At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 350 enrolled
Drug / intervention
Lurasidone +1 moredrug
Likely dose
Lurasidone 80 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 Randomized, 6-Week, Double-blind, Placebo-Controlled, Flexible Dose, Parallel-Group Study to Evaluate the Efficacy and Safety of Lurasidone in Children and Adolescent Subjects With Bipolar I Depression
In Brief
A Phase 3 clinical trial evaluating Lurasidone and Placebo for Bipolar I Depression. Completed, enrolled 350 participants across 66 sites in 11 countries.
Detailed Summary
A study to evaluate efficacy and safety of flexibly dosed Lurasidone in children and adolescents with bipolar I depression
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar I Depression
CountriesBulgaria, Colombia, France, Hungary, Mexico, Philippines, Poland, Puerto Rico, South Korea, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 2014
Enrollment StartMar 2014
Primary CompletionOct 2016
TodayJul 2026
First PostedJan 27, 2014
Enrollment StartMar 1, 2014
Primary CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 12.4 years ago
Interventions
Lurasidonedrug
Lurasidone flexibly dosed 20-80 mg once daily
Placebodrug
Placebo Comparator once daily