Comparison of the Effects of Aripiprazole and Risperidone on the Pattern of Brain Activation in Schizophrenic Patients During Emotional Tasks and With Reference to Controls
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Qualissima
- 入组人数
- 67
- 试验地点
- 4
- 主要终点
- Identification of Brain Circuits Involved in a Task of Emotional Congruence (With fMRI)
研究概览
简要总结
After an initial screening visit, including an assessment of psychiatric disorders, patients stabilized on antipsychotic medication (aripiprazole or risperidone) for at least 6 weeks and control subjects will undergo an assessment using functional magnetic resonance imaging (fMRI) of the differences of patterns of brain activation during an emotional task
详细描述
This study is: interventional, comparative, open label, multi center, without experimental treatment.
Main objective: To evaluate the effect of aripiprazole and risperidone on brain activation during an emotional task of matching patients with schizophrenia, and in reference to control subjects.
Secondary Objective: Comparison of emotional subjective and physiological perception in patients with schizophrenia in relation with their treatment. Comparison of brain activation in patients during the emotional induction task based on symptomatic dimensions, personality traits and performance on cognitive and attentional tests, and for insight capacity . Comparison of transcript level of candidate genes in blood mononuclear cells between the study groups and study the interactions between the observed differences in brain imaging and different levels of transcription of these genes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For patients
- •Men and women, right handed, 18 to 45 years;
- •Having given their written informed consent;
- •Presenting a diagnosis of schizophrenia made by DMS IV, hospitalized or followed regularly in a hospital proper, and whose symptoms are stable for at least 6 weeks, at the discretion of the psychiatrist;
- •Receiving antipsychotic treatment (risperidone or aripiprazole) monotherapy stable (treatment and dose) for at least than 6 weeks;
- •Showing no contra-indication for fMRI;
- •Patients whose physical examination is unremarkable clinically significant;
- •Patients without serious somatic pathology;
- •Affiliated to a social security system.
- •For women of childbearing potential, an appropriate contraception is mandatory and an negative pregnancy test
- •For controls
- •Men and women, right handed, aged 18 to 45 years of age, sex and socio-educational level comparable to patients included;
- •Having given their written informed consent;
- •Do not present a diagnosis of schizophrenia according to DSM IV set;
- •Do not present psychiatric history, and free of any psychotropic medication;
- •Including the physical examination is unremarkable clinically significant;
- •Having no professional musical practice;
- •Affiliated with a social security system.
排除标准
- •For patients
- •Patients in menstruation without effective contraception (oral, intramuscular hormonal, intrauterine device, or surgical);
- •Patients who are pregnant or breastfeeding;
- •Patients not meeting criteria for schizophrenia according to DSM IV criteria or those with resistant schizophrenia (Kane criteria);
- •Introducing a somatic disease or serious neurological, particularly Parkinson's disease, epilepsy, tardive dyskinesia and disabling cardiovascular disease, liver or kidney disease;
- •Presenting a contra-indication to MRI;
- •Having a history of alcoholism or drug addiction during the past year;
- •Participating in another clinical trial or are in a period of exclusion from a previous protocol;
- •Patients likely to have behavioral self aggression from the trial investigators
- •During the study:
- •The investigator considers, for safety reasons, it is in the interest of the patient to be excluded from the study (Hospital readmission due to psychotic symptoms, clinical or psychiatric reasons)
- •Consentment withdrawal
- •The patient does not longer correspond to the inclusion criteria or protocol requirements
- •For controls
- •Women of childbearing potential without effective contraception (oral, intramuscular hormonal, intrauterine device, or surgical);
- •Pregnant or breastfeeding;
- •Presenting a somatic, psychiatric or neurological disorder;
- •Presenting a history of alcohol or substance abuse during the past year;
- •Participating in another clinical trial or are in a period of exclusion from a previous protocol;
- •Presenting a contra-indication to MRI.
结局指标
主要结局
Identification of Brain Circuits Involved in a Task of Emotional Congruence (With fMRI)
时间窗: 3 days after the decision of inclusion
During the fMRI session, the activation of each brain circuits is measured by a "Bold signal" (an arbitrary measure of contrast: numbers of voxels highlighted/activated in the region of interest). The emotional task is composed by congruent and incongruent images. Three effects were caused by the task: congruence, attention and valence effects. Each of them affect, involve and activate the regions of interests differentially within the differents arms. The region of interests who were mainly observed are: Anterior Cingulate Cortex (ACC), Prefrontal dorso-lateral Cortex (PFdlC) and the Amygdala (A).
次要结局
- Assessment of Emotional Reactivity(3 days after the decision of inclusion)
- Assessment of Cognitive and Attentional Abilities(3 days after the decision of inclusion)
- Assessment of Personality Traits(3 days after the decision of inclusion)
- Investigate the Level of Expression of Candidate Genes(one blood sample)