Is NCT07807865 recruiting in Brooklyn, NY?

Yes, NCT07807865 is currently recruiting participants at its Brooklyn, NY location. This generalized anxiety disorder clinical trial is actively enrolling qualified participants.

How do I join the generalized anxiety disorder clinical trial in Brooklyn?

To join this clinical trial in Brooklyn, 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 Brooklyn 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.

Generalized Anxiety Disorder Clinical Trial in Brooklyn, NY

About This Generalized Anxiety Disorder Study in Brooklyn

The purpose of this study is to assess how safe ITI-1284 is and how well it can be tolerated in long-term, when given alone or with other medicines, in participants with generalized anxiety disorder (GAD) who have not responded to treatment previously. GAD is a mental health condition defined by constant, uncontrollable worry about everyday things that lasts for six months or more.

Sponsor: Intra-Cellular Therapies, Inc.

Who Can Participate

Inclusion Criteria

for Roll-over participants:

Provide written informed consent before the initiation of any study specific procedures

Is currently an outpatient, and is anticipated to maintain outpatient status for the duration of the study

Male or female of childbearing potential and agrees to use a highly effective method of birth control from the time informed consent is provided until 30 days after the last dose of ITI-1284 for females and 90 days after the last dose of ITI-1284 for males

Ability to follow study instructions and likely to complete all required visits

In the opinion of the Investigator, the patient must have safely completed the lead-in study (ITI-1284-301 or ITI-1284-302)

If entering from lead-in study ITI-1284-301, must be expected to continue their ongoing anti-depressant therapy (ADT) or buspirone from the lead-in study Inclusion criteria for De-novo participants:

Provide written informed consent before the initiation of any study-specific procedures

Male or female participants greater than or equal to (\>=) 18 years of age

Has a body mass index (BMI) of 19-40 kilogram per meter squared (kg/m\^2), inclusive

At screening, meet diagnostic and statistical manual of mental disorders, fifth edition, text revision (DSM-5-TR) diagnostic criteria for moderate or severe generalized anxiety disorder (GAD) (current GAD) as confirmed by the investigator or sponsor-approved rater using the structured clinical interview for DSM-5, clinical trials version (SCID 5-CT)

Is currently an outpatient, and is anticipated to maintain outpatient status for the duration of the study

Exclusion Criteria

for Roll-over participants

In the opinion of the Investigator, the participant has a significant risk for suicidal behavior during the course of her/his participation in the study or is considered to be an imminent danger to her/himself or others, and/or: a. At baseline, the participant scores "yes" on suicidal Ideation Items 4 or 5 of the Columbia-suicide severity rating scale (C-SSRS) "Since Last Visit" version; b. At baseline, the participant scores \>= 5 on the Montgomery-Asberg depression rating scale (MADRS) Item 10 (suicidal Thoughts); c. The participant is considered to be an imminent danger to themself or others based on the assessment of the Investigator

The participant is breast-feeding or pregnant; female participants of childbearing potential must have a negative urine pregnancy test at baseline

Based on the Investigator's clinical judgement, any abnormal clinical laboratory test or electrocardiogram (ECG) results obtained throughout the lead-in study that are considered clinically significant and preclude safe participation in the study

The participant has any other condition that may be detrimental to the participant if they participate in the study

In the opinion of the Investigator, the participant is unable to comply with study procedures or judged to be inappropriate for the study Exclusion criteria for De-novo participants

Within the participant's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses: a. schizophrenia, schizoaffective disorder, schizophreniform disorder or other psychotic disorder; b. bipolar disorder

Within 6 months of screening, has a confirmed DSM-5-TR psychiatric diagnosis other than GAD, including: a. other anxiety disorders; b. moderate or severe alcohol or substance use disorders; c. moderate or severe major depressive disorder (MDD)

MADRS total score greater than (\>) 18 at screening or baseline

The participant has received electroconvulsive therapy (ECT) or vagal nerve stimulation within the past 5 years, or repetitive trans cranial magnetic stimulation within the last 2 years, or had a failure in response to ECT at any time

The participant has known hypersensitivity or intolerance to ITI-007 (lumateperone), ITI-1284, or to any of the excipients

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 Brooklyn?

Yes, this clinical trial (NCT07807865) has an active research site in Brooklyn, 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.

Generalized Anxiety Disorder Treatment Options in Brooklyn, NY

If you're searching for generalized anxiety disorder treatment options in Brooklyn, NY, this clinical trial (NCT07807865) 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 Brooklyn research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced generalized anxiety 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 generalized anxiety disorder clinical trials near you to find additional studies recruiting in your area.

Generalized Anxiety Disorder Clinical Trial in Brooklyn, NY

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