D1050326: Efficacy and Safety of Lurasidone in Bipolar I Depression
Research type
Research Study
Full title
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.
IRAS ID
168175
Contact name
Stephen Lawrie
Contact email
Sponsor organisation
Sunovion Pharmaceuticals Europe Ltd.
Eudract number
2013-004903-37
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 26 days
Research summary
The purpose of this research study is to evaluate the safety and effectiveness of a new drug (lurasidone) at different doses (20 mg/day to 80 mg/day), compared to a non-active drug (placebo) for use in children and adolescent subjects with bipolar I depression.
Adult bipolar disorder is a chronic and often disabling condition that affects approximately 4.4% of the population worldwide. The treatment of bipolar disorder is a challenging, in part due to its symptomatic complexity involving both relatively distinct, as well as, at times, overlapping manic and depressive phases (mania, mixed mania, and depression).
Approximately 14% to 28% of patients with bipolar disorder experience onset of illness before age 13 and that 50% to 67% experience onset before age 19. These children comprise a complex psychopathologic patient population who are characterised by poor functioning, high rates of hospitalisation, and elevated need for special education services
Lurasidone is a new compound being developed by Sunovion Pharmaceuticals Inc, and is an approved agent for the treatment of schizophrenia and bipolar depression. Lurasidone has been evaluated both as monotherapy and adjunctive therapy (to lithium or valproate) in two 6-week trials in adults with bipolar depression, and has received FDA approval for monotherapy and adjunctive treatment in this disorder. The pharmacologic profile and demonstrated efficacy and safety in adult patients with bipolar depression suggests that lurasidone, as monotherapy, may be an effective treatment in the paediatric bipolar depression population
About 340 adolescent children worldwide will take part in this research study for up to 7-9 weeks. Participants who complete this research study will be given the option to take part in a separate extension study.
REC name
Scotland A: Adults with Incapacity only
REC reference
15/SS/0005
Date of REC Opinion
18 Mar 2015
REC opinion
Further Information Favourable Opinion