Iloperidone Safety for Adolescent Schizophrenia

Recruiting at 12 trial locations

Overseen By Vanda Pharmaceuticals Inc.

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Vanda Pharmaceuticals

Must not be taking: Investigational drugs, Drugs of abuse

Disqualifiers: Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and tolerability of iloperidone in young people with schizophrenia or bipolar I disorder. The goal is to assess how well the drug is tolerated over 52 weeks. It is open to individuals aged 12 to 17 who have been diagnosed with either condition and are not currently using other experimental medications. Participants must be willing to complete all study aspects, with consent from a parent or guardian. As a Phase 4 trial, iloperidone has already received FDA approval and proven effective, and this research aims to understand how it benefits more patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, you cannot be on other investigational drugs when you join the trial.

What is the safety track record for iloperidone?

Research shows that iloperidone is generally well-tolerated, though some side effects may occur. Common side effects include trouble sleeping in about 18% of cases, anxiety in around 11%, and worsening of schizophrenia in about 9% of patients.

The FDA has approved iloperidone for treating schizophrenia in adults, indicating well-documented safety for this group. However, its safety and effectiveness in teenagers remain under study. While considered safe for adults, more research is needed to confirm its safety for younger individuals.

Later-phase clinical trials typically provide extensive safety information. Nonetheless, it is crucial to consider all potential risks and discuss them with a healthcare provider. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Iloperidone is unique because it targets dopamine and serotonin receptors in a way that may lead to fewer side effects compared to other antipsychotic medications used for adolescent schizophrenia, like aripiprazole or risperidone. Researchers are excited about this treatment as it offers a different chemical profile, potentially reducing the risk of weight gain and metabolic issues commonly associated with existing antipsychotics. Furthermore, iloperidone might improve adherence to treatment due to a more favorable side effect profile, which is crucial for managing schizophrenia in teenagers.

What is the effectiveness track record for iloperidone in treating adolescent schizophrenia?

Research has shown that iloperidone helps treat schizophrenia. In one study, patients taking iloperidone experienced better symptom improvement than those taking a placebo (a harmless pill with no real effect). Iloperidone worked as well as haloperidol, another treatment for schizophrenia, in preventing symptom recurrence. For bipolar I disorder, iloperidone is also considered safe and effective. Common side effects include trouble sleeping and anxiety. This trial examines the safety and tolerability of iloperidone for teenagers with schizophrenia over a 52-week period. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adolescents aged 12-17 with a clinical diagnosis of schizophrenia or bipolar I disorder. Participants must be willing to complete the study and have parental consent. Those using drugs of abuse or other investigational drugs recently cannot join.

Inclusion Criteria

Patient is willing and able to provide assent and willing to complete all aspects of the study

I am between 12 and 17 years old.

Patient's parent or legal guardian willing and able to provide consent

Exclusion Criteria

You cannot participate if you have taken any experimental drugs within the last 30 days or 5 half-lives before starting this study.

A positive test for drugs of abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive open-label iloperidone for up to 52 weeks

52 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 trial is testing the safety and how well patients can tolerate iloperidone, a medication intended for schizophrenia or bipolar I disorder in adolescents, over a period of up to one year.

How Is the Trial Designed?

Group I: Iloperidone Experimental Treatment 1 Intervention

Open-label iloperidone

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/PMC5167526/

Iloperidone in the treatment of schizophrenia: an evidence- ... All studies involved patients diagnosed with schizophrenia or related disorder or psychosis and were mainly conducted in USA (n=10), followed by ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05648591?term=ILOPERIDONE&rank=2

Safety and Tolerability of Open-Labeled Iloperidone in ... To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment. Official ...

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

Efficacy of iloperidone in schizophrenia: A PANSS five ... We conducted a 5-factor analysis for evaluating the efficacy of iloperidone vs. placebo across these different domains in the treatment of schizophrenia.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/18334910/

Long-term efficacy and safety of iloperidone: results from 3 ... Iloperidone was equivalent to haloperidol in time to relapse. The most common adverse events were insomnia (18.1%), anxiety (10.8%), and schizophrenia ...

5. mdedge.com mdedge.com/clinicalpsychiatrynews/article/267699/bipolar-disorder/schizophrenia-med-safe-effective-bipolar

Schizophrenia Med Safe, Effective for Bipolar Mania Iloperidone, a second-generation antipsychotic used to treat schizophrenia, appears to be safe and effective in the treatment of bipolar ...

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

FANAPT (iloperidone) tablets - accessdata.fda.gov Safety and effectiveness in pediatric and adolescent patients have not been established. 8.5 Geriatric Use. Clinical Studies of FANAPT in the treatment of ...

7. 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 or mixed episodes associated with bipolar disorder (manic-depressive illness).

8. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/385696

Safety and Tolerability of Open-Labeled Iloperidone in ... To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment. Fill ...