Iloperidone for Schizophrenia

Overseen By Vanda Pharmaceuticals Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Vanda Pharmaceuticals

Must be taking: Iloperidone

Disqualifiers: Other psychiatric disorders, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

1 Power Preferred Clinic 1 of this trial's clinic is considered top 20 on Power

Compensation: Varies

Number of Visits: Unknown

400 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{2 6 7 8 9}

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

I have been diagnosed with schizophrenia.

I am currently receiving treatment for a mental health condition.

Exclusion Criteria

Have you been treated for a psychiatric condition other than schizophrenia in the past 6 months?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stabilization

Participants receive open-label iloperidone administered as oral tablets

12-14 weeks

Relapse Prevention

Participants receive open-label iloperidone as long-acting intramuscular injections

Up to 54 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Iloperidone

Trial Overview The study is testing iloperidone in two forms: as a long-acting injection (LAI) and in oral form. The goal is to compare how the body handles both methods of delivering this medication in patients with schizophrenia.

How Is the Trial Designed?

Group I: iloperidone Experimental Treatment 1 Intervention

During the 12-week stabilization phase, all patients will receive open-label iloperidone administered as oral tablets (weeks 1-6) and as long-acting intramuscular injections (weeks 7-12). Subsequently, patients will be randomized in a 1:1 ratio to one of two arms: iloperidone long-acting injection or matching placebo. Post-randomization this arm will receive double-blind study drug (iloperidone long-acting injection) as long-acting intramuscular injections for up to 52 weeks.

Group II: placebo Placebo Group 1 Intervention

During the 12-week stabilization phase, all patients will receive open-label iloperidone administered as oral tablets (weeks 1-6) and as long-acting intramuscular injections (weeks 7-12). Subsequently, patients will be randomized in a 1:1 ratio to one of two arms: iloperidone long-acting injection or matching placebo. Post-randomization this arm will receive double-blind study drug (matching placebo) as long-acting intramuscular injections for up to 52 weeks.

Who Is Running the Clinical Trial?

Vanda Pharmaceuticals

Lead Sponsor

Trials

68

Recruited

19,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2810169/

Iloperidone (Fanapt): An FDA-Approved Treatment Option for ... In study 1, iloperidone 12 mg/day was significantly more effective than placebo in improving BPRS scores. In study 2:

2. fanaptpro.com fanaptpro.com/atypical-antipsychotic-efficacy

Atypical Antipsychotic Efficacy Fanapt significantly improved overall schizophrenia symptoms as measured by PANSS 1,2 Improvement in symptoms in a 4-week study 2

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01929889

Assessing the Effects of Fanapt® on Social Cognition ... The study looks at whether treatment with iloperidone (Fanapt) is associated with improvements in social cognition in individuals who have been recently ...

4. psychiatrist.com psychiatrist.com/jcp/efficacy-safety-iloperidone-in-bipolar-mania/

Efficacy and Safety of Iloperidone in Bipolar Mania At 4 weeks of treatment, patients receiving iloperidone showed significant improvement on the Young Mania Rating Scale versus those ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0920996411002945

Efficacy of iloperidone in schizophrenia: A PANSS five ... Iloperidone demonstrated positive treatment effects on these newly derived PANSS factors. The 10–16 mg and 20–24 mg dose groups had similar efficacy on the ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2016/022192s017lbl.pdf

FANAPT (iloperidone) tablets - accessdata.fda.gov Data from a placebo-controlled, 4-week, fixed-dose study, in which fasting blood samples were drawn, in adult subjects with schizophrenia are presented in Table ...

7. fanaptpro.com fanaptpro.com/wp-content/uploads/Fanapt-Prescribing-Information.pdf

Prescribing Information Based on the pooled data from 4 placebo-controlled, 4- or 6-week, fixed- or flexible-dose studies, adverse reactions in patients with schizophrenia that ...

8. mayoclinic.org mayoclinic.org/drugs-supplements/iloperidone-oral-route/description/drg-20072986

Iloperidone (oral route) - Side effects & dosage Iloperidone is used to treat schizophrenia. It is also used to treat manic ... Safety and efficacy have not been established. Geriatric. Appropriate ...

9. medcentral.com medcentral.com/drugs/monograph/153411-310007/iloperidone-oral

Iloperidone: uses, dosing, warnings, adverse events, ... The prescribing information for iloperidone contains a boxed warning about the risk of increased mortality in geriatric patients with dementia-related psychosis ...