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Study on the Effectiveness and Safety of SEP-363856 for Patients with Acute Schizophrenia Symptoms

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called SEP-363856 in individuals experiencing acute psychotic episodes related to schizophrenia. Schizophrenia is a mental health condition that can cause symptoms such as hallucinations, delusions, and disorganized thinking. The medication being tested, SEP-363856, contains an active substance known as ulotaront and is administered in tablet form.

The purpose of the study is to evaluate how effective and safe SEP-363856 is for treating acute psychotic symptoms in people with schizophrenia. Participants in the study will be randomly assigned to receive either a fixed dose of SEP-363856 or a placebo. The study will begin with a double-blind phase, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This phase will last for six weeks. After this, there will be an open-label extension phase where all participants will have the opportunity to receive SEP-363856.

Throughout the study, participants will be monitored to assess changes in their symptoms using a tool called the Positive and Negative Syndrome Scale (PANSS), which measures the severity of schizophrenia symptoms. The study aims to determine if SEP-363856 can help reduce these symptoms and improve the overall condition of those affected by schizophrenia.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be asked to provide written informed consent. This means you agree to participate after understanding the study's goals, procedures, and potential risks and benefits.
Step 2
Initial assessment
You will undergo an initial assessment to confirm your eligibility. This includes a clinical interview to ensure you meet the criteria for schizophrenia and other necessary evaluations.
Step 3
Double-blind phase
During this phase, you will receive either the study medication, SEP-363856, or a placebo. The medication is taken orally in the form of a tablet.
You will be assigned a fixed dose of either 50 mg or 75 mg per day. This phase lasts for 6 weeks.
Step 4
Regular monitoring
Throughout the double-blind phase, you will have regular visits to monitor your health and response to the treatment. This includes assessments of your symptoms using the Positive and Negative Syndrome Scale (PANSS) and other evaluations.
Step 5
End of double-blind phase
At the end of the 6-week double-blind phase, your progress will be evaluated. This includes a final assessment of your symptoms and overall health.
Step 6
Open-label extension phase
If you complete the double-blind phase, you may enter the open-label extension phase. In this phase, all participants receive the study medication, SEP-363856, and no placebo is used.
You will continue to take the medication as prescribed and attend regular follow-up visits for ongoing monitoring.

Who can join the trial?

10 criteria

Must be fully informed about the study's goals, procedures, and possible benefits and risks, and provide written consent to participate. If the participant is a minor, a guardian must also give consent.
Must be a male or female between the ages of 18 and 65.
Must have a diagnosis of schizophrenia according to the DSM-5 criteria, confirmed by a clinical interview.
Must have a CGI-S score of 4 or higher, indicating they are moderately ill.
Must have a PANSS total score of 80 or higher, and a score of 4 or higher on at least two specific symptoms: delusions, conceptual disorganization, hallucinations, or unusual thought content.
Must be experiencing an acute exacerbation of psychotic symptoms, which means a sudden worsening of symptoms, lasting no longer than 2 months before giving consent. This includes a noticeable decline in work, social life, or personal care. If hospitalized for this reason, the stay must not exceed 2 weeks before the screening.
Participants with more than 3 previous hospitalizations for acute schizophrenia may join only with approval from the Medical Monitor.
For the open-label phase: Must have completed the 6-week treatment and all assessments in the double-blind phase.
Female participants who can become pregnant must have a negative pregnancy test and agree to use reliable birth control during the study and for 30 days after the last dose.
Male participants must agree to use effective birth control methods to prevent fathering a child from the start of the study until 30 days after the last dose.

Who cannot join the trial?

4 criteria

Patients who are not experiencing an acute psychotic episode related to schizophrenia cannot participate. An acute psychotic episode is a sudden and severe mental disturbance where a person may lose touch with reality.
Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study and may vary.
Patients who are not part of the specified clinical trial group cannot participate. This group is defined by the study and includes specific characteristics or conditions.
Patients who are not able to provide informed consent or who are considered part of a vulnerable population may not be eligible. A vulnerable population includes individuals who may have limited ability to make informed decisions about their participation.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Institutul De Psihiatrie Socola Lasi
Iasi, Romania
Verified
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Bucharest, Romania
Verified
Spitalul Clinic De Psihiatrie Si Neurologie Brasov
Brasov, Romania

Trial locations

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Investigated drugs

SEP-363856 is a medication being studied for its potential to help people with schizophrenia who are experiencing acute psychotic episodes. Schizophrenia is a mental health condition that can cause symptoms like hallucinations, delusions, and disorganized thinking. This medication is being tested to see if it can reduce these symptoms and improve the overall mental state of patients. The study aims to determine how effective and safe this medication is for treating schizophrenia by comparing it to a placebo, which is a substance with no active ingredients. The goal is to see if patients taking SEP-363856 show significant improvement in their symptoms compared to those who do not receive the active medication.

Ulotaront

What is already known about the treatment

SEP-363856 – SEP-363856 is a medication administered orally in the form of tablets, designed to help people with schizophrenia who are experiencing acute psychotic episodes. It is currently being studied in clinical trials to determine its effectiveness and safety, with promising results in reducing symptoms as measured by a specific scale used for schizophrenia. The medication works by affecting certain chemicals in the brain that are involved in mood and perception, although its exact mechanism at the molecular level is still being explored. It is classified as an antipsychotic drug, which is a type of medication used to manage symptoms of psychosis, including delusions and hallucinations.

Investigated diseases

Schizophrenia – Schizophrenia is a chronic mental disorder characterized by episodes of psychosis, which include hallucinations, delusions, and disorganized thinking. It affects how a person thinks, feels, and behaves, often leading to impaired functioning in daily life. The progression of schizophrenia can vary, with some individuals experiencing acute episodes followed by periods of remission, while others may have a more continuous course. Symptoms are typically categorized into positive symptoms, such as hallucinations and delusions, and negative symptoms, such as lack of motivation and social withdrawal. Cognitive symptoms, including difficulties with attention, memory, and problem-solving, may also be present. The onset of schizophrenia usually occurs in late adolescence or early adulthood.