Study Name: An 8-week, placebo-controlled, double-blind, randomized, fixed dose efficacy and safety trial of asenapine in adolescent subjects with schizophrenia
PI: Linmarie Sikich, MD
Sponsor: Schering-Plough Research Institute
Contact person: Lindsey Hazzard
Brief Description: The purpose of this research study is to examine the safety and efficacy of asenapine on improving functioning in adolescents with schizophrenia. This is a study in which participants will receive either placebo (fake medicine) or active asenapine for 2 months. There will be a total of 11 office visits: screening, baseline, day 1, day 4, week 1, week 2, week 3, week 4, week 6, week 8, and one other follow up visit after the study treatment has stopped. There will be phone calls throughout the study to check compliance and ability to manage self-administration of medication and to review adverse events. Please remember that all research studies involve potential risks for participants.
Subject Payment: Study medication and research related services will be free of charge, and participants will be compensated $50 per visit.
Major inclusion criteria:
- Between the ages of 12 and 17, male or female, any race or ethnicity
- Clinical diagnosis of schizophrenia of paranoid, disorganized, or undifferentiated subtype
Major exclusion criteria:
- Must not have an uncontrolled, unstable clinically significant medical condition that may interfere with the interpretation of safety and efficacy evaluations
- Subjects must not have uncontrolled or unstable diabetes or a clinically significant abnormal blood glucose level
- Pregnancy/Nursing because of the unknown effects of asenapine to unborn babies and/or nursing infants. Female participants must not have the intention to become pregnant while receiving protocol-specified medication and for at least one month after stopping the medication All females of child-bearing potential will be administered a urine or serum pregnancy test at screening and at any point during the study at physician discretion. Refusal to undergo a pregnancy test will result in exclusion from the study. We will share results of pregnancy test with the subject’s legal guardian.
- ·Refusal to practice contraception if sexually active because the effects of exposure to high concentrations of asenapine on sperm or newly conceived embryos are unknown. Sexually active men and women should not take part in this study if they and their partners are not both using an effective birth control method (for example, women use birth control pills, an intrauterine device [IUD] or a diaphragm and men use condoms).
- Subjects must not have any known or suspected (non-febrile) seizure disorder
- Subjects must not have a known serological evidence of human immunodeficiency virus (HIV) antibody
- Subjects must not have a history of neuroleptic malignant syndrome
- Subjects must not have a history of tardive dyskinesia or tardive dystonia
- Subjects must not have a diagnosis of schizoaffective disorder; schizophrenia of residual subtype; schizophrenia of catatonic subtype, or schizophrenia with “continuous,” “single episode in partial remission,” or “single episode in full remission” course specifier
- Subjects must not have a primary Axis I diagnosis other than schizophrenia and must not have a comorbid Axis I diagnosis that is primarily responsible for current symptoms and functional impairment
- Subjects must not have a known or suspected diagnosis of mental retardation or organic brain disorder
- Subjects must not have a positive urine drug/alcohol screen finding at the Screening visit, unless the positive finding can be accounted for by documented prescription use. Subjects with positive alcohol, cannabis, or other psychotropic medication results may be included at the investigator's discretion
- Subjects must not currently (within the past 6 months) meet the DSM-IV-TR criteria for substance abuse or dependence (excluding nicotine)
- Subjects must not have a diagnosis of psychotic disorder or a behavioral disturbance thought to be substance induced or due to substance abuse
- Subject must not be at imminent risk of self-harm or harm to others, in the investigator’s opinion based on clinical interview and responses provided on the C-SSRS. Subjects must be excluded if they report suicidal ideation in the past 2 months or suicidal behavior in the past 6 months
- Subjects must not currently be under involuntary inpatient
- Subjects must not be unwilling to discontinue or, in the opinion of the investigator, unable to safely taper off any prohibited treatment prior to the baseline visit without significant destabilization or increased suicidality
Target enrollment: 4
Date enrollment closes: TBD