跳至主要内容
临床试验/NCT04757220
NCT04757220招募中不适用

Cognitive and Neural Mechanisms of Multidimensional Apathy in Psychiatric Pathologies

University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2022年1月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
144
试验地点
2
主要终点
Assessment of the motivational form of apathy

研究概览

简要总结

Apathy is defined by quantitative decrease in goal-directed activity in comparison to the person's previous level of functioning. Apathy is a transnosographic symptom, prevalent in many neurological and psychiatric pathologies (specifically in schizophrenia and depression), and almost half of patients suffer from it. It is an important source of burden, affecting both personal and occupational life. Despite its high prevalence and negative consequences, no pharmacological or non-pharmacological treatments exist, the underlying mechanisms of apathy being poorly understood. The main aim of the present study is to advance in our knowledge of cognitive and neural mechanisms of apathy by using a multidimensional model of apathy, distinguishing three forms: executive, emotional and auto-activation/initiative.

the investigators hypothesize, independently of the pathology (schizophrenia and depression), the existence of different cognitive deficits underlying each of the 3 subforms of apathy. Indeed, according to the predictions of Levy and Dubois' model (2006), executive disorders underlie the cognitive form of apathy. It may be related to lesions of the dorsolateral prefrontal cortex and the cognitive territory of the basal ganglia. Emotional apathy could be due to motivational disorder. Dysfunctions or lesions in the orbital and medial prefrontal cortex and limbic territories of the basal ganglia may underlie this. Finally, the initiative form, may be a mixed form, with both motivational and executive difficulties. Lesions or dysfunctions may affect both the cognitive and limbic territories of the basal ganglia or the anterior cingulate cortex.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Other
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

入选标准

  • Inclusion criteria (all subjects):
  • age between 18 and 60 years
  • men or women volunteers, hospitalized or not
  • subject affiliated to an health insurance
  • subject having signed an informed consent
  • Inclusion criteria (for schizophrenic patients):
  • - presence of DSM-V TR criteria for schizophrenia (American Psychiatric Association, 1994)
  • Inclusion criteria (for depressive patients):
  • - presence of DSM-V TR criteria for depression (American Psychiatric Association, 1994)

排除标准

  • a major or non stabilized somatic disorder
  • medical history likely to affect cerebral anatomy or linked to an abnormality (neonatal distress, neurochirurgical intervention, neurological disorders, stroke attack)
  • any disorders involved in the use of a psycho-active substance (as defined by the DSM-IV)
  • sensory disabling impairments, and specifically visual acuity < 8
  • general anaesthesia during the 3 months before the study
  • pregnancy (declared by the subject)
  • persons in an emergency situation
  • persons deprived in any way of their liberty
  • persons in period of exclusion in an other protocol
  • Exclusion criteria (for controls):
  • - use of psychotropic substance during the 3 weeks before the study
  • Exclusion criteria (for patients):
  • - use of benzodiazepines

研究组 & 干预措施

Patients with schizophrenia

Experimental
  • 5 subjective questionnaires
  • 4 cognitive tasks with EEG recordings

干预措施: Cognitive tasks with EEG recording (Other)

Patients with depression

Experimental
  • 5 subjective questionnaires
  • 4 cognitive tasks with EEG recordings

干预措施: Cognitive tasks with EEG recording (Other)

Healthy controls

Active Comparator
  • 5 subjective questionnaires
  • 4 cognitive tasks with EEG recordings

干预措施: Cognitive tasks with EEG recording (Other)

结局指标

主要结局

Assessment of the motivational form of apathy

时间窗: first baseline visit

The severity of the forms of apathy (Executive, Emotive and Initiation apathy) will be measured by using The Dimensional Apathy Scale (DAS) (Radakovic and Abrahams, 2014) and the Lille Apathy Rating Scale (LARS) (Sockeel et al., 2006) Items are scored on a 4-point Likert scale based on the frequency of occurrence of the apathetic symptoms in the previous month. 3 scores will be obtained, one for each form of apathy. A high score (maximum, 24) indicates a severe form of apathy.

Assessment of the cognitive form of apathy

时间窗: first baseline visit

The severity of the forms of apathy (Executive, Emotive and Initiation apathy) will be measured by using The Dimensional Apathy Scale (DAS) (Radakovic and Abrahams, 2014) and the Lille Apathy Rating Scale (LARS) (Sockeel et al., 2006) Items are scored on a 4-point Likert scale based on the frequency of occurrence of the apathetic symptoms in the previous month. 3 scores will be obtained, one for each form of apathy. A high score (maximum, 24) indicates a severe form of apathy.

Assessment of the behavioural form of apathy

时间窗: first baseline visit

The severity of the forms of apathy (Executive, Emotive and Initiation apathy) will be measured by using The Dimensional Apathy Scale (DAS) (Radakovic and Abrahams, 2014) and the Lille Apathy Rating Scale (LARS) (Sockeel et al., 2006) Items are scored on a 4-point Likert scale based on the frequency of occurrence of the apathetic symptoms in the previous month. 3 scores will be obtained, one for each form of apathy. A high score (maximum, 24) indicates a severe form of apathy.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (2)

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