NCT00982020已完成4 期
A Long-Term, Open-Label, Safety Study of Oral Olanzapine in Adolescents With Bipolar I Disorder (Manic or Mixed Episodes) or Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants
研究概览
简要总结
Open-label safety study of oral olanzapine treatment in adolescents, aged 13 to 17 years, with bipolar I disorder (manic or mixed episodes) or schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have a diagnosis of bipolar I disorder and display an acute manic or mixed episode (with or without psychotic features) or a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR)and confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime (K-SADS-PL).
- •Participants with a diagnosis of schizophrenia must obtain a Brief Psychiatric Rating Scale for Children (BPRS-C) total score >30, with a minimum score of 3 on at least one of the following items at both screening and randomization - hallucinations, delusions, peculiar fantasies.
- •Participants with a diagnosis of bipolar I disorder must have a Young Mania Rating Scale (YMRS) total score greater than or equal to 15 at both screening and randomization.
- •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 participant to perform all tests and examinations required by the protocol, and understands the nature of the study.
排除标准
- •History of mental retardation, current comorbid autism, or current comorbid Pervasive Developmental Disorder.
- •Have DSM-IV-TR substance (except nicotine and caffeine) dependence within the past 30 days prior to randomization.
- •Been judged clinically to be at any suicidal risk.
- •History of allergic reaction or hypersensitivity to olanzapine.
- •Receiving current pharmaceutical treatment for weight management or are participating in a structured behavioral diet and/or exercise weight loss program.
- •Other antipsychotics, mood stabilizers, or anticonvulsants (for mood stabilization) used for the primary study conditions (bipolar I disorder or schizophrenia)
- •Have acute, serious, or unstable medical conditions
- •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).
- •Have had one or more seizures without a clear and resolved etiology.
- •Baseline alanine aminotransferase (ALT) values greater than or equal to 2 times the upper limit of normal (ULN) of the performing laboratory or aspartate aminotransferase (AST) values greater than or equal to 2 times the ULN or total bilirubin values greater than or equal to 1.5 times the ULN at screening.
- •Have leukopenia or history of leukopenia without a clear and resolved etiology or known history of agranulocytosis (absolute neutrophil count <500 cubic millimeter [mm^3], <0.5 GI/L, or <0.5 10E^3/microliters [μL]) during the participant's lifetime.
- •Prolactin level of >200 nanograms per milliliter (ng/mL) [>200 micrograms per liter (ug/L), or >4228 milli-International unit per liter (mIU/L)] at screening.
- •Have QTc (Bazett's) >450 milliseconds (males) or >460 milliseconds (females) at screening.
- •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 screening.
- •Currently prescribed olanzapine for greater than or equal to 5 days within 1 month (30 days) prior to screening.
- •Are investigator site personnel directly affiliated with this study and/or their immediate families OR are employed by or representatives of Lilly.
- •Pregnant or nursing.
- •Have received treatment within the last 30 days with an investigational new drug that has not received regulatory approval for any indication at the time of study entry.
- •Treatment with clozapine within 14 days prior to randomization.
- •Participants who have used olanzapine (that is, oral olanzapine, intramuscular [IM] olanzapine, or olanzapine orally disintegrating tablets) and have had treatment withdrawn due to clinically significant and/or intolerable adverse effects, or who have exhibited a lack of efficacy/response to treatment to olanzapine including treatment resistance.
研究组 & 干预措施
Olanzapine/standard behavioral weight intervention
Experimental
干预措施: Olanzapine (Drug)
Olanzapine/standard behavioral weight intervention
Experimental
干预措施: Standard behavioral weight intervention (Behavioral)
Olanzapine/intense behavioral weight intervention
Experimental
干预措施: Olanzapine (Drug)
Olanzapine/intense behavioral weight intervention
Experimental
干预措施: Intense behavioral weight intervention (Behavioral)
结局指标
主要结局
Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants
时间窗: Baseline, 52 weeks
次要结局
- Mean Change From Baseline to Endpoint in Body Mass Index (BMI) for Participants With Duration of Treatment of at Least 6 Months(Baseline, 52 weeks)
- Time to Event for 7%, 15%, and 25% Weight Gain for All Participants(Baseline up to 52 weeks)
- Mean Change From Baseline to 52 Weeks in Adolescent Structured Young Mania Rating Scale (YMRS) for Participants With Bipolar I Disorder(Baseline, 52 weeks)
- Mean Clinical Global Impression of Improvement (CGI-I) at 52 Weeks for All Participants(52 weeks)
- Mean Change From Baseline to 52 Weeks in Waist Circumference for All Participants(Baseline, 52 weeks)
- Mean Change From Baseline to 52 Weeks in Clinical Global Impression - Severity (CGI-S) for All Participants(Baseline, 52 weeks)
- Mean Change From Baseline to 52 Weeks in Anchored Version of the Brief Psychiatric Rating Scale for Children (BPRS-C) for Participants With Schizophrenia(Baseline, 52 weeks)
研究者
研究点 (1)
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