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临床试验/NCT02378818
NCT02378818Unknown不适用

SCHIZOBAT/DEPBAT : Characterization of the Motivational Deficit in Schizophrenia and Depression

Centre Hospitalier St Anne2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2014年11月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
140
试验地点
2
主要终点
level of force produced based in incentive reward

研究概览

简要总结

This research focuses on disorders of motivation, responsible for a disability that patients experience daily. It is a disorder that affects behavior, especially social. Mechanisms, which result in these disorders, are poorly understood. This ignorance is responsible for the lack of effective therapy. The investigators realize this work in order to better understand the motivational deficits. The objective of the study is to characterize the cognitive mechanisms of motivational deficits in schizophrenia and depression. To answer the question posed in the research, it is planned to include 35 people with schizophrenia, 35 people with depression and 70 heathy volunteers in the Hospital of Sainte-Anne .

详细描述

The investigator goal is to develop a neuropsychological battery to characterize the different aspects of motivation: energizing action, ability to use the clues to assign value, ability to anticipate a reward delayed in time, and finally learning by trial / error based rewards. In addition, the investigators systematically compare the effect of rewards and punishments (losses) in these spots. Such a systematic approach should better understand the nature of disrupted in schizophrenia process. It should also highlight the differential effects of treatment, including the effects of conventional antipsychotics versus atypical antipsychotics, but also the benefits of cognitive remediation.

In the depression:

The motivational deficit is at the heart of the depressive symptomatology. Our objective is to characterize the motivational processes altered in the depression thanks to the same neuropsychological battery. Furthermore, this clinical dimension could influence the answer to the antidepressant treatment. A better characterization of the motivational deficit would allow to adapt at best the pharmacological treatments used in the depression, in particular by targeting the dopaminergic way, involved in the control of the motivation.

The investigators will recruit 35 patients and 35 control subjects in both populations. The investigators will make them pass a battery of motivational tests described above on three half-days:

  • Force task: This task tests the energization process, that is to say the ability to activate an action in proportion to what is involved.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
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

入选标准

  • (schizophrenia group) :
  • Patients :
  • Age between 18 and 65 years
  • Affiliation to a healthy insurance
  • Subjects who were informed and willing to sign the form of free and informed consent and information of the curator if necessary (or consent of the tutor)
  • French native tongue
  • Diagnosis of schizophrenia according to ICD-10, made by a psychiatrist. The subjects are stabilized (less than three items include a score> = 4 or to the positive level (P) of the PANSS)
  • Unchanged psychotropic treatment for at least three months before inclusion, a minimal dose adjustment in the last month is tolerable.
  • Healthy volunteers:
  • Age between 18 and 65 years
  • Affiliation to a healthy insurance
  • Subjects who were informed and willing to sign the form of free and informed consent and information curator appropriate
  • French native tongue

排除标准

  • (schizophrenia group) :
  • Patients:
  • Unable major, persons deprived of liberty, pregnant women
  • Enforced hospitalisation
  • Recent abuse (1 week) or chronic use of addictive substances, except tobacco
  • Treatment electro-convulsivo-therapy in the last 6 months
  • Degenerative Pathology, neurological disorder
  • Co-occurrence of a major depressive episode in a schizophrenic patient evaluated by a score> 10 CDS
  • Difficulty in understanding and expression in French language
  • Deficit of visual acuity or uncorrected hearing
  • Healthy volunteers:
  • Unable major, persons deprived of liberty, pregnant women
  • Current psychiatric disease
  • Psychotropic treatment
  • Recent abuse (1 week) or chronic use of addictive substances, except tobacco
  • Difficulty in understanding and expression in French language
  • Deficit of visual acuity or uncorrected hearing
  • Mental retardation
  • Inclusion Criteria (depression group) :
  • Patients :
  • Age between 18 and 75 years
  • Affiliation to a healthy insurance
  • Subjects informing and accepting to sign the free and lit consent form and information of the curator if necessary or consent of the tutor
  • French Mother tongue
  • Diagnosis of major depressive episode following the CIM-10, put by a psychiatrist.
  • Healthy volunteers:
  • age between 18 and 75 years
  • Affiliation to a healthy insurance
  • Subjects informing and accepting to sign the free and lit consent form
  • French mother tongue
  • Exclusion Criteria (depression group) :
  • persons deprived of liberty , pregnant women
  • Admission under constraint
  • Recent Abuse ( 1 week) or consumption chronicles of addicting substances, except the tobacco
  • Treatment by electroconvulsivo-therapy
  • Degenerative Pathology or obvious neurological disorder
  • Diagnosis of schizophrenia or disorder of personality severe
  • Difficulties of understanding and expression in French language
  • Uncorrected visual or hearing Deficit of acuteness
  • Healthy volunteers:
  • Incapable, persons deprived of liberty, pregnant women
  • Recent Abuse (1 week) or consumption chronicles of addicting substances, except tobacco
  • Personal psychiatric Histories
  • Current psychiatric Disorder
  • Current psychotropic Treatment

研究组 & 干预措施

Healthy volunteers (depression)

Other

干预措施: Force task, preference task, discount task, learning task. (Behavioral)

Schizophrenia patients

Other

35 patients, Age between 18 and 65 years, with a diagnosis of schizophrenia and unchanged psychotropic treatment for at least three months before inclusion.

干预措施: Force task, preference task, discount task, learning task. (Behavioral)

Healthy volunteers (schizophrenia)

Other

35 healthy volunteers

干预措施: Force task, preference task, discount task, learning task. (Behavioral)

Depressive patients

Other

干预措施: Force task, preference task, discount task, learning task. (Behavioral)

结局指标

主要结局

level of force produced based in incentive reward

时间窗: up to third day

次要结局

  • The proportion of choosing the expensive option (great effort/big time/immediate effort)(the first inclusion day)
  • consistent level of choice questionnaire(the first inclusion day)
  • The proportion of corrects choice(the first inclusion day)

研究者

发起方
Centre Hospitalier St Anne
申办方类型
Other
责任方
Sponsor

研究点 (2)

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