Status:
COMPLETED
Tolerability and Pharmacokinetics of Iloperidone in Adolescent Patients
Lead Sponsor:
Vanda Pharmaceuticals
Conditions:
Safety and Tolerability of Iloperidone
Eligibility:
All Genders
12-17 years
Phase:
PHASE1
Brief 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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01495169
Start Date
October 1 2011
End Date
February 1 2015
Last Update
June 13 2016
Active Locations (10)
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1
Novartis Investigative Site
Costa Mesa, California, United States, 92626
2
Novartis Investigative Site
North Miami, Florida, United States, 33161
3
Novartis Investigative Site
Atlanta, Georgia, United States, 30308
4
Novartis Investigative Site
Coeur d'Alene, Idaho, United States, 83814