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

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What is this study about?

This study is looking at schizophrenia, which is a mental health condition that affects how a person thinks, feels, and behaves. People with schizophrenia may experience symptoms such as hearing voices, having unusual beliefs, feeling confused, or having difficulty organizing their thoughts. The treatment being tested is called NBI-1117568, also known by its scientific name direclidine, which comes in capsule form and is taken by mouth. Some people in the study will receive the actual medication while others will receive a placebo.

The purpose of this study is to see if NBI-1117568 works better than placebo at improving the behavioral and psychological symptoms of schizophrenia in adults. The study will look at whether the medication can help reduce symptoms and improve the overall condition of people who are experiencing a sudden worsening of their schizophrenia symptoms that requires them to stay in the hospital. The study will also check how safe the medication is and whether people can tolerate it well.

People taking part in this study will be adults with schizophrenia who are currently in the hospital because their symptoms have gotten worse recently. The study will last for 5 weeks, during which time participants will take either NBI-1117568 or placebo capsules. Throughout the study, doctors will measure changes in symptoms using rating scales to see how well the treatment is working compared to placebo.

1 Initial hospitalization and baseline assessment

Upon joining the study, you will be hospitalized as an inpatient. This hospitalization is necessary because your symptoms have suddenly worsened or returned within the last two months.

During this initial phase, your condition will be assessed using standardized rating scales. The PANSS (Positive and Negative Syndrome Scale) will be used to measure the severity of your symptoms. This scale evaluates various aspects of your condition including positive symptoms (such as hallucinations or delusions), negative symptoms (such as reduced emotional expression), and general symptoms.

Your overall illness severity will also be evaluated using the CGI-S (Clinical Global Impression-Severity) scale, which provides a general assessment of how severe your condition is at this starting point.

These initial measurements will serve as the baseline to compare changes throughout the study.

2 Treatment period with study medication

You will be randomly assigned to receive either NBI-1117568 (the active study medication containing direclidine) or a placebo (an inactive capsule that looks identical to the active medication but contains no active substance).

The study is double-blind, which means neither you nor your medical team will know which treatment you are receiving during the study period.

You will take the assigned medication orally in the form of hard capsules.

The treatment period will last for 5 weeks.

Throughout this period, you will remain hospitalized so that your response to the treatment and any side effects can be closely monitored.

3 Regular monitoring and assessments

During the 5-week treatment period, your behavioral and psychological symptoms will be regularly evaluated.

Your medical team will monitor your safety and how well you tolerate the study medication.

Regular assessments will be conducted to track any changes in your symptoms and overall condition.

4 Final assessment at week 5

At the end of the 5-week treatment period, a final comprehensive assessment will be performed.

The same rating scales used at the beginning (PANSS and CGI-S) will be used again to measure any changes in your symptoms compared to the baseline.

The change in your PANSS total score from the beginning to week 5 will be the primary measure of whether the treatment was effective.

The change in your CGI-S score from the beginning to week 5 will provide additional information about your overall improvement.

Who Can Join the Study?

You must be 18 years old or older and 65 years old or younger
You must have a main diagnosis of schizophrenia, which is a mental health condition that affects how a person thinks, feels, and behaves
You must be experiencing a sudden worsening or return of symptoms that started less than 2 months before the screening visit
Your current symptoms must be serious enough that you need to stay in a hospital for treatment

Who Cannot Join the Study?

The study does not include children or teenagers, only adults can participate
Patients who do not have a confirmed diagnosis of schizophrenia (a mental health condition that affects how a person thinks, feels, and behaves) cannot participate
People who are allergic or have had bad reactions to the study medication NBI-1117568 or similar medications cannot join
Patients who are currently participating in another clinical trial or have recently finished one may not be eligible
Women who are pregnant or breastfeeding cannot participate in this study
People with serious medical conditions affecting the heart, liver, kidneys, or other major organs may not be able to join
Patients with a history of drug or alcohol abuse within a recent period may be excluded
People who have attempted suicide recently or have active thoughts of harming themselves cannot participate
Patients taking certain medications that might interact with the study drug may not be eligible
People who cannot follow the study requirements or attend regular visits may be excluded

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia	Bucharest	Romania

Other Sites

Site Name	City	Country
Clinexpert Kft.	Budapest	Hungary
Spitalul Clinic De Psihiatrie Si Neurologie Brasov	Brasov	Romania
State Psychiatric Hospital Tserova Koria	Veliko Tirnovo	Bulgaria
Semmelweis University	Budapest	Hungary
MBAL Dr. Ivan Seliminski – Sliven AD	Sliven	Bulgaria
Gyongyosi Bugat Pal Korhaz	Gyongyos	Hungary
Centru De Evaluare Si Tratament A Toxicodependentelor Pentru Tineri Sf. Stelian	Bucharest	Romania
Multi-profile Hospital for Active Treatment Heart and Brain EAD	Pleven	Bulgaria
Institutul De Psihiatrie Socola Lasi	Iasi	Romania
Bpvqsjnkncu Vortuwmke Ohuhrpvqhhlr	Kecskemet	Hungary
Glxlhheyqdlhrnnag Vufgzfttg Pnmw Afdemu Eabvjghy Otrkgk Khmpgq	Gyor	Hungary
Cehfbh Fyu Myakgh Hbbutz Vwmucm Evty	Vratsa	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Recruiting	15.10.2025
Hungary	Recruiting	15.10.2025
Romania	Recruiting	15.10.2025

Trial locations

NBI-1117568 is an investigational medication being studied for the treatment of schizophrenia. This medicine is being tested to see if it can help improve behavioral and psychological symptoms in adults with schizophrenia who need to stay in the hospital for treatment. The study will compare how well this medication works against a placebo to determine its effectiveness and safety.

Placebo is an inactive substance that looks like the real medication but contains no active medicine. It is used in this study to compare against the investigational medication to help researchers understand if the actual medication is working better than no treatment at all.

Schizophrenia – Schizophrenia is a chronic mental disorder that affects how a person thinks, feels, and behaves. People with this condition may experience distorted perceptions of reality, including hallucinations where they see or hear things that are not present, and delusions which are false beliefs. The disorder also causes disorganized thinking and speech, making it difficult for affected individuals to communicate clearly or follow logical thought patterns. Behavioral symptoms include reduced emotional expression, decreased motivation, and withdrawal from social activities. The condition typically emerges in late adolescence or early adulthood and tends to persist throughout life with varying levels of severity. Symptoms are generally categorized as positive symptoms such as hallucinations and delusions, negative symptoms such as reduced emotional response and social withdrawal, and cognitive symptoms affecting memory and attention.

Trial ID:

2025-521215-39-00

Protocol code:

NBI-1117568-SCZ3030

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?