Tolerability and Pharmacokinetics of Iloperidone in Adolescent Patients

A Multicenter, Open-label, Sequential Cohort, Dose-escalation, 14-day Study to Explore the Tolerability and Pharmacokinetics of Iloperidone 12 to 24 mg/Day Followed by 26 Weeks of Flexible Dosing (6 to 24 mg/Day) in Adolescent Patients (Aged 12 to 17 Years)

Tolerability, undertstanding of the action of the drug in the body, and understanding the effect of the drug in adolescent patients needing treatment with an antipsychotic medication

Inclusion Criteria:

• males or females 12-17 years of age.
• in a stable housing situation with a guardian/parent who can encourage compliance with the study protocol.
• with diagnosis of disorder requiring treatment with an antipsychotic agent.
• having a Children's Global Assessment of Severity Scale (CGAS) of 41 or greater.
• Heart rate </=100 beats per minute and >/= 50 beats per minute.

Exclusion Criteria:

• Patients with mild, moderate or severe mental retardation (i.e., documented IQ <70), do not have the capacity to assent, cannot understand the informed consent, or participate fully in the assessments.
• Hospitalized due to suicidal ideation or suicidal behavior, history of suicidal ideation within 6 months prior to screening, history of suicidal behavior within 2 years prior to screening.
• Pregnant, females who can become pregnant and lactating females.
• Known hypersensitivity to iloperidone and to related drugs.
• Clinical conditions (Neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal or urological), which may pose significant risk to patients or impair reliable study participation.
• Clinically unstable cardiac disease, structural cardiac abnormalities, congential long QT syndrome, clinically significant ECG abnormalities at screening (PR interval >240 ms, QTcF >450 ms, QRS duration >/= 100 ms) or arrhythmias.
• Syncope, near syncope, or palpitations. Other protocol-defined inclusion/exclusion criteria may apply.