At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 105 enrolled
Drug / intervention
Lurasidonedrug
Likely dose
Lurasidone 160 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1 Open-Label, Multicenter, Single and Multiple Ascending Dose Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Lurasidone in Subjects 6 to 17 Years Old With Schizophrenia Spectrum, Bipolar Spectrum, Autistic Spectrum Disorder, or Other Psychiatric Disorders
In Brief
A Phase 1 clinical trial evaluating Lurasidone for Schizophrenia and Autism. Completed, enrolled 105 participants across 10 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Autism
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2012
First PostedJun 2012
Primary CompletionMay 2013
TodayJul 2026
First PostedJun 15, 2012
Enrollment StartJun 1, 2012
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 14.0 years ago
Interventions
Lurasidonedrug
Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days