Is NCT07423546 recruiting in New York, NY?

Yes, NCT07423546 is currently recruiting participants at its New York, NY location. This schizophrenia 1 (disorder) clinical trial is actively enrolling qualified participants.

How do I join the schizophrenia 1 (disorder) clinical trial in New York?

To join this clinical trial in New York, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this New York clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

SCHIZOPHRENIA 1 (Disorder) Clinical Trial in New York, NY

About This SCHIZOPHRENIA 1 (Disorder) Study in New York

This is a single site clinical trial in which 12 participants with schizophrenia will be randomized to one of three doses of treatment with Cobenfy for 5 weeks. \[18F\]DOPA PET scans will be obtained before and after treatment to examine the effects of Cobenfy on dopamine transmission. The overall objective of the current study is to measure Cobenfy's ability to engage its putative target (DA transmission/synthesis capacity in the striatum and midbrain as measured by \[18F\]DOPA Kicer (\[18F\]DOPA relative uptake rate)).

Sponsor: New York State Psychiatric Institute

Who Can Participate

Inclusion Criteria

Individuals aged 18 to 50, inclusive at screen

Capable of understanding the study procedures and able to provide informed consent

Diagnosed with schizophrenia, schizoaffective, or schizophreniform disorder

Antipsychotic free at Visit 1 (by choice and for reasons unrelated to the study), and for at least 3 weeks (4 for aripiprazole, Cobenfy or LAIs) at the time of the baseline PET scan, inclusive of any antipsychotic-free time prior to consent

PANSS total score \> 80 and \< 120

Willing to use qualified methods of contraception (listed in section 5.3) for the study duration (for women of childbearing potential only)

Stable dosing of herbal/dietary supplements for at least 6 weeks at the time of the first dose of Cobenfy and willingness to avoid products with known hepatotoxic ingredients (e.g., green tea extract, kratom, ashwagandha).

Exclusion Criteria

Diagnosis of moderate or severe substance use disorder within the previous month (from first PET scan)

A history of poor or inadequate response to Cobenfy for any reason, hypersensitivity to Cobenfy or trospium or no justifiable reason to expect improvement on Cobenfy, or treatment with Cobenfy within 4 weeks of the first PET Scan

EKG abnormality that is clinically significant including a QT interval \> 450 msec for men and \> 470 msec for women, as corrected by the Fridericia formula (QTcF)

Pregnant or breast-feeding women. Women of child-bearing potential must have a negative serum β-hCG pregnancy test at Visit 1, must have been using an acceptable method of contraception (section 5.3) for 30 days before the study, and must agree to do so for the whole study and 30 days after (unless post-menopausal or surgically sterile)

Any clinically significant or unstable medical illness, condition, or disorder that is anticipated to potentially compromise participant safety on study medication, including (but not necessarily limited to) the following: urinary retention, moderate or severe hepatic impairment, gastric retention, untreated narrow-angle glaucoma, hypernasality, resting heart rate \>100 bpm or systolic Blood Pressure \>150 mmHg, a history of orthostatic hypotension or abnormal orthostatic blood pressure (change in mean arterial pressure \[1/3 systolic + 2/3 diastolic\] of \> 20% between supine and standing blood pressures), known human immunodeficiency virus (i.e., by history), cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, symptomatic gallstone disease, active hepatic infections, history of bladder stones, recurrent urinary tract infections, or International Prostate Symptom Score \> 7 or any one item \> 2 (not including the nocturia item).

Any material in the body that is a contraindication for MRI procedures or participated in prior nuclear medicine procedures in the past year that exceed FDA-defined limits when combined with radiation dosimetry from PET scanning in this protocol to avoid exceeding annual dosimetry limits (metal screener repeated before MRI scan during visit 2)

Participants with suicidal ideation with intent or plan (indicated by affirmative answers to items 4 or 5 of the Suicidal Ideation section of the baseline C-SSRS) in the past 1 month or suicidal behavior in the past 3 months

Laboratory abnormality that would compromise the well-being of the participant, including Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value \> 2 times the upper limit of the laboratory normal reference range, elevated bilirubin (i.e., \>2 x upper limit of normal (ULN)), or serum prostate specific antigen (PSA) \>10 ng/ml (for men only).

A history of treatment resistance to antipsychotics

Use of nicotine products within the previous month (prior to first PET scan)

History of significant violent behavior when antipsychotic-free or currently homicidal

Positive toxicology screen for any substances of abuse

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 New York?

Yes, this clinical trial (NCT07423546) has an active research site in New York, NY 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 1 (Disorder) Treatment Options in New York, NY

If you're searching for schizophrenia 1 (disorder) treatment options in New York, NY, this clinical trial (NCT07423546) 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 New York research site is actively enrolling participants for this clinical trial. You'll receive care from experienced schizophrenia 1 (disorder) 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 1 (disorder) clinical trials near you to find additional studies recruiting in your area.

SCHIZOPHRENIA 1 (Disorder) Clinical Trial in New York, NY

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