EUCTR2004-000750-22-DE进行中（未招募）不适用
A 6-week, International, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Phase IIIb Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Immediate-release Tablets in Daily Doses of 400 mg and 800 mg Compared with Placebo in the Treatment of Adolescents with Schizophrenia - ANCHOR 112
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
- 198
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. Male or female, aged 13 to 17 years at randomization, hospitalized or outpatient
- •4. 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.
- •5. All female patients will need to have the absence of pregnancy confirmed by a
- •negative b-hCG before randomization
- •6. DSM-IV criteria for schizophrenia confirmed by the K-SADS-PL
- •7. The SCQ will be administered to assess for Pervasive Development Disorders.
- •Patients with an SCQ score of > or = 15 and who otherwise meet entrance criteria must have a documented history of delusions or hallucinations.
- •8. Patients with a secondary diagnosis of depression may continue treatment with an
- •antidepressant if clinically advised by the investigator, providing the antidepressant
- •is permitted by the protocol and the dose has been stable for > or = 30
- •days preceding randomization
- •9. PANSS score of > or = 60 and a score of 4 or greater on at least 1 of the following items;
- •delusions (P1), conceptual disorganizations (P2), or hallucinations (P3) at both
- •screening and randomization (Day 1)
- •10. Willingness to agree not to harm self
- •11. 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
- •12. 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) 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
排除标准
- •1. Secondary DSM-IV Axis I diagnoses of Bipolar Disorders including Cyclothymia,
- •Schizophreniform Disorder, Schizoaffective Disorder, Psychotic Disorder Not
- •Otherwise Specified (NOS), and acute (<3 months) Posttraumatic Stress Disorder
- •2. Premorbid intelligence quotient (IQ) <70 or diagnosis of mental retardation
- •3. 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.
- •4. Psychosis judged to be the direct physiological effect (eg, intoxication, withdrawal)
- •of an abused medication or substance
- •5. 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
- •6. Serious homicidal risk or homicidal behaviors within the past 3 months that resulted
- •in adjudication
- •7. Known intolerance for or lack of response to quetiapine, as judged by the
- •investigator
- •8. Contraindications as detailed in country-specific prescribing information for
- •9. For female patients, pregnancy or lactation
- •10. Substance abuse or dependence (Appendix D) including alcohol (except for caffeine
- •or nicotine dependence), as defined in DSM-IV, within 1 month prior to screening
- •11. Inability to discontinue psychoactive medications (see Section 3.4.4.1, Table 4)
- •prior to randomization
- •12. Use of haloperidol decanoate, fluphenazine decanoate or risperidone microspheres
- •within 1 dosing interval prior to randomization
- •13. Electroconvulsive therapy (ECT) within 30 days prior to screening
- •14. Use of potent cytochrome P450 (CYP) 3A4 inhibitors (eg, ketoconazole,
- •itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir,
- •nelfinavir, ritonavir, and saquinavir) in the 14 days preceding randomization
- •15. Use of potent CYP 3A4 inducers (eg, phenytoin, carbamazepine, barbiturates,
- •rifampin, glucocorticoids, Saint John’s Wort) in the 14 days preceding
- •randomization
- •16. Thyroid-stimulating hormone (TSH) concentration more than 10% above the upper limit of the normal range
- •17. Laboratory test results outside the reference range and considered by the
- •investigator to be clinically significant
- •18. Baseline QTc interval (Fridericia formula; Puddu et al 1988) > or = 450 milliseconds at 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 a baseline Glycosylated Hemoglobin
- •(HbA1c) Ÿ8.5
- •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 baseline
- •24. The physician responsible for the patient’s DM care has not approved the patient’s
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