EUCTR2008-000281-23-GB进行中（未招募）1 期
Melatonin in Acute Mania Investigation (MIAMI-UK) - Melatonin in Acute Mania Investigation Version 3.0
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
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
入选标准
- •Inclusion Criteria: • In or outpatients meeting DSM-IV criteria for bipolar disorder type 1 or 2 • Currently experiencing manic or hypomanic symptoms. • Minimum score on Young Mania Rating Scale (YMRS) (>/=20) • Informed consent possible or previously obtained. • Willing to allow his or her General Practitioner and consultant to be notified of participation in the study. • Aged 18-65
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •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
- •Exclusion Criteria: The participant may not enter the study if ANY of the following apply: • Clinically significant illicit substance or alcohol misuse where dependence criteria are satisfied – craving on abstinence, withdrawal symptoms develop and are relieved by the substance, an effect on the behavioural activity of the individual to procure the substance on a predictable basis and an effect on the socio-occupational or relational functioning of the individual. • Comorbid Axis 1 disorders (according to DSM-4 Diagnostic Classification system). • Significant abnormalities on physical examination at the commencement of the trial, necessitating further investigation by a General Practitioner. • Patients currently taking Beta-blocker type medication . Patients suffering from auto-immune disease. • Patients taking the SSRI anti-depressant fluvoxamine, 5- and 8- methoxypsoralens, hormonal medications, quinolones or cimetidine, as these could interact with the drug to increase melatonin levels. • Patients taking carbamazepine or rifampicin, as these could interact with the drug to reduce melatonin levels.. . Females who are pregnant or breast-feeding. . Patients who have to undertake tasks where drowsiness could increase risk.
研究者
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