Tolerability and Pharmacokinetics of Iloperidone in Adolescent Patients

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanda Pharmaceuticals
• Treatments: Iloperidone

Criteria

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/= 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.