Neuropsychological Characterization of Patients With Bipolar Disorder and a History of Suicide Attempt
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Columbia-Suicide Severity Rating Scale (C-SSRS)
研究概览
简要总结
The main objective of this study is to evaluate decision-making using the Iowa Gambling Task (IGT) among patients with euthymic bipolar disorder according to their personal history of suicide attempt ("suicidal" vs. "not suicidal ").
详细描述
The secondary objectives of this study are:
A. Evaluate other aspects of cognitive functioning (using the Tower of London, the Probabilistic Reversal-learning task, the Rey Complex Figure, the Reading the Mind in the Eyes test) in euthymic patients with bipolar disorder, depending on the presence or absence of a history of suicide attempt; B. Explore performance on neuropsychological tests depending on the type of therapy administered (lithium salts or valproate monotherapy or in combination with other mood stabilizers); C. Explore a possible relationship between circulating levels of lithium or sodium divalproex results and different neuropsychological tests; D. Establishment of a biobank for this population with leftover blood samples following serum lithium or divalproex testing.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •The patient was correctly informed about the study
- •The patient must be insured or beneficiary of a health insurance plan
- •The diagnosis of bipolar disorder is confirmed by the doctor referring the patient to the BEC and confirmed during the preliminary interview at the BEC
- •The patient is euthymic on the day of inclusion. This is supported by a short psychiatric interview conducted at the BEC and the completion of the depression and mania scales (score <= 7 on the HDRS questionnaire and score <= 7 on the YMRS questionnaire).
- •The patient is prescribed a mood stabilizer based on lithium or divalproex.
排除标准
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient formalizes his/her opposition to the studyd
- •It is impossible to correctly inform the patient
- •The patient has mental retardation
- •The patient has practiced substance abuse or dependence within the 6 months prior to study inclusion (alcool, cannabis, opiates, psychostimulants)
- •The patient does not meet euthymic criteria (score <= 7 on the HDRS questionnaire and score <= 7 on the YMRS questionnaire).
- •Uninclusion Criteria:
- •The patients withdraws consent during the study
- •The patient does not understand directions necessary for the neurpsychological tasks
- •The patient is not able to use a computer to complete the neuropsychological tasks
结局指标
主要结局
Columbia-Suicide Severity Rating Scale (C-SSRS)
时间窗: Baseline (day 0)
The Iowa Gambling Task
时间窗: Baseline (day 0)
次要结局
- The Rey Osterreith Complex Figure Task(Baseline (day 0))
- Serum concentration for lithium (mEq/l)(Baseline (day 0))
- The Tower of London Test(Baseline (day 0))
- The Probabilistic Reversal Learning Task(Baseline (day 0))
- The Baron-Cohen Test(Baseline (day 0))
- Serum concentration for divalproate (mg/l)(Baseline (day 0))