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Atypical Antipsychotic

Iloperidone Safety for Adolescent Schizophrenia

Verified Trial
Phase 4
Recruiting
Research Sponsored by Vanda Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female patients 12 through 17 years of age (inclusive)
Clinical diagnosis of either schizophrenia or bipolar I disorder
Timeline
Screening 3 days
Treatment Varies
Follow Up 3 days
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial tested a drug to help teens with schizophrenia/bipolar for up to a year, to see if it is safe and tolerable.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not explicitly listed here, common side effects of iloperidone may include dizziness, dry mouth, fatigue, nasal congestion, and potential changes in heart rhythm or weight.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 12 and 17 years old.
Select...
I have been diagnosed with schizophrenia or bipolar I disorder.

Timeline

Screening ~ 3 days
Treatment ~ Varies
Follow Up ~3 days
This trial's timeline: 3 days for screening, Varies for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period.

Side effects data

From 2014 Phase 4 trial • 20 Patients • NCT01464229
46%
Dry Mouth
15%
Nausea
15%
Somnolence
15%
Headaches
8%
Palpitations
8%
Cramping
8%
Increased Irritability
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Iloperidone

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: IloperidoneExperimental Treatment1 Intervention
Open-label iloperidone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Iloperidone
2015
Completed Phase 4
~1560

Find a Location

Who is running the clinical trial?

Vanda PharmaceuticalsLead Sponsor
62 Previous Clinical Trials
19,330 Total Patients Enrolled
6 Trials studying Schizophrenia
1,394 Patients Enrolled for Schizophrenia

Media Library

Iloperidone (Atypical Antipsychotic) Clinical Trial Eligibility Overview. Trial Name: NCT05648591 — Phase 4
Schizophrenia Research Study Groups: Iloperidone
Schizophrenia Clinical Trial 2023: Iloperidone Highlights & Side Effects. Trial Name: NCT05648591 — Phase 4
Iloperidone (Atypical Antipsychotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05648591 — Phase 4
~41 spots leftby Nov 2025
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