Iloperidone for Schizophrenia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a long-acting injection of iloperidone can prevent worsening symptoms in people with schizophrenia. Participants will begin with iloperidone tablets and then switch to injections, with some receiving a placebo (inactive substance) for comparison. The trial seeks individuals diagnosed with schizophrenia who require ongoing psychiatric treatment. As a Phase 3 trial, this treatment is in the final step before FDA approval, offering participants an opportunity to contribute to a potentially groundbreaking therapy.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that iloperidone is generally safe and effective for treating schizophrenia. Studies found it to be as effective as haloperidol in preventing relapses over time.
Reported side effects are usually mild to moderate and include dizziness, dry mouth, and sleepiness. However, there is a more serious risk of heart problems, making regular check-ups important. Additionally, there is a warning about a higher risk of death in older adults with dementia-related psychosis.
Overall, many patients have safely used iloperidone, but discussing any concerns with a healthcare provider is important.12345Why do researchers think this study treatment might be promising?
Researchers are excited about iloperidone for schizophrenia because it offers a unique delivery method. Unlike the oral medications that are commonly used, iloperidone is available as a long-acting intramuscular injection. This could mean fewer doses and potentially improved adherence for patients. Additionally, iloperidone has a distinct mechanism of action, targeting specific receptors in the brain to help manage symptoms, which might offer benefits over existing antipsychotic options like risperidone and olanzapine.
What evidence suggests that iloperidone might be an effective treatment for schizophrenia?
Research has shown that iloperidone can help manage symptoms of schizophrenia. One study found that a daily dose of 12 mg significantly improved scores on a test measuring psychiatric symptoms compared to a placebo. Another study demonstrated that iloperidone improved overall schizophrenia symptoms based on a scale assessing symptom severity. Additionally, doses between 10-24 mg proved similarly effective, offering flexibility in dosing. These studies support the idea that iloperidone can be a useful treatment for schizophrenia. In this trial, participants will initially receive iloperidone during a 12-week stabilization phase, followed by randomization to receive either iloperidone long-acting injection or a matching placebo for up to 52 weeks.26789
Are You a Good Fit for This Trial?
This trial is for individuals who have been diagnosed with schizophrenia according to DSM-5 criteria and require continuous psychiatric treatment. Specific details on exclusion criteria are not provided, but typically these would include factors that could interfere with the study or patient safety.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Stabilization
Participants receive open-label iloperidone administered as oral tablets
Relapse Prevention
Participants receive open-label iloperidone as long-acting intramuscular injections
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Iloperidone
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanda Pharmaceuticals
Lead Sponsor