Lemon Grove, CANCT06480383Now EnrollingIRB Ready

Generalized Anxiety Disorder Clinical Trial in Lemon Grove, CA

Access cutting-edge generalized anxiety disorder treatment through this phase 2 clinical trial at a research site in Lemon Grove. Study-provided care at no cost to qualified participants.

Sponsored by Intra-Cellular Therapies, Inc.

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Expert Care in Lemon Grove

Access generalized anxiety disorder specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related generalized anxiety disorder treatment provided free

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Check if you qualify for this generalized anxiety disorder clinical trial in Lemon Grove, CA

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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 Lemon Grove

    Convenient for CA 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 Lemon Grove site if eligible
  4. 4Begin participation

About This Generalized Anxiety Disorder Study in Lemon Grove

This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo as adjunctive therapy to GAD treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD who have an inadequate response to ongoing GAD treatment.

Sponsor: Intra-Cellular Therapies, Inc.

Who Can Participate

Inclusion Criteria

Provide written informed consent before the initiation of any study specific procedures;
Male or female patients ≥ 18 years of age;
At Screening, meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) diagnostic criteria for moderate or severe 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), and meets all of the following at Screening and Baseline:
HAM-A Total score of ≥ 22;
HAM-A Items 1 (anxious mood) and 2 (tension) scores ≥ 2;
CGI-S score of ≥ 4;
History of inadequate response (\< 50% improvement in anxiety symptoms as measured by the modified Antidepressant Treatment Response Questionnaire \[ATRQ\] for GAD) to at least 1 GAD-approved treatment (ie, one of the following GAD-approved treatments: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone) taken at an adequate dose (at least a minimum total daily dose of paroxetine 20 milligrams \[mg\], venlafaxine XR 75 mg, duloxetine 60 mg, escitalopram 10 mg, or buspirone 20 mg) and duration (ie, daily for at least 6 weeks) for the treatment of ongoing GAD symptoms;
Currently having an inadequate response to one of the following GAD-approved treatments: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone taken at an adequate dose (at least a minimum total daily dose of paroxetine 20 mg, venlafaxine XR 75 mg, duloxetine 60 mg, escitalopram 10 mg, or buspirone 20 mg) and duration (ie, for at least 6 weeks prior to Screening) and agrees to continue the same dosing regimen for the duration of the study. NOTE: The current GAD-approved treatment must be different from the GAD treatment identified as the historical failure.

Exclusion Criteria

Within the patient's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses:
Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;
Bipolar Disorder;
MADRS total score \> 18 at Screening or Baseline;
In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or
At Screening, the patient scores "yes" on Suicidal Ideation Items 4 or 5 of the C-SSRS within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 4 or 5 since the Screening Visit;
At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening;
At Screening or Baseline MADRS Item 10 score ≥ 5; or
The patient is considered to be an imminent danger to him/herself or others based on the assessment of the Investigator.
Lifetime history of failure to respond to \> 3 of the approved treatments for GAD (ie, paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone) at an adequate dose (at least a minimum total daily dose of paroxetine 20 mg, venlafaxine XR 75 mg, duloxetine 60 mg, escitalopram 10 mg, or buspirone 20 mg) and for an adequate duration (ie, at least 6 weeks).

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 Lemon Grove?

Yes, this clinical trial (NCT06480383) has an active research site in Lemon Grove, CA 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 Lemon Grove, CA

If you're searching for generalized anxiety disorder treatment options in Lemon Grove, CA, this clinical trial (NCT06480383) 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 Lemon Grove research site is actively enrolling participants for this phase 2 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.

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