Gaithersburg, MDNCT07734493Now EnrollingIRB Ready

Schizophrenia Clinical Trial in Gaithersburg, MD

Access cutting-edge schizophrenia treatment through this phase 1 clinical trial at a research site in Gaithersburg. Study-provided care at no cost to qualified participants.

Sponsored by Leal Therapeutics, Inc

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Expert Care in Gaithersburg

Access schizophrenia specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related schizophrenia treatment provided free

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Check if you qualify for this schizophrenia clinical trial in Gaithersburg, MD

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Gaithersburg

    Convenient for MD residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Gaithersburg site if eligible
  4. 4Begin participation

About This Schizophrenia Study in Gaithersburg

The purpose of this clinical trial is to learn whether the investigational drug LTX-001 is safe and well tolerated in adults with a diagnosis of schizophrenia who are having a recent worsening of their symptoms (an acute exacerbation). Additional questions it aims to answer are: * how does the amount of the study drug in the body change over time (pharmacokinetics) * how does the study drug affect the symptoms of schizophrenia * how do certain markers in the blood change after administration of LTX-001 (pharmacodynamics) Researchers will compare different dose levels of LTX-001 to an inactive product (placebo) to see what differences there are between the two treatments. After successfully screening for the study, participants will stay in a research unit for about five weeks and return one week later for a follow-up visit.

Sponsor: Leal Therapeutics, Inc

Who Can Participate

Inclusion Criteria

BMI \> 17.5 and \< 38.0 kg/m2 and a total body weight \> 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

Exclusion Criteria

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Gaithersburg?

Yes, this clinical trial (NCT07734493) has an active research site in Gaithersburg, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Schizophrenia Treatment Options in Gaithersburg, MD

If you're searching for schizophrenia treatment options in Gaithersburg, MD, this clinical trial (NCT07734493) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Gaithersburg research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced schizophrenia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all schizophrenia clinical trials near you to find additional studies recruiting in your area.

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