EUCTR2009-010276-16-DE进行中（未招募）不适用
A Long-Term, Open-Label, Safety Study of Oral Olanzapine in Adolescents with Bipolar I Disorder (Manic or Mixed Episodes) or Schizophrenia - HGMX
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Eli Lilly
- 入组人数
- 285
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
- •Patients are eligible for inclusion in this study only if they meet all of the following
- •[1] Have a diagnosis of bipolar I disorder and display an acute manic or mixed episode (with or without psychotic features) according to the DSM-IV-TR and confirmed by the K-SADS-PL, including the following diagnoses: 296.4x Bipolar I Disorder, Most Recent Episode Manic and 296.6x Bipolar I Disorder, Most Recent Episode Mixed.
- •Have a diagnosis of schizophrenia (295.10, 295.20, 295.30, 295.60, and 295.90) according to the DSM-IV-TR and confirmed by the K-SADS-PL Patients must meet diagnostic criteria at Visits 1 and 2.
- •[2] Meet severity criteria as follows:
- •Patients with a diagnosis of schizophrenia must obtain a BPRS-C total score >30, with a minimum score of 3 on at least one of the following items at both Visits 1 and 2:
- •hallucinations
- •delusions
- •peculiar fantasies.
- •Patients with a diagnosis of bipolar I disorder must have a YMRS total score =15 at both Visits 1 and 2.
- •[3] All females must test negative for pregnancy and must agree to abstain and/or be using a medically accepted means of contraception during the study.
- •[4] Has given assent (when applicable); and has a parent or authorized legal representative who has given informed consent, is reliable, has a level of understanding sufficient to permit patient to perform all tests and examinations required by the protocol, and understands the nature of the study.
- •[5] Are male or female patients, 13 to 17 years of age, who will not reach their 18th birthday before Visit 1, when informed consent is obtained.
- •[6] Are capable of swallowing study medication whole (without crushing, dissolving, etc.).
- •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
- •Patients will be excluded from the study if they meet any of the following criteria:
- •[7] Have a history of mental retardation, current comorbid autism, or current comorbid Pervasive Developmental Disorder.
- •[8] Have DSM-IV-TR substance (except nicotine and caffeine) dependence within the past 30 days prior to Visit 2.
- •[9] Have been judged clinically to be at any suicidal risk.
- •[10] Have undergone treatment with remoxipride within 6 months (180 days) prior to Visit 2.
- •[11] Have a history of allergic reaction or hypersensitivity to olanzapine.
- •[12] Are receiving current pharmaceutical treatment for weight management or are participating in a structured behavioral diet and/or exercise weight loss program.
- •[13] Other antipsychotics, mood stabilizers, or anticonvulsants used for the primary study conditions are excluded. Patients on these medications must have them discontinued 2 days prior to Visit 2.
- •[14] Have acute, serious, or unstable medical conditions, including (but not
- •limited to):
- •inadequately controlled diabetes (hemoglobin A1c [HgbA1c] >8%)
- •severe hypertriglyceridemia (fasting triglycerides =500 mg/dL [=5.65 mmol/L])
- •inadequately controlled thyroid disease (Patients needing a thyroid hormone supplement to treat hypothyroidism must have been on a stable dose of the medication for at least 2 months (60 days) prior to Visit 2.)
- •known uncorrected narrow-angle glaucoma
- •hepatic insufficiency (specifically any degree of jaundice)
- •cerebrovascular accidents
- •serious acute systemic infection or immunologic disease (including Human Immunodeficiency Virus positive status)
- •unstable cardiovascular disorders (including ischemic heart disease)
- •any other major renal, gastroenterologic, respiratory, endocrinologic, neurologic, or hematologic diseases (including current absolute neutrophil count <1,500 mm3 [1.5 GI/L, or 1.5 10E3/uL])
- •[15] Have any illness such that death is anticipated within 1 year or intensive care unit hospitalization for the illness is anticipated within 12 months (365 days).
- •[16] Have had one or more seizures without a clear and resolved etiology. However, if the patient has had one or more seizures in the past with an identifiable etiology and that etiology has been resolved, the patient may be entered. Note: the site must contact the sponsor or its representatives prior to entering a patient who has experienced any seizure.
- •[17] Baseline alanine aminotransferase (ALT) values =2 times the upper limit of normal (ULN) of the performing laboratory or aspartate aminotransferase (AST) values =2 times the ULN or total bilirubin values =1.5 times the ULN at Visit 1.
- •[18] Have leukopenia or history of leukopenia without a clear and resolved etiology or known history of agranulocytosis (absolute neutrophil count <500 mm3, <0.5 GI/L, or <0.5 10E3/µL) during the patient’s lifetime.
- •[19] Prolactin level of >200 ng/mL (>200 ug/L, or >4228 mIU/L) at Visit 1.
- •[20] Have QTc (Bazett’s) >450 milliseconds (males) or >460 milliseconds
- •(females) at Visit 1.
- •[21] Have previously been randomized in this study and/or participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to study entry (Visit 1).
- •[22] Patient is currently prescribed olanzapine and has been taking olanzapine =5 days within 1 month (30 days) prior to Visit 1.
- •[23] Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined
研究者
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