โšกYour ready-to-use recruitment solution: IRB-compliant, SEO-optimized website that automatically routes qualified patient leads to your clinical study (14-day free trial, then $44/mo)

NCT04777357RECRUITINGIRB Ready

A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.

(3112 Ped BPD)

Sponsored by AbbVie

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 380 participants interested
0% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States. The treatment of the depressive episodes of bipolar disorder in the pediatric population has not been as widely studied as the treatment of depressive episodes in bipolar disorder in adults, therefore pharmacotherapeutic options are limited.

Who Can Participate

Inclusion Criteria

Participants with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) primary diagnosis of bipolar I disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).
Current depressive episode is more than 2 weeks and less than 12 months in duration.
Participant has a lifetime history of at least one manic episode.
Children's Depression Rating Scale - Revised (CDRS-R) score \> = 45 at Visit 1 and Visit 2.
Young-Mania Rating Scale (YMRS) score \< = 12 with YMRS Item 1 (elevated mood) score \< = 2 at Visit 1 and Visit 2.
Clinical Global Impression-Severity (CGI-S) scale score of \> = 4 (moderately ill) at Visit 1 and Visit 2.

Exclusion Criteria

Participants with DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder due to another medical condition, PTSD, antisocial p

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

380 participants

๐ŸŽ‚

Age Range

10 Years - 17 Years

โšง

Gender

ALL

๐Ÿข

Sponsor

AbbVie

Study Locations

Choose your preferred location or select flexible during enrollment

COMPLETED

Bentonville

Arkansas

Location available
View Bentonville location page
RECRUITING

Anaheim

California

Location available
View Anaheim location page
COMPLETED

Beverly Hills

California

Location available
View Beverly Hills location page
COMPLETED

Culver City

California

Location available
View Culver City location page
COMPLETED

Garden Grove

California

Location available
View Garden Grove location page
COMPLETED

Long Beach

California

Location available
View Long Beach location page
RECRUITING

Orange

California

Location available
View Orange location page
RECRUITING

Orange

California

Location available
View Orange location page
COMPLETED

Rancho Cucamonga

California

Location available
View Rancho Cucamonga location page

๐Ÿ“ And 54 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Bipolar I Disorder Treatment in Bentonville?

Join others in Arkansas exploring innovative treatment options through clinical research

Bipolar I Disorder Treatment Options in Bentonville, Arkansas

If you're searching for Bipolar I Disorder treatment in Bentonville, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Bentonville, Anaheim, Beverly Hills and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Bipolar I Disorder. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Arkansas
Now Enrolling
Up to 380 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Bipolar I Disorder?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Bipolar I Disorder

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Bipolar I Disorder Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT04777357. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.