NCT02698696招募中不适用
Validation of a Cognitive Remediation Program for Bipolar Disorders
Centre hospitalier de Ville-Evrard, France2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from baseline Perceptual Reasoning Index at 3 months
研究概览
简要总结
This study evaluates the effect of a new cognitive remediation program designed for patients suffering from a bipolar disorder, on cognitive functions, psychosocial functioning and neural processes. In this double-blind (patient, outcomes assessor) controlled randomized trial the investigators compare patients receiving the ECo program for bipolar disorders, to patients benefiting from the broadly used cognitive remediation program CRT and to patients receiving supportive psychotherapy. Patients are treated for 3 months and monitored for 9 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Type I or type II Bipolar Disorder diagnosis, according to DSM-IV-TR criteria
- •No Manic or Major Depressive episode during the last three months
- •No or few residual depressive symptoms (HDRS-17 ≤ 12)
- •No or few residual manic symptoms (YMRS ≤ 8)
- •Stable dose of medication for the last two months
- •Cognitive complaint expressed by the patient and impairment observed by the patient's regular psychiatrist
- •Informed consent form read, initialed and signed
- •Patient registered on the social welfare system
排除标准
- •Other diagnosis than Bipolar Disorder on axis I of the DSM-IV-TR
- •Rapid Cycling Bipolar Disorder diagnosis
- •Addiction or substance abuse (except tobacco) during the twelve last months
- •Physical or neurological disorder that can lead to cognitive impairment
- •Engagement in a research protocol either currently or over the last month
- •Neuropsychological assessment or Rorschach Inkblot Test evaluation during the last six months
- •Ineligibility for Magnetic Resonance Imaging [MRI] (e.g. claustrophobia, metallic implants, pace-maker, etc.)
结局指标
主要结局
Change from baseline Perceptual Reasoning Index at 3 months
时间窗: baseline and 3 months
Composite score of the Wechsler Adult Intelligence Scale - fourth edition
Change from 3-months Perceptual Reasoning Index at 9 months
时间窗: 3 months and 9 months
Composite score of the Wechsler Adult Intelligence Scale - fourth edition
次要结局
- Emotion Hexagon(baseline, 3 months and 9 months)
- Key Search Test(baseline, 3 months and 9 months)
- Hamilton Depression Rating Scale(15 days before baseline, 3 months and 9 months)
- Young Mania Rating Scale(15 days before baseline, 3 months and 9 months)
- Functional Repercussions Scale(baseline, 3 months and 9 months)
- Social Desirability Scale(baseline, 3 months and 9 months)
- Social Relationships Scale(baseline, 3 months and 9 months)
- Self-Appraisal of Illness Questionnaire(baseline, 3 months and 9 months)
- Rorschach Inkblot Test(baseline, 3 months and 9 months)
- Change from baseline Event-Related Potentials [ERP] P300 at 3 months during an Oddball task(baseline and 3 months)
- Change from baseline Event-Related Potentials [ERP] N2/P3 complex at 3 months during an emotional Stroop task(baseline and 3 months)
- Change from baseline serum Brain-Derived Neurotrophic Factor [BDNF] level (ng/mL) at 3 months(baseline and 3 months)
- Change from baseline functional Magnetic Resonance Imaging frontal activation at 3 months during an emotion recognition task(baseline and 3 months)
- Processing Speed Index(baseline, 3 months and 9 months)
- Working Memory Index(baseline, 3 months and 9 months)
- Cardebat's Verbal Fluencies(baseline, 3 months and 9 months)
- Rey Auditory Verbal Learning Test(baseline, 3 months and 9 months)
- Stroop Color Word Test(baseline, 3 months and 9 months)
研究者
Clémence ISAAC
Psychologist
Centre hospitalier de Ville-Evrard, France
研究点 (2)
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