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Completed

NCT Number: NCT01495169

Tolerability and Pharmacokinetics of Iloperidone in Adolescent Patients

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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Key information

Conditions

Safety and Tolerability of Iloperidone Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Costa Mesa, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

iloperidone (oral tablet)

Drug

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

Primary outcomes

  1. Pharmacokinetics of iloperidone at different dose levels based on AUC (area under the plasma concentration time curve during a dosage interval) Cmax ss (maximum plasma concentration at steady state), Tmax ss (time to Cmax at steady state).

    Time frame: Visit 5, 6, 7 (after at least 7 days of iloperidone treatment at the same dose level)

    Pharmacokinetics describes the action of a drug in the body over a period of time. Blood samples are collected to measure plasma concentrations of the study drug at different times after dosing. From the plasma concentration data, AUC, Cmax ss, and Tmax ss are calculated.

  2. Tolerability of iloperidone at different dose levels

    Time frame: 14 days

    Frequency of treatment emergent adverse events, frequency of clinically notable changes from baseline in vital signs, electrocardiograms, laboratory tests, and reponses on movement disorder rating scales (Barnes Akathisia Rating Scale, Simpson-Angus Scale) and on a rating scale for suicidal thoughts and behaviors (Columbia Suicide Severity Rating Scale)

Secondary outcomes

  1. Number of Patients with Adverse Events, Serious Adverse Events or Death

    Time frame: 26 weeks

    Safety and tolerability profile in open-label extension

  2. Change from baseline in Clinical Global Impression of Improvement Scale (CGI-I)

    Time frame: Baseline, then Weekly for 2 weeks, then every 2-4 weeks for 26 weeks

    The CGI-I is scored from 1 to 7 and assesses the overall degree of illness relative to baseline. A CGI-I rating of 4 is equivalent to "no change." Ratings less than 4 are equivalent to "improvement" and ratings of more than 4 are equivalent to "worsening."

  3. Change from baseline in the Children's Global Asessment Scale (CGAS

    Time frame: Baseline, then Weekly for 2 weeks, then every 2-4 weeks for 26 weeks

    The CGAS) is a numeric scale (1 through 100) used to rate the general functioning of children; high scores indicate better functioning.

  4. Effect of iloperidone on QT, QT beat-to-beat (QTbtb), QT corrected using the Fridericia formulat (QTcF), QT corrected using the Bazett formula (QTcB), individual based correct QT (QTcI)

    Time frame: Baseline (24 hours), Visit 3 (4-hours post initial dose), and Visit 7 (13 hours

    Patients wear a holter monitor for ~24 hours during the baseline period, for an additional 4 hours after the first dose, and for ~13 hours after they have been on the same dose for at least 7 days to compare how the heart beats before and after the study drug is taken. The holter monitor transmits continuous data to a computer on how the heart beats for the time when the monitor is on and is a better measurement than data collected by a traditional electrocardiogram (ECG), which provides data on a limited number of heart beats over a short period of time.

  5. Clinically notable changes from baseline on electrocardiogram (ECG) parameters (QTcF, QTcB, QRS, PR, heart rate)

    Time frame: Screening, baseline, 5x over 2 weeks, then every 2-4 weeks for 26 weeks

    Three ECGs are obtained for each assessment. The values are averaged for each ECG parameter (QTcF, QTcB, QRS, PR interval, heart rateare) and clinically notable changes from baseline and new or worsening heart rhythm disorders are identified

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study title

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)

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Dec 19, 2011
Registry last updated
Jun 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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