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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iloperidone | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iloperidone (oral tablet) | Drug | iloperidone 12 to 24 mg/day followed by 26 weeks of flexible dosing (6 to 24 mg/day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | Visit 5, 6, 7 (after at least 7 days of iloperidone treatment at the same dose level) |
| Tolerability of iloperidone at different dose levels | 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) | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients with Adverse Events, Serious Adverse Events or Death | Safety and tolerability profile in open-label extension | 26 weeks |
| Change from baseline in Clinical Global Impression of Improvement Scale (CGI-I) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Costa Mesa | California | 92626 | United States | ||
| Novartis Investigative Site |
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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."
| Baseline, then Weekly for 2 weeks, then every 2-4 weeks for 26 weeks |
| Change from baseline in the Children's Global Asessment Scale (CGAS | The CGAS) is a numeric scale (1 through 100) used to rate the general functioning of children; high scores indicate better functioning. | Baseline, then Weekly for 2 weeks, then every 2-4 weeks for 26 weeks |
| 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) | 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. | Baseline (24 hours), Visit 3 (4-hours post initial dose), and Visit 7 (13 hours |
| Clinically notable changes from baseline on electrocardiogram (ECG) parameters (QTcF, QTcB, QRS, PR, heart rate) | 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 | Screening, baseline, 5x over 2 weeks, then every 2-4 weeks for 26 weeks |
| North Miami |
| Florida |
| 33161 |
| United States |
| Novartis Investigative Site | Atlanta | Georgia | 30308 | United States |
| Novartis Investigative Site | Coeur d'Alene | Idaho | 83814 | United States |
| Novartis Investigative Site | Baltimore | Maryland | 21205 | United States |
| Novartis Investigative Site | St Louis | Missouri | 63044 | United States |
| Novartis Investigative Site | Marlton | New Jersey | 08053 | United States |
| Novartis Investigative Site | Cincinnati | Ohio | 45219 | United States |
| Novartis Investigative Site | Cleveland | Ohio | 44106-5000 | United States |
| Novartis Investigative Site | Salt Lake City | Utah | 84106 | United States |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
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| ID | Term |
|---|---|
| C081732 | iloperidone |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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