NCT00431522已完成4 期
Protective Effect of Valproate on Brain Cells:A Magnetic Resonance Imaging and Spectroscopy Study in Patients With Bipolar Disorder Diagnosis
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- To assess regional N-acetyl aspartate (NAA) levels in drug free bipolar patients either in manic/hypomanic, or depressive or euthymic state
研究概览
简要总结
- To determine the total and local gray matter volumes, and N-acetyl aspartate (NAA) levels in patients with bipolar disorders who are within euthimic, depressive or manic/hypomanic period and who are not taking drug;
- To investigate the neuroprotective effects of long-term (6 weeks) use of valproate on total and local gray matter volumes and NAA levels.
- To measure the brain electrical response to visual and auditory impulses before and after valproate treatment in patients within euthimic, depressive or manic/hypomanic period and who are not taking drug, and to compare the data with each other and with normal groups.
- To determine the cognitive functions before and after the valproate treatment in the same patient group, to compare the data with each other and with age- and sex-paired normal controls;
- To determine the relationship between these effects of valproate and clinical improvement;
- To investigate the relationship between cognitive ability status and electrical activity of brain, to compare this with that in control group; to determine the relationship between the data and brain imaging (MRI/MRS) findings in conjunction with localization
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of type I or II bipolar disorder according to DSM-IV after stratified SCID I interview,
- •being currently euthimic (for at least one month), manic-hypomanic and having YMRS points of 15 or more, or being in depressive episode and having HAM-D21 points of 15 or more
- •being not taking drugs for at least two weeks before participating in the study (except benzodiazepins)
排除标准
- •female who are pregnant or planning to be pregnant, nursing
- •having known hypersensitivity to study drug
- •being given any psychotropic agent other than benzodiazepine within the last two weeks
- •active sustance or alcohol usage within the last two weeks, or substance addiction other than cafein or nicotine (within the last month)
- •having another axis I disorder such as comorbid dementia, delirium, obsessive compulsive disorder, eating disorder
- •having unstabilised hepatic or renal disorder, thyroid or blood disease
- •having history of cerebral surgery
- •existence of a degenerative neurologic disease or epilepsy
- •having pacemaker
- •having a prosthesis able to magnetic effect in eye, brain or sites near to these regions
- •homicide thougths or severe catatonia required to be hospitalized
- •having mixed episode
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
To assess regional N-acetyl aspartate (NAA) levels in drug free bipolar patients either in manic/hypomanic, or depressive or euthymic state
时间窗: for 6 weeks
To investigate valporate's effect on total and regional gray matter volume and NAA levels;
时间窗: for 6 weeks
次要结局
- To assess evoked and event related potentials to visual and auditory stimuli in patients before and after valproate monotherapy in comparison to healthy controls(for 6 weeks)
- To determine the relationship between clinical improvement and image data changes in depressed or manic/hypomanic patients,(for 6 weeks)
研究者
研究点 (2)
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