Clinical trial NCT06823024: Assess the Utility of a Speech-based Machine Learning Algorithm to Predict Treatment Response to Psychiatric Interventions
Official title: An Observational, Prospective Study to Assess the Utility of a Speech-based Machine Learning Algorithm to Predict Treatment Response to Psychiatric Interventions
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Obsessive Compulsive Disorder (OCD)
Bipolar Disorders
Major Depressive Disorder
Post-Traumatic Stress Disorder, PTSD
Generalized Anxiety Disorder (GAD)
Keywords: TMS
Spravato
Esketamine
Treatment response
Speech
Artificial Intelligence
Natural Language Processing
Acoustic Analysis
Acoustic Biomarkers
Vocal Biomarkers
Machine Learning
Mental Health
Speech Analysis
Lead sponsor: Psyrin Inc.
Sponsor class: INDUSTRY
First posted: 2025-02-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study aims to enroll 200 patients diagnosed with Major Depressive Disorder (MDD), Post-Traumatic Stress Disorder (PTSD), or Bipolar Disorder (BD) who are undergoing repetitive Transcranial Magnetic Stimulation (TMS) or Spravato (esketamine) treatment. Participants will represent diverse racial, ethnic, and gender categories, with ages ranging from 18 to 68 years. The eligibility criteria have been designed to capture a wide range of patients, maintaining high ecological validity and ensuring diverse samples.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Outpatient status
2. Men and women aged 18-68 years
3. Capable and willing to provide informed consent
4. Able to adhere to the treatment schedule
5. Stable on medication for at least 2 months with no anticipated changes during the study period
6. Diagnosis of MDD, PTSD, or BD
7. Eligible for and scheduled to receive TMS or Spravato (esketamine) treatment to alleviate symptoms of MDD, PTSD, GAD, OCD or BD
8. Fluent in English
9. Access to a stable internet connection and an electronic device with a microphone for voice recording

Exclusion Criteria:

1. Use of any investigational drug within four weeks of the baseline visit
2. 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.
3. Intoxication during speech assessments
4. Cognitive impairment that would interfere with study participation or data quality
5. Lack of fluency in English

Primary outcomes:
measure: Treatment response
timeFrame: Change between Baseline and Week 0 (post-intervention)
Secondary outcomes:
measure: Remission
timeFrame: Change between Baseline and Week 0 (post-intervention), Week 4 (post-intervention)
measure: Stability of treatment response
timeFrame: Change between Baseline and Week 4 (post-intervention)
measure: Distress caused by the online speech assessment
timeFrame: Week 4
Other outcomes:
Locations:
city: Sunnyvale
country: United States
facility: Acacia Clinics
state: California
city: New York City
country: United States
facility: Fermata Health
state: New York
Study officials:
affiliation: Psyrin Inc.
name: Julianna Olah, B.Sc., M.A., M.Sc., Ph.D.
role: STUDY_DIRECTOR
References: