia).

Safety will be monitored by tracking any adverse events or changes in your health status throughout the study period.

5 end of study procedures

At the end of the 24-week period, you will undergo final assessments to evaluate the overall impact of the treatment.

You will be informed about the next steps and any follow-up procedures that may be necessary.

Who Can Join the Study?

Participant must be a male or female aged between 18 and 55 years.
Participant should be healthy and medically stable based on their medical history, physical exams, and lab tests.
Participant must be able to read and write fluently and have good hearing and vision to complete the study tests.
Participant must have a negative Covid-19 test if Covid-19 precautions are still in place during the screening visit.
Participant needs a study partner or caregiver who spends at least 4 hours a week with them and can attend study visits. This person must also provide consent.
Participant must have a stable living environment for more than 6 months before the screening visit, confirmed by the study partner or caregiver.
If the participant is fertile, they must use highly effective contraception from the screening visit until 30 days after the last dose of the study medication.
Female participants who can have children must have a negative pregnancy test at screening and baseline.
Participant and their study partner or caregiver must provide signed informed consent and be able to understand and follow study requirements.
Participant must have schizophrenia as confirmed by a specific interview and meet the diagnostic criteria for more than one year.
Participant must have persistent negative symptoms of schizophrenia with minimal positive symptoms, as measured by specific scales during screening and baseline.
Participant must be stable in terms of symptoms of schizophrenia over the last 3 months, according to their psychiatrist and medical records.
Participant should be an outpatient or in day treatment with stable symptoms for at least 3 months before the screening visit, with no recent hospitalizations or changes in medication.
Participant must have a stable medication regimen for at least 3 months and agree to inform the study doctor of any medication changes during the trial.
Participant’s body mass index (BMI) should be between 18.5 and 35 kg/m² at screening. Those with a BMI between 35 and 40 kg/m² will be reviewed for safety and may need special approval.
Participant must be considered reliable and willing to follow the study rules and requirements.

Who Cannot Join the Study?

Patients who do not have a diagnosis of schizophrenia.
Patients who are not adults. This means anyone under the age of 18.
Patients who are part of a vulnerable population. This generally includes groups like pregnant women, prisoners, or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
ClinHouse Centrum Medyczne	Zabrze	Poland
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia	Bucharest	Romania
Spitalul Clinic de Psihiatrie “Dr. Gheorghe Preda” Sibiu	Sibiu	Romania
Hospital Clinico San Carlos	Madrid	Spain
Spitalul Clinic Judetean De Urgenta Cluj	Cluj Napoca	Romania
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Medical Center Hera EOOD	Sofia	Bulgaria
Centrum Medyczne Hcp Sp. z o.o.	Poznan	Poland
Diagnostics-Consultancy Center Mladost M Varna OOD	Varna	Bulgaria
Hospital Quironsalud Malaga	Malaga	Spain
Hospital Universitario General De Villalba	Madrid	Spain
Crystal Comfort s.r.o.	Vranov Nad Toplou	Slovakia
Medicover S.R.L.	Bucharest	Romania
Virgen del Rocío University Hospital	Sevilla	Spain
MBAL Dr. Ivan Seliminski – Sliven AD	Sliven	Bulgaria
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Hospital Del Mar	Barcelona	Spain
Area De Salud De Burgos Y Soria	Burgos	Spain
Multi-profile Hospital for Active Treatment Heart and Brain EAD	Pleven	Bulgaria
Complejo Asistencial De Zamora Hospital Provincial De Zamora	Zamora	Spain
State Psychiatric Hospital Sv. Ivan Rilski – Novi Iskar	Novi Iskar	Bulgaria
Psihoconcept Med S.R.L.	Selimbar	Romania
Higya–DCC OOD	Pazardzhik	Bulgaria
Nowy Szpital w Olkuszu	Olkusz	Poland
Epamed s.r.o.	Kosice	Slovakia
Medical Center Intermedica Ltd.	Sofia	Bulgaria
Outpatient Clinic for Indiv. Practice for Spec.Med. Care in Psychiatry-Dr.Madlena Dimitrova Borisova	Razgrad	Bulgaria
Multiprofile Hospital For Active Treatment Dr. Hristo Stambolski EOOD	Kazanlak	Bulgaria
State Psychiatric Hospital Lovech	Lovech	Bulgaria
Cxnqasx Bqxgq Kgxldlpwxap Pvzjyfgv Smg z odyq	Gdansk	Poland
Csvjrm Dt Scjkm Mviqmz I &bculys Lu Enan &vpcwsl Ovgpbb	Oviedo	Spain
Ctyvyh Fwp Mvcelp Hnkmmq Rnxv Elll	Ruse	Bulgaria
Masncj szzwxj	Stare Mesto	Slovakia
Iqjklqau Nzuwgtqcipcamwgs w Lnhokrcw Ssi z onts	Lublin	Poland
Hekluiyp Dm Ll Syfgt Cfjr I Ssgq Ppy	Barcelona	Spain
Cpepjuvy Hhpcpyrpuwql Umpgejdjaveef Du Vmvx	Vigo	Spain
Hvjlvxyk Vvuw dqyucguw	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Bulgaria	Not yet recruiting	16.11.2021
Poland	Not yet recruiting	16.11.2021
Romania	Not yet recruiting	16.11.2021
Slovakia	Not yet recruiting	16.11.2021
Spain	Recruiting	16.11.2021

Trial locations

Investigated drugs:

Vafidemstat

Vafidemstat is a medication being studied for its potential to help with certain symptoms of schizophrenia. Schizophrenia is a mental health condition that can cause a range of symptoms, including negative symptoms like lack of motivation or interest in activities, and cognitive impairment, which affects thinking and memory. Vafidemstat is being tested to see if it can improve these specific symptoms in people with schizophrenia. The trial aims to find out if this medication can make a positive difference in the lives of those affected by these challenging symptoms.

Investigated diseases:

Schizophrenia

Schizophrenia – Schizophrenia is a chronic mental health disorder characterized by disruptions in thought processes, perceptions, emotional responsiveness, and social interactions. It typically manifests with symptoms such as hallucinations, delusions, disorganized thinking, and significant impairments in daily functioning. The disease progresses with episodes of psychosis, where individuals may lose touch with reality, interspersed with periods of more stable functioning. Negative symptoms, such as reduced emotional expression and lack of motivation, can become more prominent over time. Cognitive impairments, including difficulties with memory, attention, and problem-solving, may also develop and persist. The course of schizophrenia varies among individuals, with some experiencing a gradual worsening of symptoms, while others may have periods of improvement.

Trial ID:

2023-507372-42-00

Protocol code:

CL09-ORY-2001

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Vafidemstat for Treating Negative Symptoms and Cognitive Impairment in Adults with Schizophrenia

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