#1 Clinical Trials Search in Europe

A study to evaluate the effectiveness and safety of NBI-1117570 in adults with schizophrenia who require hospital treatment.

2 1

What is this study about?

This study aims to evaluate the effectiveness and safety of the experimental drug NBI-1117570 in adults diagnosed with Schizophrenia, a mental health disorder that can affect how a person thinks, feels, and behaves. The research focuses on individuals who require inpatient hospitalization, which means staying in a hospital facility to receive constant care and supervision. Participants will be assigned to receive either NBI-1117570, which is administered in the form of an oral capsule, or a placebo.

The study is a randomized and double-blind trial, meaning that participants are assigned to groups by chance and neither the individuals nor the medical staff know which specific treatment is being given during the study period. This design helps ensure that the results are based on the actual effects of the medication. Researchers will observe how the medication affects the behavioral and psychological symptoms of the condition over time.

Who Can Join the Study?

  • You must be between 18 and 55 years old.
  • Your main diagnosis must be schizophrenia, which is a long-term mental health condition, and this diagnosis must have been made at least 1 year before joining this study.
  • You must be experiencing an acute exacerbation, which means a sudden worsening or a sudden increase in the severity of your symptoms, or a relapse, which is a return of symptoms after a period of improvement.
  • These worsening symptoms must have started less than 2 months before your screening.
  • You must currently require inpatient hospitalization, meaning you need to stay in a hospital to receive care.
  • You must have had a positive response, meaning the treatment worked well for you, to at least one antipsychotic therapy (medicine used to manage symptoms of psychosis), excluding a specific medicine called clozapine, when treating a previous episode of worsening symptoms.

Who Cannot Join the Study?

  • People who are thought to be at immediate risk of suicide (attempting to end their own life) or harming themselves or other people.
  • Anyone with a history of epilepsy (a condition that causes repeated seizures), seizures (sudden electrical disturbances in the brain), or convulsions (uncontrollable shaking of the body).
  • People with orthostatic hypotension (a sudden drop in blood pressure when standing up).
  • People with a history of pulmonary hypertension (high blood pressure in the arteries of the lungs).
  • People with obstructive coronary artery disease (a condition where blood flow to the heart is partially blocked by buildup in the arteries).
  • People with hypertrophic cardiomyopathy (a condition where the heart muscle becomes abnormally thick).
  • People who have had a myocardial infarction (commonly known as a heart attack).
  • People who have undergone coronary artery revascularization (a procedure to improve blood flow to the heart, such as placing a stent or bypass surgery).
  • People with heart failure (a condition where the heart cannot pump blood effectively enough to meet the body’s needs).
  • People with left ventricular hypertrophy (a thickening of the heart’s main pumping chamber).
  • People with moderate or severe cardiac valvopathy (problems or diseases affecting the valves that control blood flow in the heart).
  • People with any other cardiovascular conditions (heart or blood vessel problems) that would make it unsafe to participate.
  • People who are currently taking prohibited medications (specific medicines that are not allowed during this study).
  • People who are pregnant or lactating (breastfeeding).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Centrum Medyczne Hcp Sp. z o.o. Poznan Poland
State Psychiatric Hospital Pazardzhik Pazardzhik Bulgaria
Multiprofile Hospital For Active Treatment – Targovishte AD Targovishte Bulgaria
Spitalul Clinic Judetean Mures Targu Mures Romania
Institutul De Psihiatrie Socola Lasi Iasi Romania
Multiprofile Hospital For Active Treatment Dr. Hristo Stambolski EOOD Kazanlak Bulgaria
Multi-profile Hospital for Active Treatment Heart and Brain EAD Pleven Bulgaria
Usnwgpnamuspxg Cmutpjn Kxmngqwmr Gdansk Poland

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
28.02.2026
Poland Poland
Not yet recruiting
28.02.2026
Romania Romania
Recruiting
28.02.2026

Trial locations

Investigated drugs:

NBI-1117570 is an experimental medication taken by mouth in capsule form that is being studied to see if it can help improve the behavior and mental symptoms in adults living with schizophrenia.

Schizophrenia – This is a long-term mental health disorder that affects how a person thinks, feels, and behaves. It often involves a disconnection from reality, which can manifest as seeing or hearing things that are not there. People may also experience disorganized thinking or unusual belief systems. The symptoms can fluctuate in intensity over time. As the condition progresses, it can impact a person’s ability to manage daily activities and social interactions.

Trial ID:
2025-521868-35-00
Protocol code:
NBI-1117570-SCZ2035
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • A study testing direclidine compared to placebo in adults with schizophrenia who need hospital care

    Recruiting

    3 1
    Bulgaria Hungary Romania

  • A Study Testing Brexpiprazole Given Once Weekly to Treat Sudden Worsening of Symptoms in Patients with Schizophrenia

    Recruiting

    3 1 1
    Investigated drugs:
    Romania