Tolerability and Pharmacokinetics of Iloperidone in Adolescent Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-02-28

Brief Summary

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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

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Detailed Description

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Conditions

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Safety and Tolerability of Iloperidone

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Iloperidone

Part A (dose-escalation and fixed dose): Eligible patients receive iloperidone 2mg/day (1 mg BID) on day 1, then escalated every day for up to 12days utilizing a forced titration regimen to achieve a maximum dose of 12, 16, 20 or 24 mg/day given BID. Part B (optional extension phase): Patients who successfully complete Part A of the study are eligible to continue treatment with iloperidone for an additional 26 weeks

Group Type EXPERIMENTAL

iloperidone (oral tablet)

Intervention Type DRUG

iloperidone 12 to 24 mg/day followed by 26 weeks of flexible dosing (6 to 24 mg/day)

Interventions

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iloperidone (oral tablet)

iloperidone 12 to 24 mg/day followed by 26 weeks of flexible dosing (6 to 24 mg/day)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No