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NCT03817502RECRUITINGIRB Ready

Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia

Sponsored by Gedeon Richter Plc.

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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

The purpose of this study is to evaluate the efficacy and safety of cariprazine in the treatment of schizophrenia in the adolescent population.

Who Can Participate

Inclusion Criteria

DSM-5 primary diagnosis of schizophrenia.
Schizophrenia diagnosis confirmed by the K-SADS-PL administered at screening (Visit 1) by a trained clinician.
PANSS score โ‰ฅ 70 and a score of โ‰ฅ 4 (moderate) on 2 or more of the 5 items on the positive subscale of the PANSS (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/persecution), at screening (Visit 1) and baseline (Visit 2).
CGI-S scale score of โ‰ฅ 4 (moderately ill) at screening (Visit 1) and baseline (Visit 2).

Exclusion Criteria

Current diagnosis of bipolar disorder, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition
Diagnosis of intellectual disability (IQ \< 70).
Participant has a history of meeting DSM-5 diagnosis for any substance-related disorder (except caffeine- and tobacco-related) within the 3 months before Visit 1.

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

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

330 participants

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Age Range

13 Years - 17 Years

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Gender

ALL

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Sponsor

Gedeon Richter Plc.

Study Locations

Choose your preferred location or select flexible during enrollment

COMPLETED

Culver City

California

Location available
View Culver City location page
COMPLETED

Atlanta

Georgia

Location available
View Atlanta location page
WITHDRAWN

Atlanta

Georgia

Location available
View Atlanta location page
WITHDRAWN

Bloomfield Hills

Michigan

Location available
View Bloomfield Hills location page
WITHDRAWN

Flowood

Mississippi

Location available
View Flowood location page
WITHDRAWN

Buffalo

New York

Location available
View Buffalo location page
WITHDRAWN

New York

New York

Location available
View New York location page
COMPLETED

Cincinnati

Ohio

Location available
View Cincinnati location page
COMPLETED

The Woodlands

Texas

Location available
View The Woodlands location page

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 Schizophrenia Treatment in Culver City?

Join others in California exploring innovative treatment options through clinical research

Schizophrenia Treatment Options in Culver City, California

If you're searching for Schizophrenia treatment in Culver City, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Culver City, Atlanta, Atlanta 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 Schizophrenia. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 330 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Schizophrenia?

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 Schizophrenia

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 Schizophrenia 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: NCT03817502. 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.