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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Major Depressive Disorder; Bipolar Disorders; Obsessive Compulsive Disorder (OCD); Generalized Anxiety Disorder (GAD); Post-Traumatic Stress Disorder, PTSD

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• United States
  • California
    • Sunnyvale, California, United States, 94087
      • Acacia Clinics
  • New York
    • New York City, New York, United States, 11249
      • Fermata Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Participants prescribed esketamine; Participants who in their normal course of treatment are prescribed and are administered Spravato (esketamine) within 4 weeks of baseline assessment.
Participants prescribed TMS; Participants who in their normal course of treatment are prescribed and are administered repetitive transcranial magnetic stimulation within 4 weeks of baseline assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment response	≥ 2 points symptom severity reduction between baseline and after-treatment evaluation on the clinical global impression severity scale (CGI-S) (between 1, normal, not at all ill, and 7, among the most extremely ill patients).	Change between Baseline and Week 0 (post-intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remission	Symptoms below the threshold for having the disorder according to CGI-S and clinical judgement.	Change between Baseline and Week 0 (post-intervention), Week 4 (post-intervention)
Stability of treatment response	≥ 2 points symptom severity reduction between baseline and follow-up evaluation after-treatment on the clinical global impression severity scale (CGI-S) (between 1, normal, not at all ill, and 7, among the most extremely ill patients).	Change between Baseline and Week 4 (post-intervention)
Distress caused by the online speech assessment	Self-reported distress caused by the online speech assessment.	Week 4

Collaborators and Investigators

• Sponsor: Psyrin Inc.
• Investigators: Study Director: Julianna Olah, B.Sc., M.A., M.Sc., Ph.D., Psyrin Inc.

Publications and helpful links

Helpful Links

• Study website

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: January 12, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Mental Health; Artificial Intelligence; Treatment response; TMS; Speech; Esketamine; Natural Language Processing; Machine Learning; Acoustic Analysis; Acoustic Biomarkers; Vocal Biomarkers; Speech Analysis; Spravato
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Bipolar and Related Disorders; Mental Disorders; Mood Disorders; Anxiety Disorders; Depressive Disorder; Bipolar Disorder; Depressive Disorder, Major; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Obsessive-Compulsive Disorder
• Other Study ID Numbers: PSYRIN-0005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No