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A Study of LTX-001 In Adult Participants With Acute Exacerbation of Schizophrenia

Research on LTX-001 for adults with schizophrenia flare-ups.

Recruiting
18-55 years
All
Phase 1
This study investigates LTX-001, a new medication for adults with schizophrenia, a mental disorder affecting thoughts, feelings, and behaviors. **Schizophrenia** can sometimes worsen suddenly, called an **acute exacerbation**. The study will find out if LTX-001 is safe and effective, and compare it to a placebo, an inactive substance. Participants will stay in a research unit for about five weeks and return for a follow-up visit one week later. During the study, doctors will check heart function with an **electrocardiogram (ECG)**, examine the nervous system, and collect blood and urine. Psychiatric tests, like the **Positive and Negative Syndrome Scale (PANSS)**, will assess symptoms. Participants must be adults not currently taking antipsychotic medication or willing to stop these before the study. They should not have significant health issues or substance use problems. **Key Points:** - The study lasts approximately 6 weeks, including a 5-week stay. - Participants will undergo various medical and psychiatric assessments. - Eligibility requires no current antipsychotic use and a willingness to use contraception. This trial is crucial for understanding if LTX-001 can help manage schizophrenia symptoms safely.
Study details
    Schizophrenia

NCT07734493

Leal Therapeutics, Inc

17 October 2026

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