NCT07298278Not yet recruiting
Anticipating Depressive and Manic Episodes in Bipolar Disorders Using Vocal Biomarkers
Source: ClinicalTrials.gov · Last updated 23 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 170 (estimated)
- First submitted
- 1 Dec 2025
- Start date
- 20 Dec 2025
- Primary completion date
- May 2027
- Lead sponsor
- Centre Hospitalier St Anne
- Diseases
- Bipolar disorder
- NCT number
- NCT07298278
What you commit to
- Study type: Interventional
- Planned participants: 170
- From 20 Dec 2025 to the primary completion date, May 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient receiving treatment for a known addictive disorder
Other illness
- Patient with a cognitive disorder
- Patient suffering from a known demential disorder
- Patient with a condition affecting speech production
- Patient with a neurological disorder (stroke or neurodegenerative diseases)
Other
- Patient under legal protection, guardianship, or curatorship
- Subjects deprived of liberty by judicial or administrative decision
- Pregnant or breastfeeding women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.