NCT05648591 · Vanda Pharmaceuticals
Safety and Tolerability of Open-Labeled Iloperidone in Adolescents
What this study is about
To evaluate the safety and how well patients handle the treatment of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment.
View original scientific description
To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment.
Interventions
DRUG
Iloperidone
oral tablet
Primary outcome measures
Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period.
Time frame: 1 year
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patient is willing and able to provide assent and willing to complete all aspects of the study
- Patient's parent or legal guardian willing and able to provide consent
- Male or female patients 12 through 17 years of age (inclusive)
- Clinical diagnosis of either schizophrenia or bipolar I disorder
Exclusion criteria
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
- A positive test for drugs of abuse
Where
- Little Rock, Arkansas
- Denver, Colorado
- Atlanta, Georgia
- Decatur, Georgia
- Cincinnati, Ohio
- Garfield Heights, Ohio
- Westlake, Ohio
- Everett, Washington
Related conditions & keywords
Frequently asked questions
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.
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.
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.
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.
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.
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.
Data: ClinicalTrials.gov · synced Mar 4, 2025 · Source of record for eligibility and locations