The purpose of this research study is to evaluate the safety and effectiveness of lurasidone (20 mg/day to 80 mg/day) compared to a placebo for use in children and adolescent subjects with bipolar I depression.

Phase 1

• Conditions: Bipolar I depression; MedDRA version: 17.1Level: LLTClassification code 10004936Term: Bipolar depressionSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2013-004903-37-DE
• Lead Sponsor: SUNOVION PHARMACEUTICALS INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-29
• Last Update Posted: 2 October 2017

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 (= 4 episodes of mood disturbance but < 8 episodes in the previous 12 months) and without psychotic features (diagnosed by DSM-V criteria, and confirmation of the bipolar I disorder diagnosis by an adequately trained clinician at the time of screening, by means of the Schedule for Affective Disorders and Schizophrenia for School-age Children [K-SADS-PL]). 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 and/or concomitant ADHD 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