NCT06823024Enrolling by invitation
Assess the Utility of a Speech-based Machine Learning Algorithm to Predict Treatment Response to Psychiatric Interventions
An Observational, Prospective Study to Assess the Utility of a Speech-based Machine Learning Algorithm to Predict Treatment Response to Psychiatric Interventions
Source: ClinicalTrials.gov · Last updated 18 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a research study looking at whether the way people speak can help predict how well they'll respond to certain mental health treatments. The Main Goal: The researchers want to see if computer analysis of a person's speech patterns can predict whether they'll respond well to two specific treatments: TMS (Transcranial Magnetic Stimulation) and Spravato (a nasal spray medication). They're focusing on people with depression, bipolar disorder, OCD, anxiety, and PTSD. How It Works: 200 people with these conditions will participate in the study.Participants will record themselves speaking for about 12 minutes, responding to six different prompts.They'll do these recordings before treatment starts, daily during treatment, right after treatment ends, and again four weeks later. Doctors will track how well people are doing using various questionnaires and rating scales The researchers will look for connections between speech patterns and treatment success. The study will last 12 months. What Makes Someone a "Treatment Success": The study considers treatment successful if a person's symptoms improve significantly (specifically, a 2-point or greater reduction on a clinical rating scale (called Clinical Global Impression) and stays improved during the follow-up period (4-weeks). Why This Matters: If successful, this research could lead to a simple, non-invasive way to help doctors predict which treatments might work best for different patients. This could help people get the most effective treatment more quickly and help healthcare providers use their resources more efficiently. Safety Consideration The researchers will also check whether doing the speech assessments causes any distress to participants, making sure the evaluation process itself is safe and comfortable.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 12 Jan 2025
- Start date
- 18 Feb 2025
- Primary completion date
- Jan 2026
- Lead sponsor
- Psyrin Inc.
- Diseases
- Depression, Bipolar disorder
- NCT number
- NCT06823024
What you commit to
- Study type: Observational
- Planned participants: 200
- From 18 Feb 2025 to the primary completion date, Jan 2026
- 2 sites in 1 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
- Use of any investigational drug within four weeks of the baseline visit
- If participating in psychotherapy, the patient must have been in stable treatment for at least three months before study entry, with no anticipated changes in the frequency of therapeutic sessions or therapeutic focus during the TMS or Spravato treatment.
Other illness
- Cognitive impairment that would interfere with study participation or data quality
Other
- Intoxication during speech assessments
- Lack of fluency in English
Who the study is looking for
- Outpatient status
- Men and women aged 18-68 years
- Capable and willing to provide informed consent
- Able to adhere to the treatment schedule
- Stable on medication for at least 2 months with no anticipated changes during the study period
- Diagnosis of MDD, PTSD, or BD
- Eligible for and scheduled to receive TMS or Spravato (esketamine) treatment to alleviate symptoms of MDD, PTSD, GAD, OCD or BD
- Fluent in English
- Access to a stable internet connection and an electronic device with a microphone for voice recording
Age in the registry: 18 years to 68 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fermata Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Acacia Clinics Coordinator of this site? Confirm its status | Sunnyvale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.