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

NCT ID: NCT06823024

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-18
• Study Completion Date: 2026-03-31

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)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants prescribed esketamine

Participants who in their normal course of treatment are prescribed and are administered Spravato (esketamine) within 4 weeks of baseline assessment.

No interventions assigned to this group

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Psyrin Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: STUDY_DIRECTOR

Psyrin Inc.

Locations

Acacia Clinics

Sunnyvale, California, United States

Fermata Health

New York, New York, United States

Countries

United States

Other Identifiers

PSYRIN-0005

Identifier Type: -

Identifier Source: org_study_id