Assess the Utility of a Speech-based Machine Learning Algorithm to Predict Treatment Response to Psychiatric Interventions

NCT06823024 | Enrolling By Invitation

• 1 other identifier: PSYRIN-0005
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Remission

  Change between Baseline and Week 0 (post-intervention), Week 4 (post-intervention)

• Stability of treatment response

  Change between Baseline and Week 4 (post-intervention)

• Distress caused by the online speech assessment

  Week 4

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.
• Intoxication during speech assessments
• Cognitive impairment that would interfere with study participation or data quality
• Lack of fluency in English

Sponsors & Collaborators

• Psyrin Inc.: lead

Study Sites (2)

Acacia Clinics

Sunnyvale, California, 94087, United States

Location

Fermata Health

New York, New York, 11249, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Audio of speech collected

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Bipolar Disorder; Depressive Disorder, Major; Combat Disorders; Generalized Anxiety Disorder; Speech; Psychological Well-Being

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Depressive Disorder; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Verbal Behavior; Communication; Behavior; Personal Satisfaction

Study Officials

• Julianna Olah, B.Sc., M.A., M.Sc., Ph.D.

  Psyrin Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2025
• First Posted: February 12, 2025
• Study Start: February 18, 2025
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 18, 2025

Record last verified: 2025-02

Locations

US (2)