A Randomized Open Label Study on the Efficacy, Tolerability, and Total Costs of Olanzapine Versus Conventional Antipsychotics in the Treatment of Acute Mania in Sweden
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Time to remission by Young Mania Rating Scale, MADRS-S and CGI-BP
研究概览
简要总结
The purpose of this study is to test the efficacy and total costs of olanzapine versus commonly used conventional antipsychotics in Sweden.
详细描述
The primary objective is to show that the efficacy of olanzapine is non-inferior to the conventional antipsychotics haloperidol or zuclopentixol in the treatment of an acute manic or mixed episode of bipolar disorder. Efficacy is defined as time to remission, as measured by the total scores of the Young Mania Rating Scale (Y-MRS), MADRS-S, and Clinical Global Impression - Bipolar (CGI-BP). Time from baseline to remission is defined as the primary efficacy measure. Remission is defined as a Y-MRS score <=12 AND a MADRS-S score <=12 AND CGI-BP = 1 or 2.
Secondary efficacy assessments will include time from baseline to
- Response, as defined as a reduction of Y-MRS score greater than or equal to 50% compared to baseline
- Relapse of mania, as defined as a Y-MRS score >= 16 AND CGI-BP >2 after having met the criteria for remission
- Switch into depression, as defined as a MADRS-S score >=17 AND fulfilled criteria for Major Depression as self-assessed by DSRS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of bipolar I disorder and currently display an acute manic or mixed episode (with or without psychotic features)
- •Patients must have a Y-MRS total score of greater or equal to 20 at visit 2
- •Patients must have experienced at least one manic or mixed episode prior to study enrollment
- •Female of childbearing potential must be using a medically accepted means of contraception, or practice sexual abstinence
- •Each patient must have a level of understanding sufficient to communicate intelligently with study personnel
- •Patients must be considered reliable
- •Each patient must understand the nature of the study and signed informed consent
排除标准
- •Female patients who are pregnant or lactating
- •Serious, unstable illnesses such that hospitalization for the disease is anticipated within 3 month or death is anticipated within 3 years
- •Uncorrected hypothyroidism or hyperthyroidism
- •Narrow-angle glaucoma
- •History of allergic reactions or intolerance to study medications
- •DSM-IV substance dependence within the past 30 days at the judgement of the investigator
- •Judged clinically to be at serious suicidal risk
- •Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections prior to visit 2
- •Any patient treated with clozapine within 4 weeks prior to visit 2
- •Subjects who have received treatment with ECT within one month prior to visit 1
研究组 & 干预措施
A
Patients will be given olanzapine
干预措施: olanzapine (Drug)
B
Patients will be given either haloperidol or zuclopentixol
干预措施: haloperidol (Drug)
B
Patients will be given either haloperidol or zuclopentixol
干预措施: zuclopentixol (Drug)
结局指标
主要结局
Time to remission by Young Mania Rating Scale, MADRS-S and CGI-BP
时间窗: 5 months
次要结局
- Euro Qol instrument(5 months)
- Frequency of and time to relapse into mania by Y-MRS and CGI-BP(5 months)
- Adverse events(5 months)
- Resource utilization Clinical Report Form (RUCRF)(5 months)
- Disability free day assessment (DFDA)(5 months)
- Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)(5 months)
- Time to remission in patients with psychotic features by SCID-I judgement, Y-MRS item 8 and PANSS positive items mean sum(5 months)
- Medication compliance(5 months)
- Response by Y-MRS(5 months)
- Frequency of and time to switch to depression by MADRS-S and DSRS(5 months)
- Drug Attitude Inventory (DAI)(5 months)