Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT01620060
Brief Summary:
This is a Phase 1, open-label, multicenter, single and multiple ascending lurasidone dose study in subjects from 6 to 17 years old with schizophrenia spectrum, bipolar spectrum, autistic spectrum disorder, or other psychiatric disorders.
Detailed Description:
To characterize lurasidone PK profile following single and multiple oral doses of 20, 40,80, 120 or 160 mg/day lurasidone in the targeted pediatric/adolescent population (6-17 years old)with schizophrenia spectrum, bipolar spectrum, autistic spectrum disorder or other psychiatric disorders. Data from this study will be used to recommend pediatric doses that result in comparable exposures to those observed in currently approved adult doses of Latuda® (40, 80, 120 and 160 mg/day) in subsequent efficacy and safety studies.
Study:
NCT01620060
Study Brief:
Protocol Section:
NCT01620060