Tolerability and Pharmacokinetics of Iloperidone in Adolescent Patients

Completed · Phase 1

Conditions studied: Safety and Tolerability of Iloperidone

In brief

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

Key facts

Study ID

NCT01495169

Run by

Vanda Pharmaceuticals

People needed

33

Starts

2011-10-01

Expected to finish

2015-02-01

Last updated by the study team

2016-06-13

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — Costa Mesa, California, United States
• Novartis Investigative Site — North Miami, Florida, United States
• Novartis Investigative Site — Atlanta, Georgia, United States
• Novartis Investigative Site — Coeur d'Alene, Idaho, United States
• Novartis Investigative Site — Baltimore, Maryland, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Marlton, New Jersey, United States
• Novartis Investigative Site — Cincinnati, Ohio, United States
• Novartis Investigative Site — Cleveland, Ohio, United States
• Novartis Investigative Site — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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