A 6-Week Study to Evaluate the Efficacy and Safety of Lurasidone in Children and Adolescent Subjects with Bipolar I Depressio

• Conditions: bipolar I disorder; MedDRA version: 17.0Level: PTClassification code 10004939Term: Bipolar I disorderSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-004903-37-Outside-EU/EEA
• Lead Sponsor: Sunovion Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-30
• Last Update Posted: 12 May 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

Male or female subjects 10 to 17 years of age, inclusive with bipolar I disorder, most recent episode depressed with or without rapid cycling disease course and without psychotic features. Children's Depression Rating Scale, Revised (CDRS-R) total score = 45 at screening and Baseline. Young Mania Rating Scale (YMRS) score = 15 (with YMRS Item 1 [elevated mood] score = 2) at screening and Baseline.
Are the trial subjects under 18? yes
Number of subjects for this age range: 340
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Has an Axis I or Axis II diagnosis other than bipolar I disorder that has been the primary focus of treatment within 3 months of screening. Has a history or current diagnosis of intellectual disability, Autism Spectrum Disorder, neuroleptic malignant syndrome, or any neurologic disorder, severe head trauma, or any unstable medical condition. CDRS-R total score > 85 at screening or Baseline

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified