Safety and Tolerability of Open-Labeled Iloperidone in Adolescents
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age12-17
SponsorVanda Pharmaceuticals
About this trial
To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient is willing and able to provide assent and willing to complete all aspects of the study
Patient's parent or legal guardian willing and able to provide consent
Male or female patients 12 through 17 years of age (inclusive)
Clinical diagnosis of either schizophrenia or bipolar I disorder
Disqualifiers
Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
A positive test for drugs of abuse
Trial design
Design model
Single group
Treatments tested in this trial
Iloperidone
Drugoral tablet
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: IloperidoneExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov