Automatic Measurement of Antipsychotic Medication Adherence in Schizophrenia Through Speech (OBSERVSPEECH)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Voice interviews recorded on Callyope application
研究概览
简要总结
Schizophrenia is a serious psychiatric illness affecting approximately 25 million people worldwide. Patients with schizophrenia experience hallucinations, auditory illusions, disordered thinking, movement disorders, cognitive impairment and social isolation. Treatments with antipsychotics have proven effective in improving their living conditions, but poor compliance results in relapses and rehospitalizations for the majority of patients, which often results in a worsening of residual symptoms. The prevention of these relapses is a major issue in the care of these patients and frequent monitoring is necessary. The use of a simple, rapid and inexpensive tool to monitor symptoms and treatment effect in schizophrenia could improve the effectiveness of the treatment of these patients and prevent relapses. Speech is a good candidate as a biomarker in the monitoring of patients with schizophrenia. Schizophrenia is accompanied by speech disorders including poor speech, variations in tone or intensity or even difficulties in organizing speech.
详细描述
Schizophrenia is a highly complex disease of unknown origin. It is characterized by a heterogeneous etiology and variable clinical manifestations. Numerous studies have investigated genetic, biochemical or neurodevelopmental factors of the pathology, without providing a definitive answer. The environmental factor is also analyzed, especially urban density and pollution. Finally, the immune pathway, in particular neuroinflammation, has been studied. Certain parasites, such as Toxoplasma, may be involved in the development of schizophrenia in combination with genetic factors. All these studies tend to show that the parasite/gene/environment association would influence the development of schizophrenia, but the origins remain unclear and a more complete knowledge of the pathophysiology is needed to improve diagnosis and patient management through new therapeutic targets.
More than 80% of patients with schizophrenia have language abnormalities. These abnormalities are manifested in syntax, semantics and phonology. The most common include monotonous intonation, poverty of speech, increased pauses, lack of spontaneity, and disruption of speech coherence. As speech is an important factor in social interaction, patients have great difficulty in maintaining their social relationships.
A major problem in schizophrenia is the discontinuation or misuse of antipsychotic treatment, which leads to relapse and additional hospital costs. According to a 2013 study, 50% of patients discontinue treatment after six months, often leading to decompensations.To avoid relapses, clinicans can either administer hetero-questionnaire to monitor the patients' symptoms or monitor treatment adherence.
To monitor symptoms, clinicians have at their disposal various standardized questionnaires such as the PAANS. However, those tests are time-intensive.
To monitor treatment adherence, clinicians can use blood drug concentrations as an evidence of compliance, although this method is invasive, and requires costly administration coordination between healthcare profesionnals and patients. There are also several standardized tests to monitor adherence, such as the clinician-administered BARS questionnaire and the self-administered BEMIB. These measures have often been criticized due to factors such as recall bias and poor self-perception, which limit the accuracy of patient reports and overestimate adherence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Affiliated to a social security or other social protection scheme
- •Diagnosed with schizophrenia according to the DSM-5 (code F20)
- •Stable state without duration criteria
- •Main treatment with risperidone or paliperidone, aripiprazole, olanzapine in oral or long-acting injectable form
- •Complementary treatment with an antipsychotic for anxiolytic or sedative purposes: chlorpromazine, loxapine or cyamemazine
- •Able to speak and read French
- •Able to perform speech evaluations
- •Able to answer questionnaires on smartphone
- •May be under curatorship or guardianship
- •Agreeing to participate in the study and with informed consent signed by the subject, as well as by the legal representative in the case of a person under curatorship or guardianship
排除标准
- •Suffering from a pathology that impairs French
- •Suffering from a neurological pathology: multiple sclerosis, Parkinson's disease, Huntington's disease or neurodegenerative disease
- •Treatment with lithium salts
- •Anti-epileptic treatment
- •Participant in another study involving medication
研究组 & 干预措施
Schizophrenic patients treated with a primary treatment
Study's interventions:
- 4 blood tests (inclusion visit, at follow-up visits at 2 and 4 months after inclusion, at the end-of-study visit at 6 months after inclusion) to measure the blood concentration of antipsychotic treatment (risperidone or paliperidone)
- completion of self-questionnaires and voice interviews of the application developed by CALLYOPE
干预措施: Voice interviews and questionnaires carried out via the CALLYOPE application (Other)
结局指标
主要结局
Voice interviews recorded on Callyope application
时间窗: Month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
The analysis of the interviews (acoustic and linguistic features) will be implemented in a voice model predicting a score.
Plasma concentration of antipsychotics
时间窗: Month 0, Month 2, Month 4, Month 6
Plasma concentration of antipsychotics measured in ng/mL from Month 0 to Month 6.
次要结局
- Total sleep duration(From enrollment to the end of study at 6 months)
- Age(Month 0)
- Weight(Month 0)
- Sex(Month 0)
- Change from Baseline in the schizophrenia severity(Month 0, Month 2, Month 4, Month 6)
- Changes from Baseline in the schizophrenia severity(Month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6)
- Number of hospitalizations(From enrollment to the end of study at 6 months)
- Duration of daily physical activity(From enrollment to the end of study at 6 months)
- Phases of sleep duration(From enrollment to the end of study at 6 months)
- Plasma concentration of sedative antipsychotics(Month 0, Month 2, Month 4, Month 6)
- Daily travel distance(From enrollment to the end of study at 6 months)
- Changes from Baseline in the symptoms (Depression, anxiety, functional autonomy, fatigue)(Month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6)
- Changes from Baseline in feelings of loneliness or social isolation(Month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6)