Clinical trial for Schizophrenia
Official title A Study of LTX-001 In Adult Participants With Acute Exacerbation of Schizophrenia
ClinicalTrials.gov ID: NCT07734493
What this study is testing
What is LTX-001 once daily?
LTX-001 once daily is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for schizophrenia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out if LTX-001 is safe and well tolerated, how it moves through the body, and how it affects symptoms and blood markers in people with an acute flare of schizophrenia.
- Who it's for
- Adults diagnosed with schizophrenia who are experiencing a recent worsening of their symptoms.
- What's involved
- Participants will be randomly given different doses of LTX-001 or a placebo, stay in a research unit for about five weeks, and have regular monitoring and blood tests. One week after leaving the unit, they will return for a follow‑up visit.
- Time commitment
- The trial lasts about six weeks total, with a five‑week inpatient stay and a single follow‑up visit one week later.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- BMI \> 17.5 and \ 50.0 kg (110 lbs)
- Primary diagnosis of schizophrenia per the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5-TR)
- Experiencing an acute exacerbation or relapse of symptoms, with onset less than 2 months prior to screening for the study
- PANSS total score ≥ 80 at the time of screening for the study
- Not currently on antipsychotic medication, or is willing to discontinue all prohibited psychotropic medications prior to and during the trial period
You likely can't join if
- Evidence of organ dysfunction or any clinically significant abnormal finding at physical examination
- History of treatment resistance (e.g., failure to respond to ≥ 2 adequate antipsychotic trials) or failure to respond to use of clozapine
- Current DSM-5-TR diagnosis other than schizophrenia
- Pregnant or lactating female
- Substance use disorder within 1 year prior to screening or recreational use of drugs within 3 months prior to screening
- Moderate to severe alcohol use disorder as per DSM-5-TR within the past year or excessive use of alcohol within 12 months prior to screening
See the full eligibility criteria
- BMI \> 17.5 and \ 50.0 kg (110 lbs)
- Primary diagnosis of schizophrenia per the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5-TR)
- Experiencing an acute exacerbation or relapse of symptoms, with onset less than 2 months prior to screening for the study
- PANSS total score ≥ 80 at the time of screening for the study
- Not currently on antipsychotic medication, or is willing to discontinue all prohibited psychotropic medications prior to and during the trial period
- Sexually active adults must be willing to use an acceptable contraceptive method throughout the study
- Evidence of organ dysfunction or any clinically significant abnormal finding at physical examination
- History of treatment resistance (e.g., failure to respond to ≥ 2 adequate antipsychotic trials) or failure to respond to use of clozapine
- Current DSM-5-TR diagnosis other than schizophrenia
- Pregnant or lactating female
- Substance use disorder within 1 year prior to screening or recreational use of drugs within 3 months prior to screening
- Moderate to severe alcohol use disorder as per DSM-5-TR within the past year or excessive use of alcohol within 12 months prior to screening
- Positive testing for human immunodeficiency virus (HIV)-1 and -2 antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody at screening
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Los Alamitos, California, United States
- DeLand, Florida, United States
- Hollywood, Florida, United States
- Miami Lakes, Florida, United States
- Decatur, Georgia, United States
- Gaithersburg, Maryland, United States
- Marlton, New Jersey, United States
- Richardson, Texas, United States
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here - ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Los Alamitos, California, United States; DeLand, Florida, United States; Hollywood, Florida, United States; Miami Lakes, Florida, United States; Decatur, Georgia, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.