Efficacy and safety of asenapine treatment for pediatric bipolar disorder
- Conditions
- Acute Manic or Mixed Episodes Associated with Bipolar I DisorderMedDRA version: 14.0Level: LLTClassification code 10068455Term: Bipolar I disorder, hypomanicSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2010-022647-38-Outside-EU/EEA
- Lead Sponsor
- Schering-Plough Research Institute, a Division of Schering Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 400
1. Each subject’s parent(s) or legal representative must be willing and able to provide written informed consent for the trial. Each subject must indicate assent/consent before study participation.
Each subject’s parent(s) or legal representative must provide separate written informed consent for pharmacogentic testing and each subject must indicate assent/consent.
2. Each subject must be =12 years of age when indicating assent/consent to participate in the trial and =17 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 diagnosis of primary bipolar I disorder, current episode manic (296.4x), or mixed (296.6x) with or without psychotic features as confirmed by a structured clinical interview (K-SADS-PL) at screening.;
4. Each subject must have a YMRS total score = 20 at Screening and Baseline;
Each subject must have a severity of bipolar illness = 4 as measured on the CGI-BPoverall at Screening and Baseline;
6. Each subject must be a male, or a female who is not of childbearing potential (eg, surgically sterile) or who is non-pregnant, non-lactating, and is using a medically accepted method of contraception. If a female subject of childbearing potential, must agree to use a medically
accepted method of contraception while receiving protocol specified medication and for 1 month after stopping the medication.
7. Each subject must understand the nature of the study;
8. Each subject must have tapered off all prohibited psychotropic medications prior to Baseline;
9. Each subject must be fluent in the language of the investigator, trial staff (including raters), and the informed consent;
10. Each subject must have a caregiver, or an identified responsible person, living with the subject, 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;
Refer to protocol for complete list
Are the trial subjects under 18? yes
Number of subjects for this age range:
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
1. The subject has a diagnosis of bipolar II disorder, bipolar disorder not otherwise specified, a pervasive developmental disorder, schizophrenia, schizoaffective disorder, post traumatic stress disorder (PTSD), or obsessive compulsive disorder (OCD);
2. The subject has a primary Axis I diagnosis other than bipolar I disorder and has a comorbid Axis I diagnosis that is primarily responsible for current symptoms and functional impairment;
3. The subject has a diagnosis of psychotic disorder or psychosis due to another medical condition or concomitant medication;
4. The subject has a known or suspected diagnosis of mental retardation, organic brain disorder, or an IQ <70;
5. The subject meets the DSM IV TR™ criteria for substance abuse or dependence (excluding nicotine and caffeine) within the past 6 months;
6. The subject has a diagnosis of psychotic disorder or a behavioral disturbance thought to be substance induced or due to substance abuse;
7. The subject is at imminent risk of self-harm or harm to others, in the investigator’s opinion based on clinical interview or on responses provided on the C-SSRS. Subjects must be excluded at Screening if they report suicidal ideation of Type 4 or 5 (ie, suicidal ideation with intent, with or without a plan) in the past 2 months or suicidal behavior in the past 6 months as measured by the C-SSRS; subjects must be excluded at Baseline if they report suicidal ideation of Type 4 or
5 or suicidal behavior between Screening and Baseline as measured by the C-SSRS;
8. The subject has a history of tardive dyskinesia or tardive dystonia;
9. The subject has or had catatonic features;
10. The subject has uncontrolled or unstable diabetes or had a clinically significant abnormal blood glucose level at Screening that was confirmed by repeat testing;
11. The subject has an uncontrolled or unstable clinically significant medical condition (eg, renal, endocrine, respiratory, cardiovascular, hematological, immunologic, neurological or cerebrovascular disease, malignancy, or eating disorder) that may interfere with the interpretation of safety and efficacy evaluations in the opinion of the investigator;
12. The subject has clinically significant abnormal laboratory, vital sign, physical examination, or ECG findings at Screening that, in the investigator’s opinion, preclude the subject’s participation in the trial;
13. A subject has laboratory and/or clinical evidence of clinically significant hepatic conditions, such as:
• ALT or AST >3 x ULN and total bilirubin >2 x ULN; or
• ALT or AST >3 x ULN with the appearance of jaundice, worsening of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia;
14. The subject is a female who is pregnant or breast-feeding;
15. The subject is a female with a positive pregnancy test at Screening, or with the intention to become pregnant during the course of the trial including the follow-up;
16. The subject has any known or suspected (non-febrile) seizure disorder;
17. The subject has known serological evidence of human immunodeficiency virus (HIV) antibody;
18. The subject has a history of neuroleptic malignant syndrome;
19. The subject has a positive drug/alcohol screen at the screening visit. (Subjects with positive psychotropic medication results may be included provided the finding can be accounted for by documented prescription use and the subject is able and willing t
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