An 8-week, placebo-controlled, double-blind, randomized, fixed-dose efficacy and safety trial of asenapine in adolescent subjects with schizophrenia - Gemini-S8
- Conditions
- SchizophreniaMedDRA version: 12.1 Level: LLT Classification code 10039626 Term: Schizophrenia
- Registration Number
- EUCTR2009-017971-10-RO
- Lead Sponsor
- Schering-Plough Research Institute, a Division of Schering Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 306
The subject must fulfill ALL the criteria listed below for entry.
1. Each subject’s parent(s) or legal representative must be willing and able to provide written informed consent for the trial and each subject must indicate assent.
Each subject’s parent(s) or legal representative must provide separate written informed consent for pharmacogentic testing and each subject must indicate assent.
Subjects whose parent(s) or legal representative are unwilling to provide written informed consent for pharmacogenetic testing, or who do not assent to pharmacogenetic testing, may be included in the trial; however, pharmacogenetic samples must not be obtained.
2. Each subject must be =12 years of age when indicating assent to participate in the trial up to <18 years of age when randomly assigned to treatment. A subject may be of either sex, and of any race/ethnicity.
3. Each subject must have a current diagnosis of schizophrenia of paranoid (295.30), disorganized (295.10), or undifferentiated (295.90) subtype, which is confirmed by the K-SADS-PL;
4. Each subject must have a minimum PANSS total score of 80 at Screening and Baseline;
5. Each subject must have a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4 (moderately ill) at Screening and Baseline;
6. Each subject must have a score of at least 4 (moderate) on two or more of the five items in the positive subscale of the PANSS (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/persecution) at Screening and Baseline;
7. Each subject must be a male, or a female who is not of childbearing potential (e.g., surgically sterile) or who is non-pregnant, non-lactating, and is not sexually active or is using a medically accepted method of contraception.
Acceptable methods of contraception include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device (IUD), and hormonal contraceptives.
A female subject of child-bearing potential who is not currently sexually active must agree to use a medically accepted method of contraception while receiving protocol specified medication and for 1 month after stopping the medication should she become sexually active while participating in the trial.
8. Each subject must be fluent in the language of the investigator, trial staff (including raters), and the informed consent.
9. Each subject must have a caregiver who is considered reliable by the investigator and who has agreed to provide support to the subject to ensure compliance with trial treatment, outpatient visits, and protocol procedures. The caregiver must be living with the subject and can be the subject’s parent(s) or legal representative.
10. Each subject must have tapered off all prohibited psychotropic medications (including antipsychotics, antidepressants, and mood stabilizers; see section 7.4.2.1 of the protocol) prior to baseline (the dosing cycle of depot neuroleptics must end prior to Baseline).
11. Each subject must agree not to begin formal, structured psychotherapy during treatment during the trial.
Are the trial subjects under 18? yes
Number of subjects for this age ran
The subject must fulfill ALL the criteria listed below for entry.
1. A subject must not have an uncontrolled, unstable clinically significant medical condition (e.g., renal, endocrine, hepatic, respiratory, cardiovascular, hematologic, immunologic or cerebrovascular disease, or malignancy) that may interfere with the interpretation of safety and efficacy evaluations in the opinion of the investigator.
2. A subject must not have a clinically significant abnormal laboratory, vital sign, physical examination, or ECG finding at Screening that, in the investigator’s opinion, precludes the subject’s participation in the trial (potentially interferes with the ability to evaluate safety, tolerability and efficacy of trial medication or potentially impairs the subject’s ability to complete the trial).
3. A female subject must not have a positive serum pregnancy test at Screening, and must not have the intention to become pregnant while receiving protocol-specified medication and for at least one month after stopping the medication.
4. A female subject must not be breast-feeding.
5. A subject must not have uncontrolled or unstable diabetes or a clinically significant abnormal blood glucose level at Screening and Baseline.
6. A subject must not have any known or suspected (non-febrile) seizure disorder.
7. A subject must not have known serological evidence of human immunodeficiency virus (HIV) antibody.
8. A subject must not have a history of neuroleptic malignant syndrome.
9. A subject must not have a history of tardive dyskinesia or tardive dystonia;
10. A subject must not have a diagnosis of schizoaffective disorder (295.70); schizophrenia of residual subtype (295.60); schizophrenia of catatonic subtype (295.20), or schizophrenia with continuous,” single episode in partial remission,” or single episode in full remission” course specifier.
11. A subject 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.
12. A subject must not have a known or suspected diagnosis of mental retardation or organic brain disorder.
13. A subject 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 following the guidelines of Section 7.6.1 of the protocol, procedure on urine alcohol/drug screen.
14. A subject must not currently (within the past 6 months) meet the DSM-IV-TR criteria for substance abuse or dependence (excluding nicotine).
15. A subject must not have a diagnosis of psychotic disorder or a behavioral disturbance thought to be substance induced or due to substance abuse.
16. A 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. Note that subjects must be excluded if they report suicidal ideation of Type 4 or 5 in the past 2 months or suicidal behavior in the past 6 months as measured by the C-SSRS at
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate clinically and statistically significant superiority of at least one asenapine dose to placebo in adolescents diagnosed with schizophrenia, as measured by the Positive and Negative Syndrome Scale (PANSS) total score at Day 56.;<br> Secondary Objective: Key Secondary Efficacy Trial Objectives:<br> To evaluate the efficacy of asenapine compared with placebo with respect to:<br> • Change from Baseline in the Clinical Global Impression of Severity of subjects’ illness (CGI-S) at Day 56<br> • The proportion of total PANSS 30% responders (modified definition) at Day 56/endpoint.<br> For other secondary trial objectives see section 6.3 of the protocol.<br> ;Primary end point(s): The change from baseline in PANSS total score at Day 56.
- Secondary Outcome Measures
Name Time Method