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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

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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%
Cramping
8%
Palpitations
8%
Increased Irritability
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Iloperidone

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
61 Previous Clinical Trials
19,304 Total Patients Enrolled
5 Trials studying Schizophrenia
1,370 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial involve any geriatric participants?

"According to the requirements stipulated in this trial's application process, minors aged 12 and above but younger than 17 are eligible for enrollment."

Answered by AI

Does my profile meet the requirements for participating in this experiment?

"In order to be accepted into this clinical trial, participants must have a diagnosis of schizophrenia and range in age from 12 to 17. 100 individuals will eventually join the study."

Answered by AI

Has recruitment for this trial opened yet?

"According to the details published on clinicaltrials.gov, this medical research project is actively seeking participants. The trial has been exhibited since December 1st 2022 and was last edited five days ago."

Answered by AI

Can Iloperidone be utilized without risk of adverse effects?

"Iloperidone has met the criteria for Phase 4 trials, indicating that it is approved and ready to be used therapeutically. Therefore, our team at Power gave this medication a safety rating of 3."

Answered by AI

What is the maximum capacity for enrolment in this medical trial?

"Affirmative. The details of the clinical trial, which was first introduced on December 1st 2022, are readily available via clinicaltrials.gov and show that recruitment is still underway. 100 test subjects will be selected from a single medical centre for this experiment."

Answered by AI

Who else is applying?

What site did they apply to?
Vanda Investigational Site
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

I need some help. I am interested in in making money. I’ve tried all natural supplements but non of them work for my conditions.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Safety and Tolerability of Open-Labeled Iloperidone in Adolescents
2023. "Safety and Tolerability of Open-Labeled Iloperidone in Adolescents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05648591.
All > Schizophrenia
~27 spots leftby Sep 2024
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