New York, NYNCT07799493Now EnrollingIRB Ready

Social Anxiety Disorder (SAD) Clinical Trial in New York, NY

Access cutting-edge social anxiety disorder (sad) treatment through this phase 4 clinical trial at a research site in New York. Study-provided care at no cost to qualified participants.

Sponsored by Jason Careri

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Expert Care in New York

Access social anxiety disorder (sad) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related social anxiety disorder (sad) treatment provided free

Apply for This New York Location

Check if you qualify for this social anxiety disorder (sad) clinical trial in New York, NY

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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 New York

    Convenient for NY 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 New York site if eligible
  4. 4Begin participation

About This Social Anxiety Disorder (SAD) Study in New York

The goal of this clinical trial is to learn if Caplyta works to treat Social Anxiety Disorder in adults. The main question it aims to answer is: Does Caplyta lower the frequency/severity of social anxiety symptoms in adults? Researchers will compare Caplyta to a placebo (a look-alike substance that contains no drug) to see if Caplyta works to treat Social Anxiety Disorder. Participants will: Take Caplyta or a placebo every day for 8 weeks Visit the clinic once every week for checkups and tests

Sponsor: Jason Careri

Who Can Participate

Inclusion Criteria

Male and female adults between 18 and 65 years of age (inclusive).
Written informed consent given prior to any study procedures.
Diagnosis of Social Anxiety Disorder (SAD) according to DSM-5 criteria, as determined by psychiatric evaluation with the Investigator and as confirmed by the MINI at Screening.
Minimum total score of 70 on the LSAS at Screening and Baseline visits.
Total Hamilton Depression Rating Scale (HAM-D) score of less than 16 at Screening and Baseline.
Clinical Global Impression of Severity (CGI-S) score of 4 or greater at Screening and Baseline.
All subjects of childbearing potential must commit to an effective form of contraception for the duration of the trial and for at least 4 weeks after it ends. Effective forms of contraception include: condoms with spermicide, diaphragm with spermicide, hormonal contraceptive agents (oral, transdermal, or injectable), or implantable contraceptive devices. Abstinence from heterosexual intercourse will also be considered an effective form of contraception, if abstinence is part of the subject's usual lifestyle.

Exclusion Criteria

Subjects with a history of treatment refractory SAD, defined for this study as: a history of two or more failed treatment trials, with an FDA-approved SAD treatment, whereby a treatment trial is defined as a period of at least 6 weeks during which the subject received an adequate dosage of the SAD treatment. The minimum adequate dosage of FDA-approved SAD treatments is defined as follows: Paxil®/paroxetine: 20 mg Zoloft®/sertraline: 100 mg Effexor XR®/venlafaxine: 150 mg Luvox®/fluvoxamine: 100 mg
Subjects with any Axis I disorder other than SAD (e.g., post-traumatic stress disorder, obsessive compulsive disorder, panic disorder) within 24 weeks of the Baseline visit. Subjects with co-morbid MDD, GAD, dysthymia, ADHD, or specific phobias may be allowed if SAD is the primary disorder in terms of clinical severity, as determined by the investigator.
Subjects with any history or complication of schizophrenia or bipolar disorder.
Subjects with a complication of body dysmorphic disorder.
Subjects who are at risk of suicide, including: Subjects scoring \>2 on item #3 of the HAM-D at Screening or Baseline Subjects with recent (within the last 6 months prior to screening) suicidal behavior, defined as scoring "yes" on items 4 or 5 in the Suicidal Ideation section of the C-SSRS at Screening or Baseline Subjects who, in the opinion of the investigator, are at significant risk of suicide or suicidal behavior during the course of study participation Subjects with any suicide attempt within the 6 months prior to screening
Substance use disorder, as defined by DSM-5 criteria, within 24 weeks of Baseline.
Positive Urine Drug Screen at Baseline, unless due to prescribed medication.
Systolic blood pressure ≥165 and/or diastolic blood pressure ≥95, as measured at Screening and Baseline visits.
Current diagnosis of Diabetes Mellitus (type 1 or 2).
Current diagnosis or past history of significant cardiovascular disease.
Current hepatic impairment, including screening laboratory results showing: transaminases (ALT or AST) greater than 2 times the upper limit of normal (ULN), absolute neutrophil count (ANC) \< 1000, or active Hepatitis B or Hepatitis C.
Subjects with a history or complication of cancer or malignant tumor not in remission for at least 5 years. Basal cell skin cancers are not exclusionary.
Any history of seizure or seizure disorder, with the exception of a single childhood febrile seizure.
Any current unstable and/or clinically significant medical condition, based on history or as evidenced in screening laboratory results or ECG assessments.
Subjects with known hypersensitivity or allergy to lumateperone, or for whom Caplyta® is otherwise contraindicated.
Subjects receiving a moderate or strong CYP3A4 inhibitor, or any CYP3A4 inducer.
Subjects receiving fluoxetine within 28 days of Baseline.
Subjects receiving a MAO inhibitor within 14 days of the Baseline visit.
Subjects receiving any other psychotropics within 14 days of Baseline (including but not limited to: gabapentin, pregabalin, antipsychotics, SSRIs, SNRIs, benzodiazepines, and sedative hypnotics other than zolpidem). Zolpidem (Ambien®) PRN is allowed for insomnia, if not taken more than 3 times per week. Subjects on a stable dose of a beta-blocker for hypertension (stable for at least six months prior to Baseline) are not excluded from study participation.
Subjects who started psychotherapy or Cognitive Behavioral Therapy (CBT) within 24 weeks of Screening, except for supportive psychotherapy. Subjects who have been receiving psychotherapy or CBT for more than 24 weeks prior to Screening are eligible for the study, provided that the therapy continues at the same frequency for the duration of the trial.
Subjects who have received any electroconvulsive therapy (ECT) within 12 weeks of Baseline.
Subjects who are currently pregnant, lactating, or of childbearing potential and not able and willing to practice an effective method of contraception for the duration of the trial and at least 4 weeks after the final study visit.

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 (NCT07799493) 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.

Social Anxiety Disorder (SAD) Treatment Options in New York, NY

If you're searching for social anxiety disorder (sad) treatment options in New York, NY, this clinical trial (NCT07799493) 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 phase 4 clinical trial. You'll receive care from experienced social anxiety disorder (sad) 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 social anxiety disorder (sad) clinical trials near you to find additional studies recruiting in your area.

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