Obsessive Compulsive Disorder (OCD)NCT06823024
Assess the Utility of a Speech-based Machine Learning Algorithm to Predict Treatment Response to Psychiatric Interventions
An observational study of Obsessive Compulsive Disorder (OCD) and Bipolar Disorders, run by Psyrin Inc. at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Obsessive Compulsive Disorder (OCD), Bipolar Disorders, Major Depressive Disorder
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Feb 2025to Mar 2026
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Fermata Health
New York, New York, 11249
Acacia Clinics
Sunnyvale, California, 94087
About this study
Official title: 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:
Read more
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
- Medical subject headings
- Obsessive-Compulsive Disorder, Bipolar Disorder, Depressive Disorder, Major, Combat Disorders, Generalized Anxiety Disorder, Speech, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change between Baseline and Week 0 (post-intervention)
Secondary outcomes (3)
Remission
Symptoms below the threshold for having the disorder according to CGI-S and clinical judgement.
Measured: 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).
Measured: Change between Baseline and Week 4 (post-intervention)
Distress caused by the online speech assessment
Self-reported distress caused by the online speech assessment.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start18 Feb 2025
- Primary completionJan 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive Compulsive Disorder (OCD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Psyrin Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julianna Olah, B.Sc., M.A., M.Sc., Ph.D., Study director, Psyrin Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823024
- Sponsor's protocol ID
- PSYRIN-0005
- Status last verified
- Feb 2025
- First submitted
- 12 Jan 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Prospective Study to Assess the Utility of a Speech-based Machine Learning Algorithm to Predict Treatment Response to Psychiatric Interventions
- ClinicalTrials.gov ID
- NCT06823024
- Acronym / sponsor ID
- PSYRIN-0005
- 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
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Psyrin Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment response
Time frame: Change between Baseline and Week 0 (post-intervention)
≥ 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).
3 secondary outcomes
Remission
Time frame: Change between Baseline and Week 0 (post-intervention), Week 4 (post-intervention)
Stability of treatment response
Time frame: Change between Baseline and Week 4 (post-intervention)
Distress caused by the online speech assessment
Time frame: Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julianna Olah, B.Sc., M.A., M.Sc., Ph.D. study director
Psyrin Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obsessive Compulsive Disorder (OCD) and Bipolar Disorders, run by Psyrin Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment response (time frame: Change between Baseline and Week 0 (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.