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Enrolling by invitationNCT06823024Updated Mar 18, 2025

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

An observational study in Obsessive Compulsive Disorder (OCD), Bipolar Disorders and Major Depressive Disorder, sponsored by Psyrin Inc.. Enrolling by invitation at 2 sites in United States. Open to participants aged 18 Years to 68 Years. Per ClinicalTrials.gov, last updated 2025-03-18.

Sponsored by Psyrin Inc. · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 68 Years
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's planned enrollment of 200 is above the median of 150 across 653 observational studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Psyrin Inc. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 68 Years
Sexes eligible
All
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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Target follow-up
4 Weeks
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

06

What researchers measure

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).

    Time frame: Change between Baseline and Week 0 (post-intervention)

Secondary outcomes

  1. Remission

    Symptoms below the threshold for having the disorder according to CGI-S and clinical judgement.

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

  2. 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).

    Time frame: Change between Baseline and Week 4 (post-intervention)

  3. Distress caused by the online speech assessment

    Self-reported distress caused by the online speech assessment.

    Time frame: Week 4

07

Study locations

2 sites
  • Acacia Clinics
    Sunnyvale, California 94087, United States
  • Fermata Health
    New York City, New York 11249, United States
08

References and documents

Related links

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06823024
Lead sponsor
Psyrin Inc.
Responsible party
Sponsor
First posted
Feb 12, 2025
Start date
Feb 18, 2025
Primary completion
Jan 2026 (estimated)
Completion
Mar 2026 (estimated)
Last update
Mar 18, 2025

Study contacts

Julianna Olah, B.Sc., M.A., M.Sc., Ph.D.
study director · Psyrin Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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