NCT01075126撤回4 期
Depakote Vs. Lithium in African Americans With Bipolar Disorder
Lawson, William B., M.D., PhD, DFAPA2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2006年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- psychopathology: YMRS, MADRS
研究概览
简要总结
It is hypothesized that Depakote will be better tolerated then lithium in treating African Americans with bipolar disorder.
详细描述
This is a 14 week randomized open study of 50 inpatients or outpatients with bipolar I r II. African American subjects will receive lithium or depakote ER. Measures will be made of psychopathology, reported side effects, and study completers. Measures will also be made of RBC/plasma lithium to determine if this level is better predictive of lithium tolerability.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Females must be using a contraceptive
- •Understand and sing informed consent
- •Meet criteria for DSM IV bipolar I or II
- •Must have been receiving treatment with depakote or lithium for at least 4 weeks
- •Must not have used illicit substances 48 hours before the study
排除标准
- •Not takin g lithium o valproate at time of screening
- •Alcohol intoxicated or using drugs of abuse other then cannibis
- •Presence of psychotic features
- •Participation in clinical trail within 1 month of study
- •Female subjects pregnant or nursing
- •Serious unstable medical or psychiatric illness
- •Uncorrected hypothyroidism or hyperthyroidism
- •Seizures without a clear and resolved etiology
- •Hypersensitivity or intolerance to lithium or valproic acid
- •Treatment with injectable depot neuroleptic less then one dosing interval
- •Treatment with reversible MAOI, guanethidine, or guanadrel within i week of study
- •Treatment with fluoxetine within 8 weekS of study
- •treatment with clozapine or ECT 3 months prior to study
- •current diagnosis of schizophrenia or other psychotic disorder
- •judged to be at serious suicidal risk
结局指标
主要结局
psychopathology: YMRS, MADRS
Tolerability: Uku side effect rating, drop out rate, failure to switch rate
次要结局
- HAMD, CGI-BP, HAM A,CORE, MADRS
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Bimatoprost Versus Travoprost at Cairo UniversityGlaucomaOcular HypertensionNCT01092273Cairo University
招募中
4 期
Liposomal Bupivacaine Vs Bupivacaine with Dexmedetomidine in Erector Spinae Plane Blocks for MastectomiesBreast CancerNCT06252662United States Naval Medical Center, Portsmouth200
已完成
不适用
Comparable study between bimatoprost and latanoprost/timolo fixed combination in primary open angle glaucoma patientsPrimary open angle glaucoma patientsJPRN-UMIN000004595Department of Ophthalmology, Kyoto Prefectural University of Medicine80
尚未招募
2 期
Role of Alpha agonists in relief of labour paiCTRI/2020/10/028645Shruti kabi
已完成
4 期
Aprepitant With Dexamethasone Versus Ondansetron With Dexamethasone for PONV Prophylaxis in Patients Having CraniotomyPostoperative Nausea and VomitingNCT00734929Duke University115