Fort Myers, FLNCT06372964Now EnrollingIRB Ready

Bipolar Depression Clinical Trial in Fort Myers, FL

Access cutting-edge bipolar depression treatment through this phase 3 clinical trial at a research site in Fort Myers. Study-provided care at no cost to qualified participants.

Sponsored by Intra-Cellular Therapies, Inc.

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Expert Care in Fort Myers

Access bipolar depression specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related bipolar depression treatment provided free

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Check if you qualify for this bipolar depression clinical trial in Fort Myers, FL

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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 Fort Myers

    Convenient for FL 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 Fort Myers site if eligible
  4. 4Begin participation

About This Bipolar Depression Study in Fort Myers

This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).

Sponsor: Intra-Cellular Therapies, Inc.

Who Can Participate

Inclusion Criteria

Able to provide consent as follows:
The Legally Authorized Representative (LAR) must provide written, informed consent.
The patient must provide written assent;
Male or female patients 10 to 17 years of age, inclusive;
Have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of bipolar I or bipolar II disorder with a current MDE without psychosis as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL);
Subject has a lifetime history of at least one manic or hypomanic episode.
Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration;
CDRS-R total score ≥ 45 with ≥ 5 on Item 11 (depressed feelings) at Screening and Baseline;
Young Mania Rating Scale (YMRS) score ≤ 15 (with YMRS Item 1 \[elevated mood\] score ≤ 2) at Screening and Baseline.

Exclusion Criteria

Has a primary psychiatric diagnosis other than bipolar I or bipolar II disorder. Exception includes:
Attention deficit hyperactivity disorder (ADHD). If a subject is taking medications for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study.
Intellectual disability based on Investigator opinion and DSM-5 criteria
Patient has been hospitalized for a bipolar manic episode within the 30 days prior to randomization;
Demonstrates a ≥ 25% decrease (improvement) in the CDRS-R total score between Screening and Baseline visits, or the CDRS-R is below 45 at 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 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 3, 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; or
At Screening or Baseline, scores \> 3 on Item 13 (suicidal ideation) on the CDRS-R; or
The patient is considered to be an imminent danger to him/herself or others.

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 Fort Myers?

Yes, this clinical trial (NCT06372964) has an active research site in Fort Myers, FL 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.

Bipolar Depression Treatment Options in Fort Myers, FL

If you're searching for bipolar depression treatment options in Fort Myers, FL, this clinical trial (NCT06372964) 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 Fort Myers research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced bipolar depression 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 bipolar depression clinical trials near you to find additional studies recruiting in your area.

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