NCT01541605已完成3 期
International Randomised Double-blind Placebo-controlled Study on the Initial Treatment of Acute Mania With Methylphenidate
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 10
- 主要终点
- manic symptoms as assessed by the Young Mania Rating Scale (YMRS)
研究概览
简要总结
This study aims at evaluating the efficacy and safety of methylphenidate in the initial treatment of acute mania in patients with bipolar affective disorders.
详细描述
Mania can be regarded as an autoregulatory mechanism to enhance unstable vigilance. There is increasing evidence that psychostimulants that increase vigilance may be effective in treating mania. However, controlled studies are lacking.
This is a two-arm, randomised, placebo-controlled, double-blind, parallel, multi-centre phase IIIb exploratory study to evaluate the efficacy and safety of methylphenidate in the initial treatment of acute mania in patients with bipolar affective disorders.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent by patients who are competent to consent to study participation.
- •Diagnosis: manic episode according to the International Classification of Diseases 10th Revision (ICD-10): F30.0, F30.1, F31.0 or F31.1
- •Male or female of at least 18 years of age
- •YMRS total score ≥ 20 and ≤ 45 points
- •Body mass index (BMI) > 17
- •Patients must be able to swallow tablets (study drug).
排除标准
- •Any other current major psychiatric ICD-10 disorder is an exclusion criterion except for the following F90, F17.1, F17.2, F40-F59, F60-F69
- •Contraindications for treatment with methylphenidate except as noted otherwise
- •Serious non-psychiatric disease, that may interfere with the objectives of the study or with the safety or compliance of the subject, as judged by the investigator
- •Oral administration of monoaminooxidase (MAO)-inhibitors within two weeks, fluoxetine within 6 weeks and of any other antidepressant or primarily psychotropic substance except for those specified below within one week before study entry.
- •Stable treatment with mood stabilisers including lithium, anticonvulsants (e.g. valproate, carbamazepine) or antipsychotics (e.g. risperidone, olanzapine) or benzodiazepines is NOT an exclusion criterion and will be continued; however, patients receiving more than 2 of these substances are NOT eligible for inclusion
- •Medical history of other disorders of CNS including tics or dyskinesia
- •Medical history of cardiovascular diseases, severe hypertension, glaucoma, hyperfunction of the thyroid
- •Patients with congenital or acquired long QT syndrome, or with a familiy history of QT prolongation, sudden cardiac death or other significant inherited cardiac disorders (e.g. family history of hypertrophic cardiomyopathy).
- •History of Electroconvulsive therapy within the last 3 month
- •Known alcohol and drug addiction or abuse, except for patients with abstinence > 3 month. Patients with sporadic abuse of cannabis (products) will not be excluded from the study. That is even true with a positive Tetrahydrocannabinol (THC) screen in urine.
- •Pregnant or nursing woman
- •Concomitant participation in other clinical trials or participation during the 30 days prior to screening
- •Prior participation in this study
- •Suicidality
研究组 & 干预措施
methylphenidate
Active Comparator
干预措施: methylphenidate (Drug)
placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
manic symptoms as assessed by the Young Mania Rating Scale (YMRS)
时间窗: after 2.5 days of treatment
次要结局
- EEG-vigilance as assessed by the Vigilanz Algorhithm Leipzig (VIGALL)(after 2.5 days of treatment)
- movements as assessed by actimetry(after 2.5 days of treatment)
- cognitive performance as assesd with the Screen for Cognitive Impairment in Psychiatry (SCIP)(after 2.5 days of treatment)
研究者
Michael Kluge
Senior Psychiatrist
University of Leipzig
研究点 (10)
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