EUCTR2004-000751-42-DE进行中（未招募）不适用
A 26-week, International, Multicenter, Open-label Phase IIIbStudy of the Safety and Tolerability of Quetiapine Fumarate (SEROQUEL™)Immediate-release Tablets in Daily Doses of 400 mg to 800 mg in Children andAdolescents with Bipolar I Disorder and Adolescents with Schizophrenia - ANCHOR 150
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Provision of written informed consent by one or both parents or by legal guardian
- •prior to any study procedure
- •2. Provision of written assent by the patient prior to any study procedure
- •3. Prior participation in Study D1441C00149 or Study D1441C00112 for > or = 14 days
- •4. Male or female; aged 13 to 17 years at randomization of Study D1441C00112 or
- •aged 10 to 17 years at baseline of Study D1441C00149. Patients who become
- •18 years of age after entering Study D1441C00112 or D1441C00149 will be
- •permitted to enter this OL study.
- •5. If female and of childbearing potential, must be using a reliable method of
- •contraception. Reliable methods may include abstinence, hormonal contraceptives
- •(eg, oral contraceptive or long-term injectable or implantable hormonal
- •contraceptive), double-barrier methods (eg, condom and diaphragm, condom and
- •foam, condom and sponge), intrauterine devices, and tubal ligation.
- •6. All female patients will need to have the absence of pregnancy confirmed by a
- •negative serum beta hCG before OL baseline
- •7. DSM-IV criteria for schizophrenia or bipolar I disorder, confirmed by the
- •K-SADS-PL at entry into the preceding double-blind Study D1441C00149 or Study
- •D1441C00112
- •8. Willingness to agree not to harm self
- •9. Have a parent or legal guardian who will accompany the patient at each scheduled
- •study visit, can provide reliable information, and can be responsible for receiving
- •and dispensing study medication
- •10. Willingness to adhere to the schedule of assessments
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years)
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. DSM-IV Axis I diagnoses of Schizophreniform Disorder, Schizoaffective Disorder,
- •Psychotic Disorder Not Otherwise Specified (NOS), Bipolar II Disorder, Bipolar
- •Disorder Not Otherwise Specified (NOS)
- •2. An interval greater than 7 days between the last double-blind study visit (OL
- •baseline) and Day 1
- •3. Premorbid intelligence quotient (IQ) <70 or diagnosis of mental retardation
- •4. Psychosis judged to be the direct physiological consequence of a medical condition
- •or treatment. These conditions include degenerative neurological conditions (eg,
- •Parkinson’s disease, Huntington’s disease), cerebrovascular disease (eg, stroke),
- •metabolic conditions (eg, vitamin B12 deficiency), autoimmune conditions (eg,
- •systemic lupus erythematosus), viral or other infections (eg, hepatitis,
- •mononucleosis, human immunodeficiency), and cancers.
- •5. Psychosis judged to be the direct physiological effect (eg, intoxication, withdrawal)
- •of an abused medication or substance
- •6. History of any serious suicide attempt that required medical intervention; or current
- •suicidal risk that cannot be safely managed as determined by the clinical judgment
- •of the investigator
- •7. Serious homicidal risk or homicidal behavior within the past 3 months that resulted
- •in adjudication
- •8. Known intolerance for or lack of response to quetiapine, as judged by the
- •investigator
- •9. Contraindications as detailed in country-specific prescribing information for
- •10. For female patients, pregnancy or lactation
- •11. Substance abuse or dependence including alcohol (except for caffeine or nicotine
- •dependence), as defined in DSM-IV, within 1 month prior to screening
- •12. Use of depot antipsychotics, eg, haloperidol decanoate, fluphenazine decanoate or risperidone microspheres, within 1 dosing interval of the start of open-label
- •13. Electronconvulsive therapy (ECT) within 30 days before enrollment
- •14. Use of potent cytochrome P450 (CYP) 3A4 inhibitors (eg, ketconazole,
- •itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir,
- •nelfinavir, ritonavir, and sequinavir) in the 14 days preceding enrollment
- •15. Use of potent CYP 3A4 inducers (eg, phenytoin, carbamazepine, barbiturates,
- •rifampin, glucocorticoids, Saint John’s Wort) in the 14 days preceding enrollment
- •16. Thyroid-stimulating hormone (TSH) concentration more than 10% above the upper limit of the normal range at OL baseline
- •17. Laboratory test results outside the reference range at OL baseline and considered by the investigator to be clinically significant
- •18. Baseline QTc interval (Fridericia formula; Puddu et al 1988) > or = 450 milliseconds at OL baseline
- •19. Renal, cardiovascular, hepatic, hematologic, endocrinologic, ophthalmologic, or
- •other disease or clinical finding that is unstable or that in the opinion of the
- •investigator would be negatively affected by study medication or that would affect
- •study medication
- •20. Unstable Diabetes Mellitus (DM) with an OL baseline HgbA1c > or = 8.5
- •21. Patients admitted to a hospital for treatment of diabetes or diabetes related illness in past 12 weeks
- •22. Not under the care of a physician responsible for the patient’s DM care
- •23. DM clinically unstable in the opinion of the physician responsible for the patient’s
- •diabetes management at the time of OL baseline
- •24. The physician responsible for the patient’s DM care has not approved the patient’s participation in the study
- •25. The patient has not been on the same dose of oral hypoglycemic drug(s) and/or diet f
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