NCT00050206已完成4 期
Olanzapine Versus Placebo in the Treatment of Mania in Adolescents With Bipolar I Disorder
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Assess the efficacy of a flexible dose of olanzapine compared with placebo in the treatment of mania in bipolar I disorder (manic or mixed episode associated with bipolar I disorder, with or without psychotic features) in adolescents
研究概览
简要总结
The purpose of this study is to determine the efficacy (how well the drug works), safety, and any side effects of olanzapine compared to placebo in the treatment of mania in bipolar disorder in adolescents. Both the potential benefits and side effects of olanzapine will be evaluated throughout this trial.
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
- Double
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
- •Male or female patients, 13 to 17 years of age who must not yet have reached their 18th birthday prior to Visit 1, when informed consent is obtained.
- •Patients must have a diagnosis of bipolar I disorder and currently display an acute mania or mixed episode.
- •Both the patient and the patient's parent/authorized legal representative must understand the nature of the study and must sign a document granting consent.
- •Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test.
排除标准
- •Female patients who are either pregnant or nursing.
- •Current diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder.
- •Patient with acute or unstable medical conditions, such that intensive care unit hospitalization for the disease is anticipated within 6 months.
- •Patients who have previously not responded to an adequate dose and/or duration of olanzapine treatment.
- •Patients who have been judged clinically to be serious suicidal risks.
结局指标
主要结局
Assess the efficacy of a flexible dose of olanzapine compared with placebo in the treatment of mania in bipolar I disorder (manic or mixed episode associated with bipolar I disorder, with or without psychotic features) in adolescents
次要结局
- Assess additional efficacy as measured by Y-MRS,CGI-BP Severity of Illness, CGI-BP Severity of Illness (CGI-BP Severity of Mania, CGI-BP Severity of Depression, and CGI-BP Severity Overall)
- Assess additional efficacy as measured by Children's Depression Rating Scale-Revised (CDRS- R);Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IVPI) and Overt Aggression Scale (OAS).
- Assess the safety of olanzapine and quality of life associated with olanzapine compared with placebo.
- Compare the frequency of response of up to 3-weeks, double-blind treatment and up to an additional 26 weeks of open-label olanzapine treatment
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Olanzapine Versus Placebo in the Treatment of Adolescents With SchizophreniaSchizophreniaNCT00051298Eli Lilly and Company107
已完成
3 期
Olanzapine Treatment of Patients With Bipolar I DisorderDepression, BipolarNCT00510146Eli Lilly and Company514
已完成
3 期
Efficacy and Safety of Olanzapine in Patients With Borderline Personality DisorderBorderline Personality DisorderNCT00088036Eli Lilly and Company450
已完成
3 期
Olanzapine in Patients With Borderline Personality DisorderBorderline Personality DisorderNCT00091650Eli Lilly and Company300
已完成
3 期
Safety and Efficacy Trial of Olanzapine in Outpatients With Pathological GamblingPathological GamblingNCT00438776Lindner Center of HOPE42