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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Julianna Olah, B.Sc., M.A., M.Sc., Ph.D. | Psyrin Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acacia Clinics | Sunnyvale | California | 94087 | United States | ||
| Fermata Health |
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| Label | URL |
|---|---|
| Study website | View source |
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Audio of speech collected
≥ 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 |
| New York |
| New York |
| 11249 |
| United States |
| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| D001714 | Bipolar Disorder |
| D003865 | Depressive Disorder, Major |
| D003130 | Combat Disorders |
| D000098647 | Generalized Anxiety Disorder |
| D013060 | Speech |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D003866 | Depressive Disorder |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D014705 | Verbal Behavior |
| D003142 | Communication |
| D001519 | Behavior |
| D010549 | Personal Satisfaction |
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