ANTICIPATING DEPRESSIVE AND MANIC EPISODES IN BIPOLAR DISORDERS USING VOCAL BIOMARKERS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 170
- 主要终点
- Occurrence of relapses during the study period
研究概览
简要总结
Bipolar disorder (BD) is a chronic, cyclical mental illness affecting over 1% of the global population. It is characterized by alternating episodes of elevated mood and energy (mania or hypomania) and episodes of decreased mood and energy (depression).
Manic episodes involve hyperactivity, decreased need for sleep, grandiosity, accelerated speech, and sometimes psychotic symptoms such as hallucinations or delusions. Depressive episodes, in contrast, are characterized by sadness, low energy, social withdrawal, sleep and appetite disturbances, and low self-esteem. Bipolar patients are at very high risk of suicide, with rates up to 20 times higher than in the general population; nearly half will attempt suicide during their lifetime, and 15-20% of these attempts are fatal.
BD is associated with a substantial decrease in quality of life, often greater than that seen in other mood or anxiety disorders. This reduction is primarily driven by depressive symptoms, including residual ones that may persist during remission periods. The frequent comorbidity with anxiety disorders further exacerbates the burden of the illness.
Recently, research has turned toward the concept of the digital phenotype to identify early markers of relapse using passive and continuous monitoring. Among potential digital biomarkers, voice has shown particular promise. Automated speech analysis, combined with machine learning algorithms, has demonstrated effectiveness in detecting psychiatric symptoms and differentiating mood states. In BD, vocal and linguistic patterns vary with mood fluctuations, suggesting that voice could serve as a sensitive indicator of relapse risk.
The main hypothesis of the present study is that automated analysis of speech and lifestyle data can help develop a predictive model capable of identifying early signs of relapse, whether manic, depressive, or mixed, or transitions to high-risk states in individuals with bipolar disorder.
详细描述
Bipolar disorder (BD) is a chronic and cyclical illness that affects a significant portion of the population, representing more than 1% worldwide. It is characterized by alternating episodes of elevated mood and energy (mania or hypomania) and episodes of decreased mood and energy (depression). These mood episodes manifest as substantial variations in energy levels and behavior, which recur over time and have a major social and occupational impact. According to the World Health Organization, BD rank as the fourth leading cause of morbidity and mortality.
Manic episodes are marked by hyperactivity, exalted mood, insomnia, inflated self-esteem, expansive speech and behavior, and sometimes psychotic symptoms (such as delusions of persecution or hallucinations). In contrast, depressive episodes are characterized by low energy, sadness, social withdrawal, hypersomnia or insomnia, and low self-esteem, often accompanied by weight loss or gain and decreased or increased appetite. The risks associated with manic, depressive, or mixed episodes are numerous; notably, individuals with BD have a suicide rate up to 20 times higher than that of the general population. Nearly half of patients with BD will attempt suicide at least once in their lifetime, and 15-20% of these attempts are fatal.
BD are associated with a marked reduction in quality of life, often greater than that observed in other mood or anxiety disorders. This decrease in quality of life is more strongly correlated with depressive symptoms than with manic or hypomanic symptoms. Furthermore, poor quality of life is related to residual depressive symptoms that may persist during remission periods, as well as to the high comorbidity of bipolar disorder with anxiety disorders.
The annual relapse rate ranges between 40% and 61% during the first two years following the initiation of treatment. This high incidence of relapse makes stabilization particularly difficult for patients with BD, with a period of significant vulnerability following each episode. The average duration of hospitalization is 58 days, at an approximate cost of €850 per day, resulting in direct hospitalization costs related to mood disorder relapses of about €3 billion per year. According to the French Court of Auditors, for every euro of direct cost, there are two euros of indirect costs related to social benefits and the negative impact on employment. Extrapolating these figures, the cost of hospitalizations due to relapses in BD is estimated at €45 billion across Europe.
Moreover, each relapse or rehospitalization irreversibly affects the individual's cognitive functioning and contributes to social and occupational disintegration. Staging models of the illness based on neuroprogression have been developed, taking into account the number of relapses and the degree of functional impairment. However, these models are not yet implemented in clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient
- •Patient capable of providing informed consent
- •Patient suffering from bipolar disorder according to DSM-5-TR (2022) criteria
- •Patient recently discharged from hospitalization or in remission after a mood episode within the last 12 months, with a MADRS score ≤10 and a YMRS score ≤8, or based on the psychiatrist's subjective evaluation
- •Patient treated with lithium/antipsychotics/benzodiazepines (monotherapy or combination therapy)
- •Patient capable of performing speech assessments and responding to questionnaires on a smartphone
- •Patient able to speak, read, and understand French
- •Patient enrolled in a social security system
排除标准
- •Patient with a cognitive disorder
- •Patient suffering from a known demential disorder
- •Patient receiving treatment for a known addictive disorder
- •Patient with a condition affecting speech production
- •Patient with a neurological disorder (stroke or neurodegenerative diseases)
- •Patient under legal protection, guardianship, or curatorship
- •Subjects deprived of liberty by judicial or administrative decision
- •Pregnant or breastfeeding women
结局指标
主要结局
Occurrence of relapses during the study period
时间窗: From enrollment to the end of study at 6 months
Occurrence of relapse episodes during the 6-month follow-up period
Changes from Baseline in the bipolar disorder severity assessed by the Clinical Global Impression scale
时间窗: Month 0, Month 6
Bipolar Disorder severity will be assessed by the investigator with CGI (Clinical Global Impression) scale. Score range (min - max): 0 - 7 for the severity subscale symptomatic remission correspond to a score ≤3 (CGI).
Changes from Baseline in the maniac symptoms severity at the Young Mania Rating Scale
时间窗: Month 0, Month 6
Maniac symptoms severity will be assessed by the investigator with the YMRS (Young Mania Rating Scale). Score range (min - max): 0-60 higher score relates to worse maniac symptoms severity.
Voice interviews recorded on Callyope application
时间窗: Once a week, from Month 0 to Month 6 (end of the study visit)
The analysis of the interviews (acoustic and linguistic features) will be implemented in a voice model predicting a score.
Changes from Baseline in the depression score measured by the Montgomery-Asberg Depression Rating Scale
时间窗: Month 0, Month 6
Depression severity will be assessed by the investigator with the MADRS (Montgomery-Asberg Depression Rating Scale) scale. Score range (min - max): 0-60 higher score relates to worse depression severity
次要结局
- Changes from Baseline in symptoms (depression, anxiety, functional autonomy, fatigue)(Once a week, from Month 0 to Month 6 (end of the study visit))
- Age(Month 0)
- Sex(Month 0)
- Weight(Month 0)
- Plasma lithium concentration(Up to 6 months (end of the study))
- Plasma drug concentration(Up to 6 months (end of study))
- Changes from Baseline in anxiety symptoms(Once a week, from Month 0 to Month 6 (end of the study visit))
- Sleep disturbances severity (Athens Insomnia Scale total score)(Once a week, from Month 0 to Month 6 (end of the study visit))
- Medication adherence measured by Medication Adherence Report Scale total score(Once a week, from Month 0 to Month 6 (end of the study visit))
- Fatigue measured by the Multidimensional Fatigue Inventory(Month 0, Month 6)
- Quality of social relationships measured by the Social Network Index(Month 0, Month 6)
- Assessment of Loneliness Using the UCLA 3-Item Loneliness Scale(Month 0, Month 6)
- Mean number of steps(Continuous monitoring, from Month 0 to the end of study (Month 6))
- Sleep duration(Continuous monitoring, from Month 0 to the end of study (Month 6))
- Heart rate variability(Continuous monitoring, from Month 0 to the end of study (Month 6))
- Blood oxygen saturation(Continuous monitoring, from Month 0 to the end of study (Month 6))
- Body temperature(Continuous monitoring, from Month 0 to the end of study (Month 6))
- Sleep apnea(Continuous monitoring, from Month 0 to the end of study (Month 6))