D1050301: Efficacy and Safety of Lurasidone in Schizophrenia
Research type
Research Study
Full title
A 6-Week Randomized, Parallel, Double-Blind, Placebo-Controlled, Fixed-Dose, Multicenter Study to Evaluate The Efficacy and Safety of Lurasidone in Adolescent Subjects with Schizophrenia.
IRAS ID
164173
Contact name
Stephen Lawrie
Contact email
Sponsor organisation
Sunovion Pharmaceuticals Europe Ltd.
Eudract number
2013-001695-38
Duration of Study in the UK
0 years, 11 months, 28 days
Research summary
This is a randomised, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of 2 fixed doses of lurasidone (40 mg and 80 mg/day) for 6 weeks compared with placebo in adolescent subjects with acute schizophrenia.
Schizophrenia is a severe and debilitating mental illness that affects approximately 1% of the population worldwide. Schizophrenia is characterised by acute psychotic episodes and chronic lasting symptoms. Patients with schizophrenia typically have long-term and profound psychosocial impairments.
While the onset of schizophrenia typically occurs in young adulthood (ages 18-25), adolescent onset is not uncommon in individuals aged 13 to 18 years old. The initial presentation of schizophrenia in adolescence differs somewhat from adult onset, including a typically more gradual onset, more severe premorbid neurodevelopmental abnormalities, and the presence of more frequent visual hallucinations. Despite some differences in initial presentation, the overall goal of treatment in adolescent patients with schizophrenia remains identical to that of adult onset schizophrenia: to improve the severity of positive and negative symptoms and improve the overall function of the patient.
Lurasidone is a new compound being developed by Sunovion Pharmaceuticals Inc, and is an approved agent for the treatment of adult patients with schizophrenia. Clinical studies in adults with schizophrenia treated with lurasidone have shown significant beneficial effects on the improvement of positive and negative symptoms with a minimal effect on weight gain, glucose metabolism, and lipid parameters. Based on its pharmacological profile and observed safety and efficacy in adult patients with schizophrenia, lurasidone has the potential to be a safe and effective treatment for schizophrenia in the adolescent population (13-17 year olds).
About 309 adolescent children worldwide will take part in this research study for up to 10 weeks. Participants who complete this research study will be given the option to take part in a separate extension study.
REC name
Scotland A REC
REC reference
14/SS/1060
Date of REC Opinion
8 Dec 2014
REC opinion
Further Information Favourable Opinion