To evaluate the safety and effectiveness of two different doses of lurasidone (40 mg/day and 80 mg/day) compared to a placebo for use in adolescent children with schizophrenia.
- Conditions
- SchizophreniaMedDRA version: 17.1Level: LLTClassification code 10001064Term: Acute schizophreniaSystem Organ Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2013-001695-38-BE
- Lead Sponsor
- SUNOVION PHARMACEUTICALS INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 309
Male or female subjects 13 to 17 years of age, inclusive, with DSM-IV-TR Axis I primary diagnosis of schizophrenia and confirmation of the schizophrenia diagnosis by means of the Schedule for Affective Disorders and Schizophrenia for School-age Children (K-SADS-PL). Positive and Negative Syndrome Scale (PANSS) total score = 70 at screening and Baseline; CGI-S = 4 at screening and Baseline.
Are the trial subjects under 18? yes
Number of subjects for this age range: 309
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
Has an Axis I or Axis II diagnosis other than schizophrenia that has been the primary focus of treatment within 3 months of screening.; Has a history or current diagnosis of mental retardation, neuroleptic malignant syndrome, or any neurologic disorder, severe head trauma, or any unstable medical condition. PANSS total scores = 120 at screening or Baseline.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method